[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mclean Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":614},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,42,75,101,122,145,172,194,211,236,255,277,310,335,356,375,398,423,448,468,490,517,551,575,593],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100529436","mechanisms-of-exposure-therapy-for-ocd-100529436",false,"NCT06173752","Mechanisms of Exposure Therapy for OCD","Leveraging Machine Learning Approaches to Understand Mechanisms of Exposure Therapy in Real-World Settings","Inclusion Criteria:\n\n* Between the ages of 18-65 years old\n* Seeking exposure treatment at McLean Hospital OCD Institute or San Diego State University\n* Have a diagnosis of OCD\n* Able to complete study measures and treatment procedures in English\n\nExclusion Criteria:\n\n* Acute symptoms of psychosis\n* Active suicidality (plan, means, intent and\u002For suicide attempt in past 3 months)\n* Presence of co-occurring symptoms that warrant higher level of care (e.g., inpatient treatment)\n* Presence of any medical, psychiatric, or developmental condition that would prevent patients from completing assessments or exposure exercises (e.g., non-verbal autism spectrum disorder)","ALL","18 Years","65 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"NA","Exposure therapy is the most effective treatment available for obsessive compulsive disorder, yet up to 50% of patients do not recover because the mechanisms underlying successful response are poorly understood, leading to significant variability in how clinicians conduct exposure therapy. The main purpose of this study is to determine which target mechanisms are most critical to engage in real-world exposure sessions to produce good treatment outcomes. Adult participants (N = 400) with Obsessive Compulsive Disorder (OCD) receiving exposure therapy from two sites (McLean Hospital, San Diego State University) across the continuum of care (outpatient, partial hospital, residential) will complete baseline clinical and demographic measures as well as weekly symptom reports. The project will measure exposure mechanisms across three levels of analysis (self-report, observer-rated behavior, physiology) during each exposure session. Mechanisms assessed will include a broad range of variables based on both habituation and inhibitory learning models of exposure. Self-report and observer-rated mechanisms will be measured with the Exposure Feedback Form, created and piloted by the study team. Physiological mechanisms will include skin conductance response, heart rate, and heart rate variability measured with a wristwatch. The current study will determine (1) which exposure mechanisms lead to favorable clinical outcomes, and (2) what makes a good exposure for whom. Results of this study have the potential to improve personalized care for the many patients who do not remit following exposure therapy for OCD.",[28],"Obsessive-Compulsive Disorder","RECRUITING","2026-06-24",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2024-10-16",{"date":37,"type":22},"2029-04",{"name":39,"class":40},"Mclean Hospital","OTHER",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100631623","pilot-study-of-sensor-informed-smartphone-based-mental-health-interventions-for-mood-in-early-psychosis-100631623","NCT07503093","Pilot Study of Sensor-Informed Smartphone-based Mental Health Interventions for Mood in Early Psychosis","Development of Sensor-Informed Smartphone-Based Mental Health Intervention for Early Psychosis","Inclusion Criteria:\n\n* Age 18-50 years\n* History of DSM-5 psychotic disorder (e.g., schizophrenia, schizoaffective disorder, psychosis not otherwise specified)\n* Current elevated mood symptoms, defined as mild or greater depressive symptoms (Patient Health Questionnaire-8 score ≥5) or anxiety symptoms (Generalized Anxiety Disorder-7 score ≥5)\n* Own a personal iPhone or Android smartphone\n* Willing and able to provide informed consent\n* English-speaking\n\nExclusion Criteria:\n\n* Active suicidal ideation with both intent and a specific plan.\n* Current substance use disorder requiring acute treatment\n* Diagnosis of neurodevelopmental disorder that would impair ability to use smartphone app or complete study procedures\n* Traumatic brain injury with significant cognitive impairment","50 Years",{"count":51,"type":22},10,[25],"The aim of this trial is to evaluate the feasibility and preliminary efficacy of using passive smartphone sensors to detect moments of heightened negative mood and inform the timing of brief mental health interventions, such as mindfulness exercises and psychoeducation, in adults with early psychosis.",[55,56,57,58],"Psychosis","Anxiety","Depression","Rumination",[60,61,55,62,63,64,65],"Mirco-Randomized Study","Mobile Health","Digital Mental Health","Negative Mood","Digital Phenotyping","Passive Sensors","NOT_YET_RECRUITING","2026-06-22",{"date":32,"type":33},{"date":70,"type":22},"2026-08-01",{"date":72,"type":22},"2027-06-01",{"name":39,"class":40},1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":74},"100503580","phase-2-efficacy-and-safety-of-magnesium-vitamin-b6-in-first-episode-bipolar-disorder-100503580","NCT05837104","Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder","Inclusion Criteria:\n\n* Persons between the ages of 18 and 50\n* DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years\n* Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.\n* Young Mania Rating Scale (YMRS) scores of less than 15\n* Ability to sign informed consent.\n* Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent.\n* Persons weighing over 350lbs.\n* Declines to participate.\n* Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.\n* 2 or more manic symptoms that meet DSM-V criteria.\n* Persons of childbearing potential who are not using a medically accepted means of contraception.\n* Persons who are deemed a serious suicide or homicide risk.\n* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.\n* The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder.\n* Persons meeting criteria for bipolar mixed episode.\n* Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.\n* Severe hypomagnesemia (serum magnesium of 0.45 mmol\u002FL).\n* Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.\n* Seizure disorder.\n* Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.\n* Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.\n* Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months.\n* Have any medical condition that would prevent blood draws.\n* Have a history of significant head injury.\n* Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n* Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6\n* Patients taking psychostimulant medication",{"count":83,"type":22},40,[85],"PHASE2","This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.",[88,89,90],"Bipolar I Disorder","Depression, Anxiety","Stress",[92,93,94,57,56,90],"First episode Bipolar Disorder","Magnesium vitamin B6","Brain energy metabolism",{"date":32,"type":33},{"date":97,"type":33},"2023-12-13",{"date":99,"type":22},"2026-10",{"name":39,"class":40},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":17,"minAge":108,"maxAge":18,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":74},"100416077","mechanisms-and-predictors-of-change-in-app-based-mindfulness-training-for-adolescents-100416077","NCT04697966","Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents","Inclusion Criteria:\n\n* Both genders, all ethnicities (see Section: Inclusion of Women and Minorities)\n* Ages 13-18 years\n* Written informed assent\u002Fconsent from adolescent and parent\u002Fguardian\n* English as a first language or English fluency\n* Right-handed\n* Personal iPhone or Android smartphone\n* CRSQ rumination subscale score\n* If on psychotropic medication, must be on stable dose for at least 2 months\n\nExclusion Criteria:\n\n* History or current diagnosis of any of the following DSM-5 disorders: schizophrenia spectrum or other psychotic disorder, bipolar disorder, substance\u002Falcohol use disorder within the past 12 months or lifetime severe substance\u002Falcohol use disorder.\n* Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow\n* Failure to meet standard exclusion criteria for fMRI scanning (e.g. pregnancy, claustrophobia, cardiac or neural pacemakers, surgically implanted metal devices, cochlear implants, metal objects in the body)\n* History of seizure disorder, or head trauma with loss of consciousness \\> 2 mins\n* Serious or unstable medical illness (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease)\n* Participants with active suicidal ideation will be immediately referred to appropriate clinical treatment.