[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depression":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,588,0,25,[9,56,77,107,126,158,179,207,231,251,282,311,335,370,394,422,447,473,493,520,542,568,589,615,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053319","cbt-i-vs-mbti-for-traumatic-brain-injury-tbi-related-insomnia-and-post-traumatic-stress-symptoms-100053319",false,"NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","ALL","18 Years",{"count":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[27,28,29,30,31,32,33,34,35,36],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[27,28,38,29,39,35,40,41,42],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":47},"2024-05-10",{"date":51,"type":21},"2027-06",{"name":53,"class":54},"Johns Hopkins University","OTHER",5,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100054001","tavns-or-tms-or-both-for-depression-100054001","NCT05725239","taVNS or TMS or Both for Depression","Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)","Inclusion Criteria:\n\n* 18-75 years old\n* Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode\n* Able to provide informed consent\n* English speaking and can read and write\n* 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20\n* Not responding to talking therapy.\n\nExclusion Criteria:\n\n* Preexisting neurological disorders, or dementia\n* History of major head trauma\n* Life expectancy \\\u003C1 year\n* Any type of cognitive impairment that would require approval\u002Fsignature of a legal guardian\u002Frepresentative for participation\n* A score of \\>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality\n* Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded\n* Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.","75 Years",{"count":65,"type":21},24,[24],"The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.",[29],{"date":46,"type":47},{"date":71,"type":47},"2023-03-14",{"date":73,"type":21},"2026-07-01",{"name":75,"class":54},"Medical University of South Carolina",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100053248","neural-derived-plasma-exosomal-micrornas-as-promising-novel-biomarkers-for-suicidality-and-treatment-outcome-in-adolescents-100053248","NCT05437588","Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents","Inclusion Criteria:\n\nAll participants:\n\n1. Physically healthy\n2. willing and able to provide informed consent (if under 18 also parent or guardian consent)\n\nMDD participants:\n\n1. A definite diagnosis of DSM-5\n2. a Children's Depression Rating Scale-Revised (CDRS-R) score \\>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \\>=4 rated over the last two weeks.\n\nSuicide attempt group:\n\n1\\. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale.\n\nNon-psychiatric controls:\n\n1\\. No history of any major mental illness (excluding specific phobia) or substance use disorder.\n\nExclusion Criteria:\n\n* Exclusion criteria:\n\n  1. Pregnancy or lactation\n  2. post-partum state (being within 2 months of delivery or miscarriage);\n  3. homicide risk as determined by clinical interview\n  4. any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine\u002Fcaffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.\n  5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months\n  6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.",true,"10 Years","24 Years",{"count":87,"type":21},240,[24],"This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.",[91,92,93,94,29,95,96,97,98],"Major Depressive Disorder","Suicidal Ideas","Suicide, Attempted","MDD","Depression, Teen","Depression and Suicide","Depression in Adolescence","Suicide",{"date":46,"type":47},{"date":101,"type":47},"2022-10-01",{"date":103,"type":21},"2027-06-30",{"name":105,"class":54},"University of Alabama at Birmingham",2,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":76},"100053819","feasibility-of-a-technology-based-intervention-for-depression-referral-uptake-in-cancer-survivors-100053819","NCT07091968","Feasibility of a Technology-Based Intervention for Depression Referral Uptake in Cancer Survivors","Pilot Feasibility Trial to Evaluate a Technology-Enabled Approach to Enhance Depression Referral Uptake Among Cancer Survivors","Inclusion Criteria:\n\n* age \\> 18 years\n* diagnosis of cancer\n* upcoming appointment in an HCC or HCN oncology clinic within 14 days\n* English proficiency\n* ownership of a cellphone with SMS text capability.\n* elevated depressive symptoms at screening (as measured by \\> 3 on the PHQ-2)\n\nExclusion Criteria:\n\n* cognitive impairment as evaluated by attending physician\n* currently receiving counseling for depression",{"count":115,"type":21},60,[24],"Depression is very common in cancer survivors but there are challenges to linking those in need of treatment efficiently to care. In this study, investigators will test the feasibility and acceptability of a new text-based approach to connect cancer survivors with depression with care.",[119,29],"Cancer",{"date":46,"type":47},{"date":122,"type":47},"2026-01-16",{"date":124,"type":21},"2026-12",{"name":75,"class":54},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":133,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":145,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":76},"100053713","facilitated-transitions-from-postpartum-to-primary-care-coordination-for-people-with-chronic-conditions-100053713","NCT06557005","Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions","Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions","Inclusion Criteria\n\n* Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)\n* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age\n* If postpartum, has a neonate that is currently living at the time of enrollment\n* Has one or more of the following conditions listed in the \"Problem List,\" \"Medical History,\" or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):\n\n  * Chronic or essential hypertension\n  * Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)\n  * Type 1 or 2 diabetes (i.e., pre-existing diabetes)\n  * Gestational diabetes\n  * Class II Obesity (pre-pregnancy body mass index ≥35 kg\u002Fm2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg\u002Fm2)\n  * Depression or anxiety disorder\n* Has a primary care clinician listed in the patient's medical record\n* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities\n* Able to read\u002Fspeak English or Spanish language\n* Is age ≥18 years old\n\nExclusion Criteria\n\n• Any individual not meeting all inclusion criteria","FEMALE",{"count":135,"type":21},1320,[24],"The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \\>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.",[139,140,141,142,143,29,144],"Hypertension","Diabetes","Postpartum","Pregnancy","Anxiety","Obesity",[146,147,148,149],"Postpartum Care","Primary Care","Care Transitions","Chronic Disease","2026-07-09",{"date":46,"type":47},{"date":153,"type":47},"2025-05-23",{"date":155,"type":21},"2028-05-23",{"name":157,"class":54},"Massachusetts General Hospital",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":164,"maxAge":18,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":76},"100610175","developing-a-digital-intervention-for-adolescent-nonsuicidal-self-injury-100610175","NCT07224165","Developing a Digital Intervention for Adolescent Nonsuicidal Self-injury","Inclusion Criteria:\n\n* Current NSSI (NSSI on 2 or more days in the last month\n* English language skills sufficient to engage in the consent and intervention procedures\n* Age 14-18\n* Access to smartphone\n\nExclusion Criteria:\n\n* Severe mental health diagnoses for which this intervention would be inappropriate (psychotic disorders, active manic episodes)\n* Severe suicide risk, including suicidal ideation with a plan and intent to act\n* Current engagement in psychotherapy","14 Years",{"count":166,"type":21},80,[24],"This is a feasibility trial of a digital mental health intervention aimed at adolescents (ages 14-18) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. The study has two arms: a self-guided DMHI and an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.",[170,29,143],"Nonsuicidal Self-injury",{"date":172,"type":47},"2026-07-02",{"date":174,"type":47},"2026-06-04",{"date":176,"type":21},"2027-07-31",{"name":178,"class":54},"Northwestern University",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100573587","phase-3-e-mindfulness-approaches-for-living-after-breast-cancer-100573587","NCT06748222","E-Mindfulness Approaches for Living After Breast Cancer","Harnessing E-Mindfulness Approaches for Living After Breast Cancer-HEAL-ABC","HEAL-ABC","Inclusion Criteria:\n\n* The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information.