\n* Current or past treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT or ACT)\n* Exposure to in-person or app-based mindfulness\u002Fmeditation course (at least 300 mins of past practice)",true,"13 Years",{"count":110,"type":22},158,[25],"A growing body of research implicates rumination as being a transdiagnostic risk factor involved in the development of depression and anxiety in youth. Critically, mindfulness meditation has shown significant promise in targeting rumination, and ultimately improving depressive and anxiety symptoms. Mindfulness apps offer a convenient and cost-effective means for accessing mindfulness training, while being interactive and engaging for youth. Despite their growing popularity among teens, strikingly little research has been conducted on these apps. Two critical questions have yet to be addressed: (1) what are the underlying neural and cognitive mechanisms that account for the beneficial effects of these apps and (2) for whom is app-based mindfulness well-suited. To address these gaps, adolescents (ages 13-18) will be randomly assigned to an app-delivered mindfulness course vs. a control condition and will complete pre- and post-intervention resting state functional magnetic resonance imaging (fMRI) scans to probe static and dynamic functional connectivity within - and between - brain networks strongly implicated in mindfulness training and rumination. In addition, cognitive tasks will be administered at pre- and post-intervention to assess attentional control abilities putatively enhanced by mindfulness training. Finally, mindfulness skills and changes in rumination will be assessed via smartphone-based ecological momentary assessment (EMA). First, the investigators will test whether changes in (1) brain functional connectivity, (2) attentional control and (3) acquisition and use of mindfulness skills mediate between-group (i.e., app vs. control) differences in the reduction of rumination. Second, the investigators will test whether a machine learning model incorporating baseline clinical, demographic, and psychosocial characteristics can be used to identify which adolescents are predicted to benefit from app-based mindfulness training.",[58],"2026-06-15",{"date":116,"type":33},"2026-06-17",{"date":118,"type":33},"2021-11-16",{"date":120,"type":22},"2027-09-30",{"name":39,"class":40},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":23,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":74},"100628385","phase-1-a-pilot-trial-of-one-day-accelerated-tms-and-d-cycloserine-in-suicidal-patients-with-borderline-personality-disorder-100628385","NCT07460947","A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder","A Pilot Trial of One Day Accelerated Intermittent Theta-burst Stimulation Plus D-cycloserine in Suicidal Patients With Borderline Personality Disorder (ONE-D BPD)","ONE-D BPD","Inclusion Criteria:\n\n* Adult (18+) of any gender\n* Meets DSM-5 criteria for BPD, per assessment with the Structured Clinic Interview for DSM-5 Personality Disorders (SCID-5-PD), BPD Module\n* Moderate to severe SI during the two weeks prior to screening, as indexed by a score of 9 or higher on the Modified Scale for Suicide Ideation - Self Report (Clum \\& Yang, 1995)\n\nExclusion Criteria:\n\n* Current manic or hypomanic symptoms, as assessed by the Diagnostic Assessment Research Tool (DART) screener and diagnostic modules, where relevant.\n* Current clinically significant psychotic symptoms not better accounted for by BPD, as assessed by the DART psychotic symptoms screener.\n* Current alcohol or substance use disorder, that in the opinion of a study PIs, is of sufficient severity to impede engagement in treatment or is associated with significant risk of medical withdrawal, as assessed by the DART.\n* Medical documentation or self-report of current anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified - atypical anorexia nervosa or atypical bulimia nervosa, that is in the opinion of a study PIs is of sufficient severity to be associated with significant medical risks\n* Acute suicide risk, sufficient to require immediate hospitalization;\n* history of traumatic brain injury (TBI) or concussion involving loss of consciousness or amnesia for ≥24 hours;\n* any significant neurological disorder likely to be associated with increased intracranial pressure or cognitive impairment (e.g., epilepsy; Parkinson's disease);\n* diagnosed neurodevelopmental disorder (e.g., autism, downs syndrome; Ehlers-Danlos Syndrome) other than attention-deficit hyperactivity disorder (ADHD) or dyslexia\n* current diagnosis of delirium or dementia;\n* cognitive disorder secondary to a general medical condition\n* Pregnant and breastfeeding people are excluded in line with the studies our protocol is based upon using DCS and aTMS. Assessment of pregnancy will be completed during the 1-week prior to the administration of DCS (i.e., taken the night before TMS treatment), where relevant and according to MGB IRB policy.\n* Participants with contraindications to TMS (e.g., metal in head or neck area), or at increased risk for adverse events (e.g., seizure history or markedly heightened risk factors for seizures, serious medical problems, implanted devices) will be excluded.\n* Participants with a known allergy to DCS will be excluded from the study.\n* No patients with involuntary hospitalization status will be recruited for the study.\n* No individuals who are not proficient in English will be recruited for the study\n* Subject does not have a PCP",{"count":131,"type":22},20,[133,85],"PHASE1","This study tests a new treatment for people with borderline personality disorder (BPD). The treatment combines a medication called D-cycloserine with one day of transcranial magnetic stimulation (TMS).\n\nThe main questions it aims to answer are:\n\n* How many participants complete the treatment?\n* How do participants feel about the treatment?\n* Does the treatment have neurophysiological changes on participants?\n* Does the treatment improve BPD symptoms?\n* Do the benefits last over time?\n\nParticipants will be asked to:\n\n* Come to the clinic for interviews and testing\n* Complete weekly questionnaires for 4 weeks before the treatment day\n* Take D-cycloserine the night before treatment\n* Attend one treatment day at the clinic. On that day, they may receive up to 20 short TMS sessions (each lasting 3 minutes and separated by 30 minutes). This visit may last up to 12 hours.\n* Complete weekly questionnaires for 6 weeks after the treatment day.",[136],"Borderline Personality Disorder (BPD)","2026-06-02",{"date":139,"type":33},"2026-06-04",{"date":141,"type":22},"2026-06-09",{"date":143,"type":22},"2027-12",{"name":39,"class":40},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":107,"sex":151,"minAge":152,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":74},"100423029","neural-correlates-of-stress-and-perceived-control-in-adolescent-depression-100423029","NCT04788524","Neural Correlates of Stress and Perceived Control in Adolescent Depression","Inclusion Criteria:\n\n* Inclusion Criteria: All Participants\n\n  1. Females of all ethnic origins See Section: Inclusion of Women and Minorities);\n  2. Ages 14-18 (See Section: Inclusion of Children);\n  3. Written informed assent\u002Fconsent from adolescent and parent\u002Fguardian (if under age 18);\n  4. English as a first language or English fluency;\n  5. Right handed111;\n  6. Personal cell-phone (for Ecological Momentary Assessment \\[EMA\\]) 7 All participants will be in the follicular phase of their menstrual cycle when completing the functional magnetic resonance imaging (fMRI) study session\n\nInclusion Criteria: MDD Sample\n\n1. Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS)\n2. Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants);\n\nInclusion Criteria: Healthy Control (HC) Sample\n\n1. No history or current diagnosis of any DSM-5 psychiatric or substance\u002Falcohol-related disorder (as diagnosed with the KSADS)\n2. No first-degree relatives with a history of depression, bipolar disorder, or psychosis\n\nExclusion Criteria:\n\n* Exclusion Criteria: All Participants\n\n  1. History of head trauma with loss of consciousness;\n  2. History of seizure disorder;\n  3. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;\n  4. History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine);\n  5. History of use of dopaminergic drugs (including methylphenidate);\n  6. Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception;\n  7. Clinical or laboratory evidence of hypothyroidism;\n  8. Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow;\n  9. Failure to meet standard exclusion criteria for fMRI scanning (e.g., claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other metal objects in the body);\n  10. Pregnancy\n  11. Testing positive on a drug test on the day of the scan which testis for stimulants, marijuana, barbiturates, benzodiazepine, buprenorphine, 3,4-Methyl enedioxy methamphetamine (MDMA), methadone, opiates, oxycodone, phencyclidine;\n  12. History of electroconvulsive therapy\n  13. Participants with suicidal ideation where study participation is deemed unsafe by the study clinician;\n\nAdditional Exclusion Criteria: Major Depressive Disorder (MDD) Sample\n\n1\\. Major depressive disorder diagnosis secondary to another disorder (selected comorbid anxiety disorders such as generalized anxiety disorder, specific phobia, and social anxiety disorders are allowed if they are secondary to MDD)","FEMALE","14 Years",{"count":154,"type":22},80,[25],"Lack of perceived control, particularly during stress, has been critically implicated in major depressive disorder (MDD) and anhedonic symptoms, especially among female adolescents; yet the neural underpinnings of perceived control disruptions in MDD remain poorly understood. Using functional magnetic resonance imaging with a novel \"value of control task\" in conjunction with a prospective design, this study will provide a comprehensive understanding of stress and perceived control related mechanisms in female adolescents with MDD and will examine stress-induced disruptions in perceived control as a predictor of \"real world\" expressions of maladaptive coping and anhedonia.",[158],"Major Depressive Disorder",[160,161,162,163],"stress","perceived control","neuroimaging","depression","2026-05-18",{"date":166,"type":33},"2026-05-19",{"date":168,"type":33},"2021-04-23",{"date":170,"type":22},"2026-10-31",{"name":39,"class":40},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":107,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":74},"100457087","phase-2-pharmaco-neuroimaging-studies-of-approachavoidance-behaviors-and-post-mortem-studies-pharmacological-manipulation-100457087","NCT05232032","Pharmaco-Neuroimaging Studies of Approach\u002FAvoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation","Pharmaco-Neuroimaging Studies of Approach\u002FAvoidance Behaviors and Post-Mortem Studies: Study 1.1. (Pharmacological Manipulation)","Inclusion criteria for MDD\u002Fanxiety disorder group:\n\n* DSM-5 diagnostic criteria for MDD, Generalized Anxiety Disorder, Social Phobia, Panic Disorder, Post Traumatic Stress (diagnosed using the SCID-5)\n* Written informed consent\n* For MDD subjects, a baseline Hamilton Depression Rating Scale score \\> 16 (17-item version)\n* Right-handed\n* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)\n* Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine, 6 months for neuroleptics, 2 weeks for benzodiazepines, 2 weeks for any other antidepressants)\n\nInclusion criteria for healthy controls:\n\n* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5)\n* Written informed consent\n* Right-handed\n* Absence of any medications for at least 3 weeks\n* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)\n\nExclusion criteria for all participants:\n\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician\n* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception\n* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease\n* History of seizure disorder\n* History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion)\n* History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)\n* History of use of dopaminergic drugs (including methylphenidate)\n* History or current diagnosis of dementia\n* Patients with mood congruent or mood incongruent psychotic features\n* Current use of other psychotropic drugs\n* Clinical or laboratory evidence of hypothyroidism\n* Patients with a lifetime history of electroconvulsive therapy\n* Failure to meet standard magnetic resonance imaging safety requirements\n* Abnormal ECG and lab results\n* History of seizure disorder or currently on anticonvulsants","45 Years",{"count":181,"type":22},112,[85],"The study will investigate whether a nociceptin receptor antagonist will normalize neural and behavioral processes of approach\u002Favoidance decision-making in unmedicated individuals with major depressive disorder (MDD) and anxiety disorders. More specifically, the study aims to investigate dysregulation within (1) corticostriatal-midbrain circuitry and (2) nociceptin\u002Forphanin FQ peptide and the nociceptin receptor (NOPR).",[185,186],"Depressive Disorder, Major","Anxiety Disorder","2026-05-15",{"date":164,"type":33},{"date":190,"type":33},"2025-02-01",{"date":192,"type":22},"2027-03-31",{"name":39,"class":40},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":74},"100456501","interpretation-bias-as-a-mechanism-of-treatment-response-in-ocd-100456501","NCT05224414","Interpretation Bias as a Mechanism of Treatment Response in OCD","Inclusion Criteria:\n\n* 1\\) OCD Institute patients\n* 2\\) adults (\\> 18 years old)\n* 3\\) able to complete a computer task for 20 minutes\n* 4\\) consent to main OCD Institute study protocol\n* 5\\) primary diagnosis of OCD (as measured by a score of \\>16 on the Y-BOCS and a clinical diagnosis of OCD by their treatment team\n* 6\\) score of \\>131 on the Obsessive Beliefs Questionnaire-44 at admission \\[which is 1 SD above the mean score of the non-clinical sample reported in the original validation paper by the Obsessive Compulsive Cognitions Working Group (2005)\\]\n\nExclusion Criteria:\n\n* 1\\) Currently experiencing acute symptoms of psychosis\n* 2\\) Psychotic disorder diagnosis",{"count":201,"type":22},106,[25],"This study will conduct a randomized controlled trial of Cognitive Bias Modification for Interpretation (CBM-I) as an augmentation to treatment as usual for obsessive compulsive disorder (OCD). CBM-I is a digital intervention designed to directly manipulate interpretation bias through repeated practice on a training task, thereby inducing cognitive changes in a relatively automatic or implicit manner. Specifically, this study will examine the feasibility, acceptability, and clinical outcomes associated with CBM-I.\n\nAdults with obsessive compulsive disorder (OCD) will be recruited from a treatment program for this disorder and participants will be randomly assigned to either receive: 1) up to 12 sessions of CBM-I, or or up to 12 sessions of psychoeducation as a control condition.",[28],{"date":164,"type":33},{"date":207,"type":33},"2022-03-30",{"date":209,"type":22},"2026-08-31",{"name":39,"class":40},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":107,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":74},"100637968","phase-1-synaptic-mechanisms-of-intermittent-theta-burst-stimulation-for-major-depressive-disorder-100637968","NCT07593222","Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder","Inclusion Criteria:\n\n* Can safely receive TMS and study drugs\n* Stable medication regimen for one month prior to study participation, and for the duration of the study\n* Not currently receiving TMS, ECT, or ketamine\n* No active safety concerns related to suicidality\n\nExclusion Criteria:\n\n* History of seizures or epilepsy\n* History of intracranial pathology or lesions from any etiology\n* History of traumatic brain injury including prolonged loss of consciousness more than 15 min\n* Signs of increased intracranial pressure\n* Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.)\n* Major medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Severe migraines that may result in treatment intolerance.\n* Inability to tolerate MRI.\n* Pregnancy\n* Known allergic reaction to d-cycloserine or dextromenthorphan",{"count":218,"type":22},100,[133,85],"Many people with depression do not get better with standard treatments like medications or talk therapy. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation treatment that uses magnetic pulses to stimulate areas of the brain involved in depression. One form of TMS called intermittent theta burst stimulation (iTBS) is FDA-cleared for depression and takes only 3 minutes to deliver. However, about one-third of patients do not respond to iTBS, and another one-third do not reach full remission. Improving iTBS requires a better understanding of how it works in the brain.\n\niTBS is thought to work by strengthening connections between brain cells, a process called synaptic plasticity. This process depends on a type of brain receptor called the NMDA receptor. Most of what researchers know about how iTBS affects these connections comes from studies of healthy people. It is not known whether iTBS works the same way in the prefrontal cortex - the brain region targeted during depression treatment - or in people who actually have depression.