\n* The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis.\n* The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.\n* The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8).\n* Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4\u002F6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.)\n* Participant must be able to understand, speak, read, and write in English or Spanish.\n* Participant must be willing to participate in a 6-week program to receive training in mindfulness.\n* Participant must be able to use a smartphone, tablet, or other digital device.\n* Sex assigned at birth must be female.\n\nExclusion Criteria:\n\n* Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 .\n* Any history or current evidence of recurrent or metastatic breast cancer.\n* Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible.\n* Currently pregnant or planning to become pregnant in the near future.\n* Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.","50 Years",{"count":189,"type":21},402,[191],"PHASE3","NRG-CC015 is a prospective, randomized phase III clinical trial to evaluate the efficacy of two distinct digital approaches for delivering a mindfulness-based intervention: a live, instructor-led version delivered over Zoom (MAPs LO), and an app-based, self-paced version (MAPs App). Participants will include younger breast cancer survivors (BCS) who were diagnosed with breast cancer at or before age 50 years, have completed their primary cancer treatment (i.e., surgery, radiation, and\u002For chemotherapy) at least 6 months earlier, and report elevated depressive symptoms.",[194,29],"Breast Cancer",[194,196,197,198],"Mindfulness","Meditation","Digital",{"date":172,"type":47},{"date":201,"type":47},"2025-06-27",{"date":203,"type":21},"2030-02-28",{"name":205,"class":54},"NRG Oncology",364,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":76},"100493325","phase-1-18fpf-06445974-to-image-pde4b-in-major-depressive-disorder-using-pet-100493325","NCT05703685","[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible for this study, MDD participants must meet all of the following criteria:\n\n* 18 to 70 years of age.\n* Female participants of childbearing potential must be using a medically acceptable means of contraception.\n* Be in good general health as evidenced by medical history and physical examination. Stable medical conditions as assessed by their primary care provider (PCP) and\u002For in-house clinician are permitted to join the study.\n* Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* All participants must have undergone a screening assessment under protocol 01-M-0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .\n* Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).\n* Participants must have an initial score on the MADRS \\>= 18 or HAM-D \\>= 15 within one week of study entry.\n* Participants must be experiencing an MDE lasting at least four weeks.\n* All MDD participants must have a PCP or psychiatrist in the community.\n* Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:\n\n* Aged 18 to 70 years old.\n* Female participants of childbearing potential must be using a medically acceptable means of contraception.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n* Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with MDD who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n* Participants must be free of all prohibited medications for at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified\n\n(including herbal products), and sedatives\u002Fhypnotics.\n\n* Current psychotic features, a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.\n* Participants with a history of psychiatric inpatient hospitalization within the past year.\n* Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n* Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n* Participants with suicidal ideation within the past 6 months.\n* Participants with suicidal behavior within the past 12 months.\n* Participants who have a history of aggressive behavior towards others.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* HIV infection.\n* Pregnancy.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nHealthy controls who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics.\n* Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n* Participants who have a history of major depressive disorder.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* HIV infection.\n* Pregnancy.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Use of cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin).\n* Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigator.","70 Years",{"count":215,"type":21},108,[217],"PHASE1","Background:\n\nMajor depressive disorder (MDD) is a psychiatric condition. People with MDD have occasional bouts of depressive symptoms; these bouts are called major depressive episodes (MDEs). Researchers want to know if people having MDEs have lower levels of an enzyme called PDE4B in their brains.\n\nPrimary Objective: To determine whether PDE4B is reduced in the brains of individuals with MDD experiencing a major depressive episode (MDE). Secondary Objectives: To determine the optimal length of scanning and the retest variability and reliability of \\[18F\\]PF-06445974, and whether PDE4B binding correlates with clinical rating scales. To measure if PDE4B radioligand binding can be blocked by taking apremilast.\n\nEligibility:\n\nPeople aged 18-70 years with MDD. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits.\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. Some participants may have a psychiatric assessment; they will answer questions about their state of mind and related topics.\n\nParticipants will have magnetic resonance imaging (MRI) of the brain. They will lie on a table that slides into a metal cylinder.\n\nParticipants will have a positron emission tomography (PET) scan. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer (\\[18F\\]PF-06445974) will be injected through the catheter. Participants will lie on a table that slides into a doughnut-shaped machine. The scan will last up to 4 hours with a 15-minute break.\n\nParticipants blood pressure, heart rate, and breathing will be monitored before, during, and after the PET scan. A second catheter will be inserted in the artery of the wrist so blood can be drawn during the scan.\n\nSome participants may return for a second PET scan; have a lung scan or receive apremilast.\n\nhttps:\u002F\u002Fnimhcontent.nimh.nih.gov\u002Fstart\u002Fsurveys\u002F?s=KE88DXXPLDFHHTF8",[29],[221,29,222],"PET Imaging","Phosphodiesterase-4",{"date":172,"type":47},{"date":225,"type":47},"2023-06-22",{"date":227,"type":21},"2029-04-11",{"name":229,"class":230},"National Institute of Mental Health (NIMH)","NIH",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":76},"100407245","phase-1-pet-imaging-of-cyclooxygenase-in-participants-with-major-depressive-disorder-mdd-100407245","NCT04582916","PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)","* INCLUSION CRITERIA:\n\nPatients: In order to be eligible for this study, MDD participants must meet all of the following criteria:\n\n1. Aged 18 to 70 years old.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n3. Participants must be in good general health as evidenced by medical history and physical examination.\n4. Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n5. All participants must have undergone a screening assessment under protocol 01M0254, The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants .\n6. Participants must fulfill DSM-5 criteria for major depression (MDD) without psychotic features, as based on clinical assessment and structured diagnostic interview (SCID-P).\n7. Participants must have an initial score on the MADRS greater than or equal to 18 or HAM-D greater than or equal to 15 within one week of study entry.\n8. Participants must be experiencing an MDE lasting at least four weeks.\n9. Unmedicated participants in both Groups must be medication-free for at least two weeks (5 weeks for aripirazole, brexpiprazole, fluoxetine) prior to first screen visit. Medications will not be discontinued for the purpose of this study.\n10. Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n11. Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Controls: In order to be eligible to participate in this study, control subjects must meet all of the following criteria:\n\n1. Aged 18 to 70 years old.