\n\nThis study has two phases.\n\nIn Phase 1, both healthy volunteers and people with depression will complete 4 research visits to test how iTBS changes brain activity in the prefrontal cortex and whether medications that increase or decrease NMDA receptor activity change those effects. Each visit involves active or sham (inactive) iTBS combined with one of three study medications: a placebo (inactive pill), d-cycloserine (a medication that increases NMDA receptor activity), or dextromethorphan (a medication that decreases NMDA receptor activity). Brain activity is measured before and after each TMS session using electroencephalography (EEG), a painless test that records electrical signals from the scalp through a cap placed on the head. All participants also complete a brain MRI before beginning study visits for targeting purposes.\n\nIn Phase 2, participants with depression will be offered a standard clinical course of 30 daily iTBS sessions (Monday through Friday over 6 weeks). Each session is combined with one blinded study medication (placebo, d-cycloserine, or dextromethorphan) taken daily. Brain activity measurements and standard depression and anxiety questionnaires are collected weekly throughout this phase to track how the brain changes over the course of treatment and whether those changes relate to improvements in symptoms.\n\nTogether, the two phases of this study aim to identify the brain mechanism by which iTBS works in people with depression. This knowledge could lead to more effective TMS treatments for people who have not responded to medications or other therapies.",[222,223],"Major Depression","Healthy Participants",[225,163,226,227,228],"TMS","EEG","transcranial magnetic stimulation","pharmacologic augmentation","2026-05-13",{"date":164,"type":33},{"date":232,"type":22},"2026-07-01",{"date":234,"type":22},"2031-06-30",{"name":39,"class":40},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":74},"100583423","phase-1-pharmacologic-augmentation-of-tms-for-depression-with-d-serine-100583423","NCT06876129","Pharmacologic Augmentation of TMS for Depression With D-serine","PAT-DS","Inclusion Criteria:\n\n* Clinical diagnosis of MDD\n* English-speaking\n* Adults aged 18-80\n* Must be able to swallow capsules\n\nRelative contraindications\u002Fpossible exclusion criteria:\n\n* Containing any implanted metal or devices\n* Current or previous seizure history\n* Active substance use that may significantly alter the seizure threshold\n\nAny further safety clearances, and outpatient consultation opinions that are necessitated based on the answers to the screening will be obtained prior to moving forward with the study, as an already established practice within the clinic practice. In addition, any relative contraindications will be further reviewed according to Rossi et al.'s most updated safety guidelines for TMS.\n\nExclusion Criteria:\n\n* Patients with pre-existing renal disease\n* Known allergy to D-serine, or with\n* Patients taking medications with known drug-drug interactions\n* Children\n* Pregnant or breast-feeding women\n\nThe investigators will not include children because prior safety and dosing studies excluded children. Although considered safe for TMS, the investigators will not include pregnant or breast-feeding women on the basis of unknown safety profile of exogenous D-serine for these patients.","80 Years",{"count":245,"type":22},60,[133],"The goal of this study is to test whether combining D-serine with 30 treatments of a) iTBS and b) 18-Hz protocols will enhance clinical outcomes compared to rTMS with placebo (i.e., sugar pill). The investigators hypothesize that NMDA receptor activation via D-serine combined with repeated sessions of rTMS will produce greater clinical outcomes than iTBS with placebo and 18-Hz with placebo.",[57],{"date":187,"type":33},{"date":251,"type":33},"2025-04-01",{"date":253,"type":22},"2027-04-01",{"name":39,"class":40},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":74},"100636068","early-phase-1-synaptic-mechanisms-of-continuous-theta-burst-stimulation-in-depression-100636068","NCT07560878","Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression","SyncT","Inclusion Criteria:\n\n* Can safely receive TMS and study drugs\n* Stable medication regimen for one month prior to study participation, and for the duration of the study\n* Not currently receiving TMS, ECT, or ketamine\n* No active safety concerns related to suicidality\n* Moderate to severe Major Depressive Disorder as indicated by the Patient Health Questionnaire or Quick Inventory of Depressive Symptomatology\n\nExclusion Criteria:\n\n* History of seizures or epilepsy\n* History of intracranial pathology or lesions from any etiology\n* History of traumatic brain injury including prolonged loss of consciousness more than 15 min\n* Signs of increased intracranial pressure\n* Any major neurological conditions (ex: recent stroke, tumor, neurodegenerative disorders, etc.)\n* Major medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Severe migraines that may result in treatment intolerance.\n* Inability to tolerate MRI.\n* Pregnancy\n* Known allergic reaction to d-cycloserine, baclofen, memantine, or lorazepam",{"count":154,"type":22},[264],"EARLY_PHASE1","Many people with depression do not get better with standard treatments like medication. One promising alternative is transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic pulses to stimulate specific brain regions. A particular pattern of TMS called continuous theta-burst stimulation (cTBS) is thought to reduce overactive brain activity in depression, but the investigators do not yet fully understand how it works at the level of brain cells and connections.\n\nThis study aims to determine the biological mechanism by which cTBS changes brain activity in people with depression. Specifically, the investigators are testing two competing ideas: (1) that cTBS works by weakening the connections between brain cells through a process called long-term depression (LTD), which is driven by a chemical messenger system called glutamate; or (2) that cTBS works by increasing the brain's natural \"braking\" system, driven by a different chemical messenger called GABA.\n\nTo test these ideas, participants with depression will receive cTBS along with one of four FDA-approved medications, or placebo, that either boost or block these chemical messenger systems. The investigators will measure changes in brain activity using electroencephalography (EEG) recorded simultaneously with TMS. Specific patterns in the EEG signal, called TMS-evoked potentials (TEPs), act as a window into how different brain cell types are responding to stimulation.\n\nEach participant will complete four study visits, each testing a different drug-TMS combination in random order. One group of participants will test drugs targeting the glutamate system (d-cycloserine and memantine). A second group will test drugs targeting the GABA system (lorazepam and baclofen). All drugs are given as a single oral dose and are commonly used in clinical practice.\n\nUnderstanding exactly how cTBS works at a biological level could open the door to more effective, personalized TMS treatments.",[222],[225,226,268,57,269],"TMS-EEG","Pharmacologic Augmentation","2026-05-08",{"date":229,"type":33},{"date":273,"type":33},"2026-03-11",{"date":275,"type":22},"2030-12",{"name":39,"class":40},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":107,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":296,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100632905","recovery-inspired-support-engagement-rise-pilot-100632905","NCT07519759","Recovery Inspired Support Engagement (RISE) Pilot","(RISE)","Inclusion Criteria:\n\n* Inclusion Criteria for Support Persons:\n\n  * Ages 18+.\n  * Having a loved one who participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by loved one, support person, clinician, or chart review.\n  * Interest in supporting the loved one's recovery from substance use.\n  * At least 4 days per month virtual or in-person contact per month with the loved one.\n  * Access to a computer with internet or mobile phone with video conferencing capabilities.\n  * Ability to provide written informed consent.\n  * Speak and read English.\n* Inclusion Criteria for Loved Ones:\n\n  * Ages 18+.\n  * Participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by self, support person, clinician, or chart review.\n  * At least 4 days per month virtual or in-person contact per month with the support person.