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception.\n3. Able to provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with MDD who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg\u002FdL.\n2. Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics. Medicated participants in Group B may continue their therapy.\n3. Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.\n4. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-5.\n5. Participants with a history of DSM-5 substance use disorder (except for caffeinei or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily lfe.\n6. Participants who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n7. Participants who have a history of aggressive behavior towards others.\n8. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n9. Participants seeking treatment or a change in treatment and may be referred to the community or to another research study.\n10. Are unable to travel to the NIH.\n11. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n12. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n13. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n14. Pregnancy.\n15. HIV Infection.\n16. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nHealthy controls who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n2. Participants must be free of all prohibited medications or at least two weeks (5 weeks for aripiprazole, brexpiprazole, fluoxetine) prior to screen visit. These medications include antidepressants, anti-inflammatory drugs (except for study medication celecoxib), antipsychotics, anxiolytics, psychotropic drugs not otherwise specified (including herbal products), and sedatives\u002Fhypnotics.\n3. Participants should not have taken NSAIDs for two weeks prior to the PET scan. Aspirin, corticosteroids, or immunosuppressants (e.g. methotrexate) must not have been taken in the prior month.\n4. Participants with a history of DSM-5 substance use disorder (except for caffeine or nicotine dependence) within the preceding three months. In addition, participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n5. Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and\u002For lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n9. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n10. Pregnancy.\n11. HIV Infection.\n12. Be NIMH staff or an NIH employee who is a subordinate\u002Frelative\u002Fco-worker of the investigators.\n\nEXCLUSION OF CHILDREN:\n\nBecause this protocol has more than minimal risk from radiation exposure without possibility of direct benefit, inclusion of children is not appropriate.\n\nEXCLUSION OF PREGNANT OR BREASTFEEDING WOMEN:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk.\n\nEXCLUSION OF PARTICIPANTS WHO ARE HIV POSITIVE:\n\nPersons with HIV infection are excluded because HIV infection itself may cause neuroinflammation, and we wish to specifically study the effect of depression on neuroinflammation.\n\nEXCLUSION OF NON ENGLISH SPEAKING PARTICIPANTS:\n\nNon-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator.",{"count":238,"type":21},64,[217],"Background:\n\nResearchers developed \\[11C\\]MC1, a radioligand for cyclooxygenase-2 (COX-2). COX-2 is an enzyme induced in the brain during inflammation. Researchers want to see the levels of COX-1 (measured as distribution volume VT) are elevated in the brain of two groups of mood disorders patients undergoing MDE relative to the control group.\n\nObjective:\n\nTo determine whether COX-1 and COX-2 are detectable in the brains of individuals with MDD experiencing a major depressive episode (MDE).\n\nEligibility:\n\nPeople aged 18-70 years with MDD and Healthy Volunteers aged 18 70 years.\n\nDesign:\n\nGroup A: MDD participants will be studied with the same dose of \\[11C\\]MC1 before and after administration of 600 mg celecoxib; the study is neither randomized nor placebo-controlled. Group B: MDD participants, both medicated and unmedicated, will be studied with \\[11C\\]PS13 and compared to healthy volunteers..\n\nhttps:\u002F\u002Fnimhcontent.nimh.nih.gov\u002Fstart\u002Fsurveys\u002F?s=TJW4RA4WN3LDD988",[29],[221,243,244,29],"Inflammation","Cyclooxygenase-2",{"date":172,"type":47},{"date":247,"type":47},"2021-07-20",{"date":249,"type":21},"2030-04-11",{"name":229,"class":230},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":271,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":281},"100607956","reduction-of-depression-in-people-with-disabilities-through-dual-treatment-digital-cbt--nbhwc-coaching-100607956","NCT07195292","Reduction of Depression in People With Disabilities Through Dual Treatment: Digital CBT & NBHWC Coaching","Reduction of Depression Through Dual Mental Health Treatment: Digital-Based Cognitive Behavioral Therapy (CBT) and National Board for Health and Wellness Coaching (NBHWC) Mental Health Coaches for People With Disabilities (ReDu)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Presence of self-reported hearing or mobility disability\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n* Male or female, age 22 years or older\n* A score of 17 or higher on the HAM-D\n* Clinical diagnosis of depression based on DSM-5 diagnostic criteria\n* Willingness to adhere to the Toivoa-002 or sham regimen once per week, including scheduling and weekly meetings with coaches\n* Access to necessary resources for participating in a technology-based intervention (e.g., Android phone, iPhone, iPad, internet access)\n* Treatment stability (no changes in psychotropic medication or psychotherapy treatment in the 30 days prior to study entry)\n* Able to read and speak English fluently\n* Resident of the United States and living in the United States for the duration of the trial\n\nExclusion Criteria:\n\n* Medical diagnosis of psychotic disorder or bipolar disorder\n* Participation in another treatment trial at the time of study\n* Substance use disorder in the past 12 months (excluding tobacco)\n* Suicide attempt in the past year or elevated suicide risk other than passive ideation (i.e., endorsing items reflecting intent, identifying means, suicide planning, or suicide-related preparations).\n* Currently pregnant, breastfeeding, or planning to become pregnant during the treatment period","22 Years",{"count":260,"type":21},200,[24],"The purpose of this study is to see if a mobile-delivered mental health program called Toivoa-002, which combines digital cognitive behavioral therapy (CBT) with personal mental health coaching, can effectively reduce depression in adults with hearing or mobility disabilities. The study aims to answer whether this dual-intervention digital service is more effective at lowering depression symptoms over an 8-week period than a \"sham\" digital program that is developed to look similar but does not contain active therapeutic content. The investigators hypothesize that participants who use the Toivoa-002 program will show significantly greater reductions in depression compared to those using the sham program, and that these mental health benefits will last through a 12-week follow-up. Adults within the disability community frequently encounter unique environmental and societal barriers - such as limited physical accessibility, transportation challenges, and workplace inflexibility - that can directly drive or worsen depression. By offering a fully remote and accessible mobile tool, this study seeks to determine if a digital health service can deliver scalable, effective depression relief tailored to the lived experiences of people with disabilities.",[264,29,265],"Hearing Disability","Mobility Disability",[29,143,267,268,33,269,270],"People with Hearing or Mobility Disability","Accessible Health for People with Disabilities and Veterans","Cognitive Behavioral Therapy with Coaches","Coaches","NOT_YET_RECRUITING","2026-06-30",{"date":172,"type":47},{"date":275,"type":21},"2026-08",{"date":277,"type":21},"2027-03",{"name":279,"class":280},"Toivoa Inc","INDUSTRY",4,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":298,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":76},"100541211","capable-transplant-100541211","NCT06326905","CAPABLE Transplant","Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program","Inclusion Criteria:\n\n* Deceased Donor Waitlist\n* ≥18 years old\n* Community dwelling\n* Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing OR Active on the waitlist and low-income\n\nExclusion Criteria:\n\n* Living Donor Waitlist\n* Severe cognitive impairment\n* Inactivity expected to last \\> 3 months (eg cancer treatment)\n* \\>4 