\n  * Access to a computer with internet or mobile phone with video conferencing capabilities.\n  * Ability to provide written informed consent.\n  * Speak and read English.\n\nExclusion Criteria:\n\n* Exclusion Criteria for Support Persons:\n\n  * DSM-5 moderate or severe substance use disorder in the past year.\n  * History of domestic violence with the loved one that would interfere with the ability to safely follow through with the intervention plan.\n  * Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.\n  * Prior participation of a support person of the loved one in an ITC-related research study.\n  * Significant prior experience with ITC or CRAFT (e.g., having completed an ITC-related training workshop or course prior to study enrollment)\n* Exclusion Criteria for Loved Ones: N\u002FA",{"count":285,"type":22},18,[25],"The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are:\n\nHow many people complete the program? How satisfied are people with the program?\n\nParticipants will:\n\nComplete weekly telehealth sessions for 12 weeks Complete surveys\u002Finterviews at the beginning, in the middle (\\~week 6), at the end of the program (\\~week 12), and 12-weeks after the end of the program Complete a focus group or interview",[289,290,291,292,293,294,295],"Support Persons","Family Members","Chosen Family","Romantic Partners","Friends","Caregivers","Substance Use Disorders",[289,293,295,297,298,299,300,301,302,292,291,290,294],"Alcohol","Substance Use (Drugs, Alcohol)","Social Support","Recovery","Invitation to Change","ITC","2026-04-23",{"date":305,"type":33},"2026-04-28",{"date":232,"type":22},{"date":308,"type":22},"2028-02-28",{"name":39,"class":40},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":319,"phases":4,"briefSummary":320,"conditions":321,"keywords":323,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":74},"100631621","identifying-substance-use-consequences-100631621","NCT07503067","Identifying Substance Use Consequences","Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials","Inclusion Criteria:\n\n* (1) ability to read and provide informed consent in English, and at least one of the following 2a) currently providing direct care to patients with substance use disorders, 2b) current or past treatment for an substance use disorder, or 2c) self-report of a close friend or family member who currently or previously received treatment for a substance use disorder.\n\nExclusion Criteria:\n\n* 1\\) major psychiatric or medical condition that would interfere with participation (e.g., acute psychosis, severe withdrawal); 2) current intoxication (positive breath alcohol test or behavioral evidence of other substance intoxication).",{"count":318,"type":22},50,"OBSERVATIONAL","The goal of this study is to develop a new tool for measuring substance use disorder treatment outcome. We will start by interviewing people and gathering advisory groups to develop the items for this new tool.",[322],"Substance Use Disorder (SUD)",[324,325,326],"substance use disorder","measurement","patient reported outcomes","2026-03-25",{"date":329,"type":33},"2026-03-31",{"date":331,"type":33},"2026-02-10",{"date":333,"type":22},"2027-07-31",{"name":39,"class":40},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":151,"minAge":341,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":74},"100552770","phase-2-evaluating-the-impact-of-a-novel-cannabinoid-product-for-endometriosis-100552770","NCT06477406","Evaluating the Impact of a Novel Cannabinoid Product for Endometriosis","Inclusion Criteria:\n\n1. Subject has provided informed consent\n2. Sex assigned female at birth\n3. Subject is 21 or older\n4. Subject is fluent in English\n5. Subject endorses at least moderate levels of pain at the baseline visit\n6. Subject endorses having endometriosis\n\nExclusion Criteria:\n\n1. Non-fluent English speakers\n2. Endorsement of current substance use disorder, psychotic disorder, or an eating disorder\n3. Currently uses cannabis or cannabinoid products regularly\n4. Patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding\n5. Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper\u002Fhypotension, cardiac disorders), or neurological disorder (including seizure disorder)\n6. Neuropathic pain or cancer-related pain\n7. Disclosure of a genetic polymorphism affecting CYP2C9 function","21 Years",{"count":343,"type":22},30,[85],"Despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. This study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-CBD product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. This project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.",[347],"Endometriosis","2026-03-24",{"date":350,"type":33},"2026-03-30",{"date":352,"type":33},"2024-02-27",{"date":354,"type":22},"2026-06",{"name":39,"class":40},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":74},"100474404","phase-2-assessing-the-impact-of-cannabidiol-for-anxiety-and-depression-in-bipolar-disorder-100474404","NCT05457465","Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder","Inclusion Criteria:\n\n* Provides informed consent\n* Between the ages of 18-65\n* Fluent in English\n* Meets DSM-5 criteria for bipolar disorder (type I or II)\n* Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)\n* On a stable pharmacotherapeutic regimen\n\nExclusion Criteria:\n\n* Not fluent in English\n* Estimated IQ \\\u003C75\n* Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)\n* Endorsement of suicidality\n* Experiencing acute manic episode\n* Experiencing acute depressive episode\n* History of head injury\u002Floss of consciousness \\>5 minutes\n* Current regular use of cannabinoid products\n* Pregnant or breastfeeding\n* Presence of serious medical illness or neurological disorder\n* Allergy to palm oil\n* Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis\n* Currently enrolled in another clinical trial that involves a treatment\n* Elevated LFTs at screening visit",{"count":7,"type":22},[85],"Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.",[366],"Bipolar Disorder",[368],"Cannabidiol",{"date":350,"type":33},{"date":371,"type":33},"2023-06-01",{"date":373,"type":22},"2026-12",{"name":39,"class":40},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":41},"100524364","cerebellar-modulation-of-cognition-in-psychosis-100524364","NCT06107764","Cerebellar Modulation of Cognition in Psychosis","Inclusion Criteria:\n\n* Age between 18-55 years\n* Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.\n\nExclusion Criteria:\n\n* Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month\n* Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:\n\n  * Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;\n  * History of fainting spells of unknown or undetermined etiology that might constitute seizures\n  * History of multiple seizures or diagnosis of epilepsy\n  * Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n  * Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n  * Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or transcutaneous electric nerve stimulation unit\n  * Ventriculo-peritoneal shunt\n  * Signs of increased intracranial pressure\n  * Intracranial lesion\n  * History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n  * Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.","55 Years",{"count":383,"type":22},95,[25],"The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).\n\nParticipants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.",[387,388,389,55],"Schizophrenia","Schizoaffective Disorder","Bipolar Disorder I","2026-03-16",{"date":392,"type":33},"2026-03-17",{"date":394,"type":33},"2024-07-31",{"date":396,"type":22},"2029-12",{"name":39,"class":40},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"100521612","enhanced-coordinated-specialty-care-for-early-psychosis-100521612","NCT06071858","Enhanced Coordinated Specialty Care for Early Psychosis","Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis","Inclusion Criteria:\n\n* People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:\n* McLean Hospital OnTrack (OnTrack Clinic)\n* Massachusetts General Hospital (FEPP Clinic)\n* Boston Medical Center (WRAP Clinic)\n* Cambridge Health Alliance (RISE Clinic)\n* UMass Memorial Health Care (STEP Clinic)\n* ServiceNet (PREP West)\n\nExclusion Criteria:\n\n* None",{"count":406,"type":22},350,[25],"The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:\n\n• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?\n\nParticipants will either:\n\n* Receive care as usual (CSC) or\n* Receive care as usual (CSC) plus five additional care elements (CSC 2.0):\n\n  1. Individual peer support\n  2. Digital outreach\n  3. Care coordination\n  4. Multi-family group therapy\n  5. Cognitive remediation\n\nResearchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.",[55,387,388,410,366],"Psychosis Nos\u002FOther",[412,413],"first episode psychosis","early psychosis","2026-02-25",{"date":416,"type":33},"2026-02-27",{"date":418,"type":33},"2024-02-01",{"date":420,"type":22},"2028-10",{"name":39,"class":40},5,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":381,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":445,"leadSponsor":447,"locationsCount":4},"100623505","mechanisms-of-written-exposure-therapy-in-residential-sud-treatment-100623505","NCT07397507","Mechanisms of Written Exposure Therapy in Residential SUD Treatment","Inclusion Criteria:\n\n1. ability to understand and sign informed consent\n2. ability to write in English;\n3. age between 18-55 (average age of menopause in the US)\n4. \\[women only\\] naturally cycling (i.e., regular cycles, not on gonadal-related hormones)\n5. current diagnosis of a moderate or severe DSM-5 SUD\n6. current diagnosis of DSM-5 PTSD\n7. sufficient memory of the trauma to write about the event\n8. at least 5 business days left in their residential treatment episode (to allow for 5 treatment sessions).\n\nExclusion Criteria:\n\n1. presence of a psychiatric or medical condition that would interfere with participation (e.g., severe, uncontrolled psychosis)\n2. prescription of a PRN benzodiazepine\n3. current PTSD treatment",{"count":430,"type":22},108,[25],"The goal of this clinical trial is to learn how Written Exposure Therapy (WET), a brief treatment for PTSD, works among individuals with substance use disorders (SUD) engaged in residential SUD treatment and how biology may influence treatment. The main questions it aims to answer are:\n\n* Does WET improve PTSD and substance use outcomes among individuals with SUD+PTSD?\n* Does WET improve physiological responses and craving to trauma cues?\n* Do sex hormones influence changes physiological responses and craving during treatment among women?\n\nParticipants will:\n\n* Complete WET or a neutral writing in addition to their residential SUD treatment\n* Complete two laboratory sessions before and after treatment\n* Complete follow-up surveys and interviews at 1- and 3-months post-treatment",[434,322],"PTSD - Post Traumatic Stress Disorder",[436,437,438,439,440],"PTSD treatment","Written Exposure Therapy","Substance Use Disorder","treatment mechanisms","fear extinction","2026-02-04",{"date":443,"type":33},"2026-02-09",{"date":354,"type":22},{"date":446,"type":22},"2030-03",{"name":39,"class":40},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":381,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":467,"locationsCount":74},"100465659","using-transcranial-magnetic-stimulation-tms-to-understand-hallucinations-in-schizophrenia-100465659","NCT05343598","Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia","Empirical Validation of a Cerebellar-cortical Hallucination Circuit","Inclusion Criteria:\n\n* Diagnosis of schizophrenia or schizoaffective disorder\n\nExclusion Criteria:\n\n* substance use disorder in past 3 months\n* ambidexterity\n* contraindications for TMS or MRI including :\n* history of neurological disorder\n* history of head trauma resulting in loss of consciousness\n* history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy\n* metal in brain or skull\n* implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt\n* claustrophobic in MRI",{"count":456,"type":22},68,[25],"This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.\n\nTMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.",[387,460],"Schizo Affective Disorder","2026-01-21",{"date":463,"type":33},"2026-01-22",{"date":465,"type":33},"2021-10-13",{"date":170,"type":22},{"name":39,"class":40},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":107,"sex":151,"minAge":475,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":319,"phases":4,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":74},"100417287","early-life-stress-and-depression-molecular-and-functional-imaging-100417287","NCT04713722","Early Life Stress and Depression: Molecular and Functional Imaging","ELS","Inclusion Criteria:\n\n* Females of all races and ethnic origins\n* Ages from 20 to 32\n* Right-handed\n* Capable of providing written informed consent\n* Currently unmedicated. Note that this criterion applies at enrollment only, and subjects will be informed that they can continue to be in the study if they begin a new medication after enrollment.\n* Normal or corrected-to-normal vision and hearing\n* Fluency in written and spoken English\n* Absence of first-degree relatives with a history of a psychotic disorder or psychotic symptoms; (adopted individuals are eligible to participate but we will probe about family history in case such information is available to the adopted subject)\n\nExclusion Criteria:\n\n* Participants with suicidal ideation where continued study participation is deemed unsafe by the study clinician (these participants will be immediately referred to appropriate clinical treatment)\n* Pregnant women, or women of childbearing potential who have a positive result on a urine pregnancy test\n* Failure to meet MRI safety requirements including but not limited to any metal implants or prostheses that cannot be removed, or exposure to shrapnel\n* Claustrophobia or severe anxiety that might impact participation in neuroimaging\n* Injury or movement disorder that may make it difficult to lie still in the scanner\n* Any current recreational\u002Fillicit drug use as assessed by a urine drug test (covering cocaine, cannabinoids, opiates, amphetamines, methamphetamines, phencyclidine, MDMA, benzodiazepines, methadone, oxycodone, tricyclic antidepressants, and barbiturates)\n* Use of drug or herbal supplement for depression (e.g., St. John's Wort or SAMe) of those that could affect stress response\n* Use of any medication in the 24 hours prior to the Scanning procedure (including antibiotics, asthma inhalants, pain relievers, antihistamines, or over-the-counter medications).\n* Recent use (within 3 weeks) or any medication that affects blood flow or blood pressure, or which is vasodilating\u002Fvasoconstricting\n* Use of Melatonin within 5 days of the Scanning procedure\n* Metformin use in the past 6 months (for either clinical care or as part of research)\n* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine (hypothyroidism), neurologic, autoimmune disease (such as Lyme, Crohn's), or hematologic disease\n* Current infectious illness (either transient or chronic); Current episode of allergic reaction or asthma\n* Hemophilia; Diabetes with poor glucose control; History of chronic migraine (\\> 15 days\u002Fmo.); History or current diagnosis of dementia\n* History of seizure disorder\n* Any history of significant head injury or concussion\n* Past\u002Fcurrent DSM-5 diagnosis of: OCD, ADHD, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders NOS, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, autism or any other pervasive developmental disorder, organic mental disorder, anorexia, binge eating disorder or bulimia (however a history of bulimia or binge eating disorder is allowable if it has been in remission for at least two years)\n* History of moderate or severe substance or alcohol use disorder; or, mild substance or alcohol use disorder within the last 12 months (with the exception of cocaine or stimulant abuse, which will lead to automatic exclusion).\n* History of ECT\n* Patient is clinically unstable, in the judgment of the clinician","20 Years","32 Years",{"count":478,"type":22},160,"Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.",[57,481],"Trauma, Psychological","2025-12-04",{"date":484,"type":33},"2025-12-12",{"date":486,"type":33},"2021-02-01",{"date":488,"type":22},"2026-06-30",{"name":39,"class":40},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":74},"100533133","ketogenic-and-nutritional-interventions-for-first-episode-bipolar-disorder-100533133","NCT06221852","Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder","A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.","Inclusion Criteria:\n\n* Between the ages of 18 and 45.\n* Ability to adhere to study diets.\n* Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.