hospitalizations in the last 12 months\n* Current home nursing, physical or occupational therapy","99 Years",{"count":291,"type":21},43,[24],"The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail\u002F frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.",[295,29,296,297],"Quality of Life","End Stage Renal Disease","Disability Physical",[299,300,301,302,303,304,305,296],"Activities of Daily Living","Instrumental Activities of Daily Living","Physical Function","Executive Function","Home","Intervention","Kidney Transplant",{"date":172,"type":47},{"date":308,"type":47},"2025-01-25",{"date":73,"type":21},{"name":53,"class":54},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":281},"100528589","type-i-hybrid-effectiveness-implementation-trial-of-primary-care-brief-mindfulness-training-for-veterans-100528589","NCT06162741","Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans","Inclusion Criteria:\n\nTo be eligible, participants must be:\n\n* enrolled in VA primary care through the local VA site\n* report clinically significant psychological distress as measured in at least one of three areas:\n\n  * PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor\n  * depression operationalized as 10 on the PHQ-9\n  * anxiety operationalized by 10 on the GAD-7\n\nExclusion Criteria:\n\nExclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:\n\n* gross cognitive impairment\n* suicide attempt or desire to commit suicide in the last month\n\nTo allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:\n\n* had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled\n* had a change in psychiatric medication outside of VHA primary care in the last 2 months\n* voice a preference to be directly referred to specialty mental health care\n\nVeterans with mild TBI, and alcohol\u002F substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.",{"count":318,"type":21},300,[24],"The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and\u002For PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and\u002For PTSD and increase overall functioning.",[322,29,143],"Post Traumatic Stress Disorder (PTSD)",[324,322,196,147,325,29,143,326],"Psychological Distress","Brief Intervention","Problem-solving training",{"date":172,"type":47},{"date":329,"type":47},"2024-08-19",{"date":331,"type":21},"2027-12-31",{"name":333,"class":334},"VA Office of Research and Development","FED",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":354,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100577061","phase-3-a-study-of-a-deuterated-psilocin-analog-cyb003-in-humans-with-major-depressive-disorder-100577061","NCT06793397","A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder","An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder","EMBRACE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.\n* Participant has a body mass index (BMI) of 40 kg\u002Fm2 or less (BMI ≤40 kg\u002Fm2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.\n* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.\n* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded from trial participation:\n\n* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.\n* Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.","85 Years",{"count":345,"type":21},330,[191],"The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.\n\nFor more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https:\u002F\u002Fembrace-mdd-trial.com\u002F",[349,350,351,352,353,29],"Major Depressive Disorder (MDD)","Depression in Adults","Depression - Major Depressive Disorder","Depression Disorders","Depression Disorder",[94,355,29,91,356,357,358,359,360],"Psychedelic","CYB003","CYB003-001","CYB003-002","Psilocybin","psilocin-7438","2026-06-29",{"date":272,"type":47},{"date":364,"type":47},"2025-12-10",{"date":366,"type":21},"2027-05-08",{"name":368,"class":280},"Cybin IRL Limited",68,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":271,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":76},"100531932","the-oh-happy-day-class---digital-connections-ohdc-dc-a-pilot-study-100531932","NCT06206226","The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study","The Oh Happy Day Class - Digital Connections (OHDC-DC): an Exploratory Pilot Study","OHDC-DC","Inclusion Criteria:\n\n* African-American\n* Age 18 and older\n* Experiencing depression (as evidenced by a score of 5 or higher on the PHQ-9)\n* Own a mobile phone\n\nExclusion Criteria:\n\n* Individuals who are currently receiving psychotherapy\n* Individuals who are presently experiencing suicidal ideation\n* Individuals who started psychotropic medication less than three months prior to the start of the OHDC will be excluded from the study\n* Participants scoring 25 or higher on the PHQ-9 will be screened out",{"count":379,"type":21},8,[24],"The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression.\n\nParticipants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.",[29,383,384],"Depressive Disorder","Depressive Symptoms",[386],"African American",{"date":73,"type":47},{"date":389,"type":21},"2026-07",{"date":391,"type":21},"2027-02",{"name":393,"class":54},"University of Wisconsin, Madison",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":83,"sex":17,"minAge":402,"maxAge":63,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":411,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":76},"100630118","bonding-before-birth-a-mhealth-intervention-for-first-time-expectant-couples-100630118","NCT07483515","Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples","Bonding Before Birth: A Cluster-randomized, Controlled, mHealth Trial for Developing Mindfulness and Emotional Regulation in Expectant Couples","B³","Inclusion Criteria:\n\nMothers:\n\n1. 21-50 years of age\n2. Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment\n3. Singleton pregnancy\n4. Nulliparous\n5. Plan to deliver in Singapore\n6. Proficient and able to respond to questionnaires in English\n7. Intends for herself and her child to stay in Singapore for the next 2 years\n8. Access to a smartphone\n9. Willing to download the study app\n10. Score of 7 or more in the Edinburgh Postnatal Depression Scale\n\nFathers:\n\n1. 21-75 years of age\n2. Proficient and able to respond to questionnaires in English\n3. Intends for himself and his child to stay in Singapore for the next 2 years\n4. Access to a smartphone\n5. Willing to download the study app\n\nExclusion Criteria:\n\nMothers:\n\n1. Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders\n2. Currently on oral\u002FIV steroids and\u002For thyroid medication\n3. History of thyroid disease\n4. Pregnant using assisted reproductive technologies\n5. Multiple pregnancies\n6. Currently enrolled in interventional randomised controlled trials\n7. Responded \"Yes, quite often\" to EPDS item 10 (\"The thought of harming myself has occurred to me\")\n\nFathers:\n\n1\\. Currently enrolled in interventional randomised controlled trials","21 Years",{"count":404,"type":21},572,[24],"Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers\u002Fpartners playing a significant role in influencing maternal stress and mood symptoms.\n\nThis goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.\n\nExpecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.\n\nParticipants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.",[143,142,408,409,29,410],"Parenting Self-efficacy","Stress (Psychology)","Emotion Regulation",[412,413,410,29,142,143],"Reinforcement Learning","Micro-randomization","2026-06-28",{"date":272,"type":47},{"date":417,"type":21},"2026-07-06",{"date":419,"type":21},"2028-12-31",{"name":421,"class":54},"Institute for Human Development and Potential (IHDP), Singapore",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":76},"100250835","phase-2-neurobiology-of-suicide-100250835","NCT02543983","Neurobiology of Suicide","The Neurobiology of Suicide","* INCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score \\>= 90% on the Baseline consent quiz\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n4. Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Patients must have completed Study Phase I as a participant in Group 1 or 5\n2. Participants must verify understanding of the protocol by a score \\>= 80% on the Ketamine Response consent quiz.\n3. Patients in Group 1 or 5 must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase.\n\n   * MADRS score of over 10 (10 used as an outcome measure for remission)126\n   * OR HAMA score of over 7 (7 used as an outcome measure for remission)127\n   * OR SSI score of 2 or more (indicates any residual suicidal thoughts)\n4. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase II.\n\nPhase III: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests\u002Fexaminations.\n2. Current drug or alcohol dependence\n3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.\n4. Pregnant or nursing individuals or those who plan to become pregnant.\n5. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.\n6. Clinically significant abnormal laboratory tests.\n7. Positive HIV test\n8. Participants who, in the investigator s judgment, pose a current homicidal risk or pose suicide risk that cannot be managed in a secure, voluntary inpatient setting.\n9. Non-English speakers\n10. Additional Criteria for Group 1 (Active Crisis): For participants who still experience the effects of their suicide attempt, i.e. someone who overdosed is significantly drowsy or confused, the consenting process will occur after the patient has improved from the effects. If there is a concern around a participant's capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is\n\nmonitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. Current or past Axis I diagnosis\n2. Presence of medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or \"substance abuse disorder\" per DSM-V).\n4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.\n5. Pregnant or nursing individuals or those who plan to become pregnant.\n6. No lifetime suicide attempts or ideations\n7. Non-English speakers\n8. Positive HIV test\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II.\n2. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase II.\n3. Subjects with one or more seizures without a clear and resolved etiology\n4. Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.\n5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n6. Pregnant or nursing individuals or those who plan to become pregnant.\n7. A medical finding or condition that in the clinical judgement of the investigator increases the risk of adverse effects from the ketamine administration (for example: findings suggesting difficulties with kidney or cardiac function that may be contraindications for an experimental intervention).\n\nPhase III: Repeated Administration (Group 1) and Group 5 (Suicide Ideators)\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III.\n3. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase III.\n4. Subjects with one or more seizures without a clear and resolved etiology\n5. Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.\n6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n7. Pregnant or nursing individuals or those who plan to become pregnant.\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures",{"count":430,"type":21},325,[432],"PHASE2","Background:\n\nThere are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.\n\nObjective:\n\nTo understand what happens in the brain when someone has thought about or attempted suicide.\n\nEligibility:\n\nGroup 1: Adults ages 18 70 who have thought about or attempted suicide recently\n\nGroup 2: Adults ages 18 70 who have thought about or attempted suicide in the past\n\nGroup 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide\n\nGroup 4: Healthy volunteers the same ages.\n\nDesign:\n\nParticipants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.\n\nPhase 1: 1 week in hospital. Participants will have:\n\nPhysical exam.\n\nQuestions about thoughts and feelings.\n\nThinking and memory tests and simple tasks.\n\nBlood and urine tests.\n\nTwo MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.\n\nSleep test. Disks and bands will be placed on the body to monitor it during sleep.\n\nMagnetic detectors on their head while they perform tasks.\n\nA wrist monitor for activity and sleep.\n\nLumbar puncture (optional). A needle will collect fluid from the back.\n\nShock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.\n\nPhase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.\n\nPhase 3: up to 4 more ketamine doses over 2 weeks.\n\nParticipants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.",[435,29],"Healthy Volunteers",[437,98,438,91,439],"Neurobiology","Ketamine","Biomarkers","2026-06-27",{"date":272,"type":47},{"date":443,"type":47},"2015-12-01",{"date":445,"type":21},"2030-07-21",{"name":229,"class":230},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":83,"sex":17,"minAge":454,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":463,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":106},"100645267","belief-update-the-effects-of-depression-and-antidepressants-in-older-people-100645267","NCT07681492","Belief Update: The Effects of Depression and Antidepressants in Older People","OLDBELIEFS","Inclusion Criteria for patients with major depressive disorder :\n\n* Patient over 65 years old in outpatient care\n* Patients with major depressive disorder or patients with bipolar major depressive disorder as evaluated by the Mini International Neuropsychiatric Interview (MINI) semi-structured interview for the group suffering from depression\n* Absence of cognitive impairment as evidenced by an MMSE (Mini Mental State Examination) ≥ 24\n* MADRS ≥ 20\n* MMSE ≥ 24\n* Change of antidepressants\n* Person affiliated with a social security scheme\n* Patients who have received informed information about the study and have signed a consent form to participate in the study\n\nExclusion Criteria with major depressive disorder :\n\n* mental disorders other than mood disorders : attention deficit dissorder, borderline personality disorder, schizophrenia, autism spectrum disorder, anorexia-bulimia disorder, obsessive-compulsive disorder, anxiety disorders and substance use disorder (except tobacco).\n* Inability to understand task instructions and perform the behavioral task\n* Neurological or neurosurgical comorbidities\n* Major visual impairment\n* Adults under state medical aid\n* Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty\n\nInclusion Criteria for patients with major depressive disorder :\n\n* Absence of psychiatric disorders attested by administration of the MINI\n* Absence of cognitive impairment as evidenced by an MMSE ≥ 24","65 Years",{"count":456,"type":21},62,[24],"People in good health do not perceive the future in the same way as those suffering from depression. This difference in perception affects behaviour and emotions and warrants further investigation, both before and after treatment with antidepressants. Research shows that past negative experiences with medication can reduce the effectiveness of treatment, whilst positive expectations can increase it. It is important to gain a better understanding of how antidepressants influence the way in which elderly people with major depressive disorder (MDD) change their beliefs, and to determine whether an improvement in their depressive symptoms is linked to these changes in their beliefs. This study aims to understand whether antidepressants can alter the way people view the future and whether this contributes to their effectiveness. It also seeks to determine whether patients' expectations regarding treatment influence clinical outcomes, and whether changes in their mood may in turn affect these expectations. The study will involve 31 patients aged 65 and over who are suffering from a depressive disorder and require a change of antidepressant, and 31 healthy subjects, also aged 65 and over. The participants' involvement will last for 12 weeks.