\n* Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening\n* Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent\n* Contraindication to magnetic resonance (MR) scan (including claustrophobia)\n* Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)\n* Current DSM-5 substance use disorder\n* Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception\n* Have a body weight of over 350 lbs or a body mass index (BMI) \\\u003C20\n* Score above 15 on the Young Mania Rating Scale (YMRS)\n* History of significant head injury\n* Current cancer diagnosis\n* Current diagnosis of type 1 or type 2 Diabetes Mellitus\n* History of gastric bypass surgery or any weight loss surgery\n* Concomitant treatment with Propofol\n* Familial hypercholesterolemia",{"count":318,"type":22},[25],"This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.",[88,55,388],[502,503,504,94,505,388,366,506,507,508],"First episode psychosis","Ketogenic Diet","Keto","Insulin resistance","Magnetic resonance spectroscopy (MRS)","Redox","Creatine kinase","2025-11-04",{"date":511,"type":33},"2025-11-05",{"date":513,"type":33},"2024-03-12",{"date":515,"type":22},"2027-12-30",{"name":39,"class":40},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":319,"phases":4,"briefSummary":527,"conditions":528,"keywords":539,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":74},"100458152","passive-sensor-identification-of-digital-biomarkers-to-assess-effects-of-orally-administered-nicotinamide-riboside-100458152","NCT05245903","Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside","Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside on Bioenergetic Metabolism, Oxidative Stress, and Cognition in Mild Cognitive Impairment and Mild Alzheimer's Dementia","Emerald-NRAD","Inclusion Criteria:\n\n* Ability of the participant and\u002For his\u002Fher legally authorized representative to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information.\n* Ability to speak and read fluently in English\n* 18-89 years old (inclusive)\n* Normal or corrected to normal hearing and vision\n* Meet clinical diagnostic criteria for MCI or Mild AD, according to the criteria outlined above\n* Study partner available for duration of trial participation\n* At least one copy of the APOE ε4 allele\n* An aggregate risk score \\> 4 according to the risk analysis method developed by Sabbagh et al. (2017)\n* For individuals who are taking niacin (or a vitamin supplement with niacin) of \\>200mg, the completion of a two-week wash-out period\n\nExclusion Criteria:\n\n* Current serious or unstable medical or neurological condition that could affect cognitive functioning, as determined by study clinician\n* Clinically unstable mood or anxiety disorder within 6 months prior to screening, as determined by study clinician\n* Lifetime history of psychotic disorder (i.e. Schizophrenia, Schizoaffective Disorder), as determined by study clinician\n* Diagnosis of a mitochondrial disorder\n* Any MRI safety contraindications\n* History of drug hypersensitivity or intolerance to NR\n* Transient ischemic attack or stroke within 1 year prior to screening\n* History of alcohol or substance abuse within prior year, as determined by study clinician and urine toxicology screen\n* History of head injury rated as moderate or worse, per DSM-5 criteria\n* History of seizure within prior 10 years\n* Current use of medication with known adverse effects on cognition (benzodiazepines, barbiturates, opiate analgesics, first generation antipsychotic medication, anticholinergics, sedating antihistamines, tricyclic anti-depressants)\n* Change in dose of any psychiatric medications within 4 weeks of screening visit\n* Prior use of L-DOPA, any anti-Parkinsonian medication, or prior treatment with anti-amyloid immunotherapy\n* Current use of putative mitochondrial enhancers or antioxidants (e.g. carnitine, creatine, Co-Q10, N-acetyl cysteine, pramipexole)\n* Initiation of treatment or change in dosing of acetylcholinesterase inhibitors (AChEIs) and memantine within 4 weeks of screening\n* Prior use of prescription narcotics 4 weeks before screening\n* Female subjects who are pregnant or breastfeeding\n* The current use of niacin (or a vitamin supplement with niacin) \\>200mg within the last two weeks prior to study visit","89 Years",{"count":83,"type":22},"This project's main goal is to use state-of-the-art passive sensing techniques to identify digital biomarkers that relate to bioenergetic changes in the brain due to nicotinamide riboside supplementation in those with mild cognitive impairment and mild Alzheimer's dementia.",[529,530,531,532,533,534,535,536,537,538],"Alzheimer Disease","Dementia Alzheimers","Dementia","Cognitive Impairment","Mild Cognitive Impairment","Neurodegenerative Diseases","Neurocognitive Disorders","Neurocognitive Dysfunction","Cognitive Dysfunction","Mental Disorder",[540,541,542,533,543],"Passive sensing","Digital phenotyping","Alzheimer's Dementia","Digital biomarker",{"date":545,"type":33},"2025-11-06",{"date":547,"type":33},"2022-05-31",{"date":549,"type":22},"2026-05-31",{"name":39,"class":40},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":107,"sex":151,"minAge":108,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":74},"100578825","stress-dynamics-and-familial-risk-for-depression-in-female-adolescents-100578825","NCT06816329","Stress Dynamics and Familial Risk for Depression in Female Adolescents","Tracking the Dynamic Trajectory of Behavioral, Physiological, and Neurobiological Stress Responses in Female Adolescents at High and Low Familial Risk for Depression","Inclusion Criteria: General Inclusion Criteria for all Adolescent Cohorts:\n\n* Female sex assigned at birth\n* Ages 13-15\n* English as first language or English Fluency\n* Right-handed\n* Have a personal cell phone to complete the ecological momentary assessments\n* Ability to give signed, informed consent\u002Fassent either written or electronic (via RedCap eConsent)\n* Normal or corrected to normal vision and hearing\n\nAdditional Inclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group:\n\n• A biological parent meeting DSM-5 criteria for at least one past\u002Fcurrent major depressive episode\n\nExclusion Criteria: General Exclusion Criteria for all Adolescent Cohorts:\n\n• Presence of any contraindication for MRI:\n\n* Cardiac pacemakers\n* Metal clips on blood vessels (also called stents)\n* Artificial heart valve, artificial arms, hands, legs, etc.\n* Brain stimulator devices\n* Implanted drug pumps\n* Ear or eye implants\n* Known metal fragments in eyes\n* Exposure to metal filings or shrapnel (sheet metal workers, welders, and others)\n* Other metallic surgical hardware in vital area\n* Certain tattoos with metallic ink\n* Certain intrauterine devices (IUDs) containing metal\n* Any other metallic objects that are deemed a contraindication to MRI that cannot be removed\n* Certain transdermal (skin) patches such as:\n\nNicoDerm (nicotine for tobacco dependence) Transderm Scop (scopolamine for motion sickness) Ortho Evra (birth control)\n\n* Presence of medical or neurological illness that could impact fMRI measures of cerebral blood flow (e.g., head injury resulting in loss of consciousness greater than 5 minutes, seizure, tic disorder, serious\u002Funstable cardiac, hepatic, renal, respiratory, endocrine, neurologic or hematologic illnesses)\n* Clinical\u002FLaboratory Evidence of Hypothyroidism or Hyperthyroidism\n* Use of hormonal replacement therapy, anabolic steroids\n* Lifetime history of electroconvulsive therapy\n* Current tobacco product use\n* Lifetime use of any psychotropic medication\n* Clinically significant levels of depressive symptoms according to the Children's Depression Rating Scale-Revised (T Score \\> 54, Poznanski et al., 1996)\n* Diagnosis of a neurodevelopmental disorder (e.g., Autism Spectrum Disorder, Learning Disorder w\u002F impairment in reading) that would interfere with study tasks (e.g., understanding and completing lengthy battery of questionnaires, ability to complete fMRI scan session and tasks without moving)\n\nAdditional Exclusion Criteria for Female Adolescents with a Parental History of MDD, high-risk group:\n\n• Lifetime or current Diagnostic and Statistical Manual (DSM)-5 diagnoses of MDD, persistent depressive disorder, schizophrenia spectrum or other psychotic disorder, bipolar disorder, substance\u002Falcohol use disorder, eating disorders, and posttraumatic stress disorder\n\nAdditional Exclusion Criteria for Female Adolescents without a Parental History of MDD, low-risk group:\n\n* Any past or current Diagnostic and Statistical Manual (DSM)-5 psychiatric or substance\u002Falcohol use disorder\n* First-degree relative history of any psychiatric disorder","15 Years",{"count":560,"type":22},148,[25],"Stress and a parental history of major depressive disorder (MDD) are among the strongest risk factors for future development of MDD. Studies have shown that having a parental history of MDD may be associated with behavioral, psychophysiological, and