\n\nDuring a medical consultation, once the doctor has checked that the participant meet all the study's eligibility criteria, they will ask for the participant consent to take part in the study. The participant will then be asked to answer one question about what you hope to gain from the new antidepressant treatment that the doctor will prescribe for the participant. Finally, the participant will carry out a belief-updating exercise, which involves : presenting the participant with a series of events and ask them to indicate how likely they think each of them is to occur, and then. Once they have received further information about these events, ask them to reassess the likelihood of them occurring. This task will be carried out again 12 weeks after the participant start taking their antidepressant, during a consultation required as part of their individual care plan. From the first week of antidepressant treatment until week 12, the participant will be contacted by telephone once a week to answer two short questions about their expectations regarding the treatment and any changes in your mood.",[460,461,462,29],"Major Depressive Episode (MDE)","Beliefs","Beliefs About Future",[460,461,464,29],"Beliefs about future","2026-06-26",{"date":172,"type":47},{"date":468,"type":47},"2025-01-14",{"date":470,"type":21},"2027-10",{"name":472,"class":54},"Hospital Center Guillaume Régnier",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":480,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":491,"locationsCount":76},"100561509","phase-2-clemastine-for-improving-white-matter-and-boosting-antidepressant-response-in-late-life-depression-100561509","NCT06591091","Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression","CLIMB","Inclusion Criteria:\n\n* Age \\> 60 years\n* Diagnosis of major depressive disorder, single or recurrent episode (DSM5)\n* Symptom Severity: MADRS ≥ 15\n* Seeking antidepressant treatment\n* Cognition score of MoCA \\>24\n* Fluent in English or Spanish\n\nExclusion Criteria:\n\n* Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present uniquely during the depressive episode (e.g., generalized anxiety disorder (GAD) or panic disorder symptoms)\n* History of alcohol or drug dependence or abuse in the last year\n* History of a developmental disorder or history of IQ (intelligence quotient) \\\u003C70\n* Acute suicidality ideation within the past month as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Acute grief (\\\u003C1 month)\n* Current or past psychosis\n* Primary neurological disorder, including dementia, clinical stroke, brain tumor, epilepsy, etc.\n* Presence of unstable medical illness requiring urgent treatment\n* Any MRI contraindication\n* Electroconvulsive Therapy (ECT) in last 6 months","60 Years",{"count":166,"type":21},[432],"The goal of this study is to find out if the antihistamine, clemastine, can make the white matter in the brain better in older adults with depression. The study will also determine whether this improvement can make antidepressant treatment work better, reduce depressive symptoms, and improve memory and thinking.",[29],[486,487],"Late-life Depression","Antidepressant medication response",{"date":272,"type":47},{"date":364,"type":47},{"date":124,"type":21},{"name":492,"class":54},"University of Illinois at Chicago",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":454,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":76},"100601507","feasibility-of-home-based-intermittent-60hz-light-therapy-for-major-depressive-disorder-mdd-100601507","NCT07111390","Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)","A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression","Inclusion Criteria:\n\n* Age between 24 and 65 years (inclusive)\\*.\n* Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview.\n* Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening.\n* On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening.\n* No evidence of premorbid cognitive impairment, as demonstrated by a standard score \\>85 on the WRAT-5 Reading Recognition Subtest.\n* Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms.\n* Able to provide informed consent and comply with study procedures.\n* Access to a quiet space suitable for home-based light stimulation sessions.\n* English speaking: All study materials and assessments are only validated in English\n\nExclusion Criteria:\n\n* Presence of primary neurological or autoimmune disorders.\n* Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder).\n* Current or recent diagnosis of alcohol or substance use disorder.\n* History of bipolar disorder or any psychotic disorder.\n* Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).\n* History of seizure disorder or epilepsy.\n* History of migraine, tinnitus, or photosensitivity.\n* Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure.\n* Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).\n* Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding",{"count":501,"type":21},40,[24],"This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.",[29,94,91,505],"Major Depressive Episode",[507,94,29,508,509,510,511],"Brain stimulation","Light therapy","Wearable","Neuromodulation","Telehealth","2026-06-25",{"date":361,"type":47},{"date":515,"type":47},"2025-08-18",{"date":517,"type":21},"2027-02-01",{"name":519,"class":54},"NYU Langone Health",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":454,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":76},"100585386","phase-2-home-based-transcranial-direct-current-stimulation-tdcs-for-depression-in-multiple-sclerosis-ms-100585386","NCT06901687","Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)","Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial","Inclusion Criteria:\n\n* Age: 18-65 years (inclusive)\n* Diagnosis: Confirmed diagnosis of multiple sclerosis (MS), including relapsing-remitting or secondary progressive subtypes\n* Stable Medications: Stable use of antidepressant and disease-modifying therapies (DMTs) for at least 30 days prior to enrollment\n* Stable Disease Activity: Defined as no clinical relapse, no new radiological disease activity, and no recent steroid treatment for at least 30 days prior to enrollment\n* Provider Contact: Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms\n* Technical Ability: Ability to use mobile devices and participate in remote, video-supervised sessions\n\nExclusion Criteria:\n\n* Neurological or Medical Disorders: History of primary neurological disorder other than MS (e.g., stroke, Parkinson's disease, traumatic brain injury (TBI), intracranial mass, epilepsy, mild cognitive impairment (MCI), dementia), major psychiatric disorders (e.g., bipolar disorder, psychotic disorders), or serious medical conditions (e.g., myocardial infarction, thyroid disease, diabetes with complications, atrial fibrillation)\n* Substance Use: Nicotine use (e.g., smoking or vaping) within the past 6 months\n* Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding. If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.\n* Seizure History: History of seizures or seizure disorder within the past 5 years\n* Implanted Devices or Metal Objects: Presence of metal in the head\u002Fneck area (excluding dental fillings) or implanted medical devices (e.g., neurostimulators, pacemakers, defibrillators)\n* Skin Conditions: Active skin disorders or skin sensitivity near electrode application sites",{"count":528,"type":21},170,[432],"This project is a double-blind, sham-controlled, parallel-arm, randomized controlled trial. We will recruit n=170 people living with MS, who are experiencing an episode of depression in the context of a major depressive episode (MDE). Using our remotely supervised (RS) tDCS protocol, enrolled participants will complete 30 days of 30-minute tDCS (2.0, DLPFC left anodal) while listening to mindfulness meditation. Over the course of the study, participants will complete assessments of depression and MS symptoms. Participants will be randomized 1:1 active:sham tDCS.",[532,29],"Multiple Sclerosis",[532,29,510,534,535],"Home-Based","transcranial direct current stimulation",{"date":361,"type":47},{"date":538,"type":47},"2025-08-11",{"date":540,"type":21},"2028-06-01",{"name":519,"class":54},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":549,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":271,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":76},"100639756","phase-2-the-efficacy-of-psilocybin-therapy-for-depression-in-parkinsons-disease-100639756","NCT07610369","The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","PSI-PD","Inclusion Criteria:\n\n* Able to understand and provide informed consent\n* Comfortable speaking and writing in English\n* Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an \"on\" phase (time when medication\u002FDBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)\n* Have no changes in medication or major surgical procedures anticipated for treatment duration\n* Have a score \\>\u002F=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline.\n* For people who can become pregnant: agree to use highly effective contraception from entry into the trial through Day B30 assessments (4 weeks after the second psilocybin administration session) and agree to not breastfeed. Acceptable methods of contraception are: An intrauterine device (IUD), hormone-based contraceptives (birth control pills) , condoms (internal or external) must be used with another method (other than spermicide), and complete abstinence from sexual activity that could result in pregnancy.\n* Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and assessed for safety. Agree to abstain from all tobacco and nicotine use for the duration of the study.\n* Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions.\n* Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree not to use products or substances containing Δ9-tetrahydrocannabinol (THC) and\u002For cannabidiol for at least 7 days prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to not use non-prescribed narcotics (eg. heroine, fentanyl), depressants (eg. Barbiturates, benzodiazepines) and\u002For inhalants for the duration of participation in the trial.\n* Agree not to consume alcoholic beverages for at least 24 hours prior to and 24 hours following each psilocybin administration session.\n* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating care and is available for consultation with the study medical monitor.\n\nExclusion Criteria:\n\n* Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.\n* Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \\\u003C24.\n* Symptomatic orthostatic hypotension.\n* Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and\u002For TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.\n* Treatment in a clinical trial within 30 days of entry into this trial or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, prior to entry into this trial.\n* Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial.\n* Current severity of psychiatric symptoms warranting immediate treatment as determined by the study medical staff (e.g. due to inability to provide for basic needs\u002Fsafety). The study medical staff will assess these individuals, determine the appropriate level of care, and coordinate with the individual's primary providers to ensure close follow-up.\n* High risk of self-harm\u002Fsuicide, as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) risk screen, specifically: participant answers \"yes\" to item 4 or 5 suggesting intent to act on suicidal thoughts OR participant has made a serious suicide attempt within the 12 months prior to entry into this trial.\n* History of meeting DSM-5 criteria for a schizophrenia spectrum disorder, other psychotic disorder, or a mood disorder with psychotic features.\n* History of delusional symptoms or any other psychotic symptoms accompanied by a loss of insight. Exceptions may be made at the investigators' discretion in cases of a history of psychotic symptoms that were attributable to substance or medication use.\n* Current delusional symptoms or any other psychotic symptoms accompanied by a loss of insight.\n* History of a schizophrenia spectrum disorder in a first-degree relative.\n* History of bipolar disorder 1 in a first-degree relative, in whom illness onset was prior to age 40.\n* Current or history of meeting DSM-5 criteria for a bipolar disorder.\n* Current or history within the last 2 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder, excluding caffeine.\n* Currently meeting DSM-5 criteria for another psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin treatment procedures as determined by the investigators.\n* History of meeting DSM-5 criteria for Hallucinogen Persisting Perception Disorder (HPPD).\n* History of using any psychedelic substances including psilocybin, lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 2C compounds, 3,4-methylenedioxy-methamphetamine (MDMA), or methylone during the past 6 months at dosages and\u002For frequencies determined clinically significant by the investigators.\n* Cancer with known central nervous system (CNS) involvement, CNS infection, or other major CNS disease aside from PD.\n* Epilepsy or other seizure disorder in adulthood.\n* Supplemental oxygen requirement.\n* Allergy or intolerance to any of the materials contained in the drug products.\n* Renal insufficiency defined as creatinine clearance \\\u003C 40 ml\u002Fmin using Cockraft and Gault equation\n* Insufficiently managed endocrine conditions, including diabetes mellitus and clinically significant thyroid dysfunction.\n* Cardiovascular conditions, including:\n\n  * Elevated blood pressure defined as systolic blood pressure (SBP) \\>150 or diastolic blood pressure (DBP) \\>95 taken during Enrollment\n  * Tachycardia defined as heart rate (HR) \\>90 beats per minute taken during Enrollment\n  * Bradycardia defined as HR \\\u003C50 bpm taken during Enrollment\n  * Angina\n  * History of stroke within the past year\n  * Clinically significant ECG abnormality as determined by the investigators, including but not limited to QTc \\> 450\n* Hepatic dysfunction as indicated by any of the following laboratory values:\n\n  * AST \\> 3 x upper limit of normal\n  * ALT \\> 3 x upper limit of normal\n  * Total bilirubin \\> 3.0 mg\u002Fdl\n* Use of any of the following concomitant medications AND inability\u002Funwillingness to discontinue for at least 5 times the elimination half-life of the agent (specific exceptions are noted) prior to psilocybin administration, including:\n\n  * Agents that may be associated with serotonin syndrome:\n\n    * MAO inhibitors (participants must have discontinued 2 weeks prior to baseline)\n    * St. John's Wort\n    * S-adenosyl-methionine (SAM-e)\n    * 5-Hydroxytryptophan (5-HTP)\n    * Dextromethorphan\n    * Opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)\n    * Lithium\n    * Linezolid\n    * Buspirone\n  * Agents that may interact with psilocybin metabolism\u002Feffects:\n\n    * Serotonin antagonists (e.g., cyclobenzaprine, ondansetron)\n    * Antipsychotics\n    * Other dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine)\n    * Nicotine\n    * Modulators of uridine diphosphate (UDP) or glucuronosyltransferase (UGT) (e.g. valproate, diclofenac, mefenamic acid, verapamil, ketoconazole, itraconazole, probenecid, phenobarbital, protease inhibitors)\n    * L-methyl folate (\\>\u002F= 7.5mg\u002Fday)\n    * Efavirenz\n  * Agents that may increase the risk of psychotic symptoms:\n\n    * Stimulants (e.g. modafinil, methylphenidate, atomoxetine, methamphetamine, cocaine, amphetamine derivatives)\n    * Anticholinergics (e.g. benztropine, trihexyphenidyl, scopolamine, hyoscyamine)\n    * Systemic steroids\n  * Tricyclic antidepressants\n* Other medical condition or diagnosis, concomitant medication(s), physical exam finding, laboratory abnormality or health risk identified that precludes participation in study procedures due to safety or feasibility concerns at the discretion of the investigators.","40 Years","80 Years",{"count":501,"type":21},[432],"The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.",[29,555],"Parkinson's Disease (PD)",[557,29,359,558,559],"Parkinson's Diesease","Psilocybin therapy","Movement disorder","2026-06-24",{"date":361,"type":47},{"date":563,"type":21},"2026-06",{"date":565,"type":21},"2030-06",{"name":567,"class":54},"Yale University",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":22,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":76},"100474101","the-neural-underpinnings-of-depression-and-cannabis-use-in-young-people-living-with-hiv-100474101","NCT05453513","The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV","Inclusion Criteria:\n\n* HIV seropositivity confirmed with lab report, medical records, or HIV testing.\n* Between the ages of 18-39 years\n* Fluency in English or Spanish\n* Ability to provide informed consent and perform study procedures, including estimated full-scale intelligence quotient (IQ) \\>75 to ensure that participants are able to understand the study.\n* Cannabis users: To capture a wide range of cannabis use frequency, meeting Diagnostic and Statistical Manual 5 (DSM-5) criteria for Cannabis use Disorder (CUD) will not be required. However, in order to ensure sufficient exposure, cannabis use will be significant (self-reported use on ≥20 of the prior 30 days and positive THC urine toxicology).\n* Depressed: In order to capture a wide range of depression illness severity, we will allow participants with subthreshold depression, defined as a raw severity score of ≥12 on the Montgomery Asberg Depression Rating Scale (MADRS).\n\nExclusion Criteria:\n\n* Perinatally acquired HIV infection, as early neurodevelopmental alterations and HIV legacy effects may exist in this group\n* Pregnancy or lactation\n* Current Substance Use Disorder other than cannabis or nicotine\n* Certified for or self-reported medical cannabis use, or intent to become certified\n* Current cocaine use by self-report or urine toxicology\n* central nervous system (CNS) disease or injury, or neuro-degenerative disease\n* Unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis);\n* Severe medical illness such as end-stage renal disease, heart failure, cirrhosis, or cancer\n* MRI contraindication such as claustrophobia, metallic ink tattoos, or pacemaker.\n\nDepressed cannabis non-users:\n\n* At baseline, all participants will be psychotropic-medication-free for ≥1 month prior to study enrollment (or ≥3 months for medications with longer half-lives). Benzodiazepines and sleeping aids taken on an as-needed basis will be allowed, however we will require a 4-day abstinence period before the scan.\n* Exclusionary are participants with a DSM-5 diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and all non-cannabis substance-related disorders will be exclusionary. disorder (PTSD) are not uncommon among depressed individuals and will be\n* Anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress are allowed as long as depressive symptoms are primary.\n\natypical of depression. • Suicidal ideations (SI) without a specific plan (defined as passive SI) are common in depression and will be allowed. However, if SI constitutes an imminent risk to self or others (defined as active SI), the participant will be withdrawn from the study and emergency procedures will be initiated immediately, including ER admission.\n\nDepressed cannabis users:\n\n• Exclusion criteria will be the same as depressed cannabis non-users except for cannabis use.\n\nNon-depressed cannabis users:\n\n• Will have no major psychiatric conditions other than cannabis use\u002Fdisorder.\n\nNon-depressed cannabis non-users:\n\n• Exclusion criteria will be the same as for non-depressed cannabis users; in addition participants will not report cannabis use in the prior 90 days and have a urine toxicology test negative for cannabis.","59 Years",{"count":576,"type":21},280,[24],"To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the study team seeks to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study team proposes a tightly integrative study to test the overall hypothesis that cannabis use and depression in young PLWH have an additive effect, inducing both reward deficits and pain hypersensitivity, and that this pattern will predict worse outcomes at 1 year follow-up.",[29,580,581],"Cannabis Use Disorder","HIV",{"date":361,"type":47},{"date":584,"type":47},"2022-04-01",{"date":586,"type":21},"2027-07-30",{"name":588,"class":54},"University of Miami",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":612,"locationsCount":614},"100422171","phase-3-a-study-to-assess-change-in-disease-activity-and-adverse-events-aes-with-cariprazine-in-the-treatment-of-depressive-episodes-in-pediatric-participants-participants-10-to-17-years-of-age-with-bipolar-i-disorder-100422171","NCT04777357","A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.","A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder","3112 Ped BPD","Inclusion Criteria:\n\n* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Current depressive episode is more than 2 weeks and less than 12 months in duration.\n* Participant has a lifetime history of at least one manic episode.\n* Children's Depression Rating Scale - Revised (CDRS-R) score \\> = 45 at Visit 1 and Visit 2.\n* Young-Mania Rating Scale (YMRS) score \\\u003C = 12 with YMRS Item 1 (elevated mood) score \\\u003C = 2 at Visit 1 and Visit 2.\n* Clinical Global Impression-Severity (CGI-S) scale score of \\> = 4 (moderately ill) at Visit 1 and Visit 2.\n\nExclusion Criteria:\n\n* Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.\n* Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 1.\n* History of serotonin syndrome or neuroleptic malignant syndrome.\n* Four or more episodes of a mood disturbance within the 12 months before Visit 1.\n* DSM-5 diagnosis of intellectual disability (IQ \\\u003C 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.\n* History of seizures, with the exception of febrile seizures.\n* Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.\n* Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.\n* Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.\n* Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.\n* Treatment with clozapine in a dose of \\>= 50 mg\u002Fd in the past 2 years.\n* History of or any current ocular disease including, but not limited to, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).","17 Years",{"count":599,"type":21},380,[191],"Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.\n\nCariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.\n\nParticipants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[29,603],"Bipolar I Disorder",[29,605,603,606,607],"RGH-188","Vraylar","Cariprazine",{"date":465,"type":47},{"date":610,"type":47},"2021-04-28",{"date":277,"type":21},{"name":613,"class":280},"AbbVie",81,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":83,"sex":17,"minAge":622,"maxAge":289,"enrollmentInfo":623,"targetDuration":4,"studyType":625,"phases":4,"briefSummary":626,"conditions":627,"keywords":631,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":4,"leadSponsor":639,"locationsCount":76},"100059955","evaluation-of-patients-with-mood-and-anxiety-disorders-and-healthy-volunteers-100059955","NCT00024635","Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers","The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers","* INCLUSION CRITERIA:\n* Subjects ages 3 to 99 may enroll in the protocol.\n* Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. Minors will be asked to assent and their parents will sign the consent form.\n\nEXCLUSION CRITERIA:\n\n-Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment, but not including self-help groups).","3 Years",{"count":624,"type":21},16000,"OBSERVATIONAL","The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved ETPB protocols.",[628,629,435,630,29],"Mood Disorders","Anxiety Disorders","Bipolar Disorder",[632,143,633,634,635],"Screening","Mood","Diagnostic Testing","Natural History",{"date":512,"type":47},{"date":638,"type":47},"2001-02-02",{"name":229,"class":230},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":17,"minAge":647,"maxAge":648,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":76},"100623532","cognition-and-behavior-with-sham-accelerated-tms-100623532","NCT07397858","Cognition and Behavior With Sham Accelerated TMS","Studies of Cognition and Behavior Using Sham Accelerated Transcranial Magnetic Stimulation","Inclusion Criteria:\n\n* English speaking\n* Able to provide informed consent (and assent if \\\u003C 18 years)\n* 15-25 years old\n* Slight-to-severe symptoms of depression\n\nExclusion Criteria:\n\n* Past exposure to Transcranial Magnetic Stimulation\n* Unable to consent (due to medical condition, psychosis, substance use, etc)\n* Acute suicidal crisis or with active medical illness that would interfere with participation\n* Contraindications to receiving MRI as determined by screening questionnaires (Contraindications for MRI include metal in the body related to an injury or surgery, for example, surgical clips, metal fragments in the eyes, or piercings that cannot be removed. Subjects with braces or permanent retainers will not be scanned, because the effects on image signal are not well understood and may affect comparability between subjects and scan sites. Participants will be excluded for major neurological problems, such as seizure disorder, traumatic brain injury with loss of consciousness, or sensory problems that may impair task performance, such as blindness.)\n* Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies","15 Years","25 Years",{"count":7,"type":21},[24],"The goal of this clinical study is to understand how a person's expectations about treatment can influence their mood, motivation, and reactions to everyday rewards. The study includes young people ages 15-25 who will complete a sham (placebo) version of an accelerated transcranial magnetic stimulation (TMS) treatment. No active brain stimulation is given.\n\nThe main questions this study aims to answer are:\n\n1. Do expectancy and treatment beliefs change during and after an accelerated sham TMS schedule?\n2. Do these expectations influence mood, reward processing, or craving?\n3. Does a more intensive schedule of sham sessions lead to different expectancy effects than a slower, once-daily schedule?\n\nParticipants will:\n\n* Complete baseline clinical assessments and an MRI session\n* Undergo five days of accelerated sham TMS (no active brain stimulation is delivered)\n* Complete post-treatment MRI and follow-up assessments at 1 week and 4 weeks",[29],[654,655],"TMS","Sham TMS","2026-06-23",{"date":465,"type":47},{"date":659,"type":47},"2026-04-11",{"date":661,"type":21},"2028-01",{"name":663,"class":54},"University of California, Davis"]