hormonal responses to stress that are associated with poorer stress coping. . Adolescence is a vulnerable developmental window linked to increased MDD risk, especially for females, as rates of MDD surge relative to males. Despite the central role of stress in MDD onset, little is known about the brain mechanisms underlying stress responses in susceptible female adolescents at high familial risk for MDD. Also, it is unclear how stress-related brain network alterations may relate to \"real-world\" maladaptive stress responses and whether these stress-related brain network changes are predictive of future depression onset. We will fulfill these research gaps by combining neuroimaging with intensive longitudinal tracking of depressive symptomology as well as behavioral and physiological responses to \"real world\" stress using smartphone and smartwatch technology. Elucidating these neural mechanisms may aid in the discovery of MDD biomarkers that could identify youth at greatest risk for future MDD development and lead to earlier intervention efforts.",[158],[160,163,565,162,566],"adolescents","familial risk","2025-10-22",{"date":569,"type":33},"2025-10-23",{"date":571,"type":33},"2025-10-15",{"date":573,"type":22},"2030-03-31",{"name":39,"class":40},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":107,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":581,"targetDuration":4,"studyType":319,"phases":4,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":74},"100487736","beyond-monoamines-the-role-of-the-nociceptinorphanin-fq-receptor-in-major-depression-100487736","NCT05630963","Beyond Monoamines: The Role of the Nociceptin\u002FOrphanin FQ Receptor in Major Depression","Inclusion Criteria for all participants:\n\n* All genders, races, and ethnic origins, aged between 18 and 45\n* Capable of providing written informed consent, and fluent in English\n* Right-handed\n* Absence of any psychotropic medications for at least 2 weeks\n* Has a smartphone (iPhone or Android) (needed for Ecological Momentary Assessment)\n\nInclusion Criteria for \"Remitted MDD\" group:\n\n* Meets inclusion criteria for all subjects, plus:\n* History of MDD as defined by DSM-5\n* Absence of anxiety disorder for the past two months\n\nInclusion Criteria for \"Current MDD\" group:\n\n* Meets inclusion criteria for all subjects, plus:\n* Presence of MDD as defined by DSM-5\n* Absence of anxiety disorder for the past two months\n\nExclusion Criteria for all participants:\n\n* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment\n* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s\u002Fp tubal ligation, or partner with vasectomy)\n* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease\n* History of seizure disorder\n* History of psychiatric illnesses, other than depression or anxiety disorders among the Current MDD and Remitted MDD groups\n* History of substance use disorder or alcohol use disorder (as these terms are defined by DSM-5); except depressed subjects may have a history of 'Mild' substance\u002Falcohol use disorder only if it ended as least 12 months ago\n* History of cocaine or stimulant use or dopaminergic drugs\n* History or current diagnosis of dementia, or a score of \\\u003C 26 on the Mini Mental State Examination at the screening visit;\n* Patients with mood congruent or mood incongruent psychotic features\n* Current use of other psychotropic drugs\n* Clinical or laboratory evidence of hypothyroidism\n* Patients with a lifetime history of electroconvulsive therapy (ECT)\n* Failure to meet standard MRI safety requirements\n* Abnormal ECG and lab results\n* History of seizure disorder\n* Contraindications for arterial line (e.g., abnormal result on Allen test, Raynaud's syndrome, history of anemia or bleeding disorder, history of fainting from blood draws).",{"count":582,"type":22},228,"This study looks at the role of the Nociceptin\u002FOrphanin FQ receptor system in the brain of individuals with current or past major depressive disorder (MDD). It also examines how individuals with a history of depression make certain decisions and which brain regions are involved in such decisions. Information collected through MRI, PET, biospecimens (i.e., blood, saliva) and behavioral tasks will be used to predict depressive symptoms in the future.",[158],"2025-10-17",{"date":587,"type":33},"2025-10-21",{"date":589,"type":33},"2021-12-29",{"date":591,"type":22},"2027-02-28",{"name":39,"class":40},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":600,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":74},"100490389","role-of-parent-interpretation-bias-in-the-transmission-of-anxiety-to-children-100490389","NCT05665491","Role of Parent Interpretation Bias in the Transmission of Anxiety to Children","Parent Interpretation Bias as a Key Mechanism of Intergenerational Transmission of Anxiety","Inclusion criteria for parent participants are:\n\n1. Must have an ability to speak and understand English sufficiently to complete assessments\n2. At least minimal anxiety severity (GAD-7 score \\> 5)\n3. At least a minimal level of interpretation bias (WSAP overall accuracy less than 70%)\n4. No current psychiatric symptoms that would interfere with the individual's ability to provide consent or complete the research procedures\n5. If receiving treatment, stable on medications or psychotherapy for 8 weeks\n6. No severe suicidal ideation (PHQ-9 item 9 \\> 1)\n7. Own iOS or Android smartphone\n8. Shared or full custody of child (for EMA assessment of parenting behaviors)\n\nInclusion criteria for child participants are:\n\n1. Age 7 to 12\n2. Must have an ability to speak and understand English sufficiently to complete assessments\n3. No diagnosis of intellectual disability or autism spectrum disorder (per parent or clinician report)\n4. No current psychiatric symptoms that would prevent informed consent or understanding of research procedures\n5. Wechsler Abbreviated Scale of Intelligence (WASI) full-scale IQ equal to or greater than 80 to ensure understanding of study procedures\n6. If receiving treatment, stable on medications or psychotherapy for 8 weeks\n7. No severe suicidal ideation (PHQ-9 item 9 \\> 1)","7 Years",{"count":602,"type":22},300,[25],"Approximately 30% of children will experience an anxiety disorder, making anxiety the most common mental health problem among children in the United States. However, few children receive treatment and even our most effective anxiety treatments leave up to half of children in need of additional intervention. Despite the well-established role of parent anxiety in transmitting and maintaining child anxiety, the lack of data on specific parent mechanisms underlying the intergenerational transmission of anxiety is a critical barrier to informing novel targets of personalized treatments. Consistent with NIMH's Strategic Plan, Objective 2.2 to understand risk factors and behavioral indicators of mental illness across the lifespan and to identify novel intervention targets based on knowledge of psychological mechanisms, the current study focuses on interpretation bias, the tendency to perceive threat in ambiguous situations. The overall objective of this project is to empirically test a theoretical model of the intergenerational transmission of anxiety focused on parent interpretation bias as a root cause. Our specific aims are to test theorized effects of parent interpretation bias on (1) parent behavior and (2) child interpretation bias and (3) evaluate potential moderators to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. Our central hypothesis is that parent interpretation bias influences child interpretation bias through its effects on maladaptive, anxiety-promoting parenting behaviors, such as accommodation and modeling of avoidant coping. To test this hypothesis, we will randomize 300 parents of children ages 7-12 to complete four weeks of a smartphone delivered interpretation bias manipulation vs. a self-assessment smartphone app condition. The interpretation bias intervention teaches parents to interpret ambiguous situations in a non-threatening manner via quick, repeated practice and corrective feedback. Before and after completing their randomly assigned condition, parent-child dyads will complete self-report and behavioral tasks designed to elicit anxiety-promoting behaviors from parents depending upon their interpretation of the ambiguous situation (speech and puzzle tasks). Parents will also complete Ecological Momentary Assessment (EMA) of parenting behaviors to capture the time course of effects. Finally, we will examine downstream effects of the interpretation manipulation on child interpretation bias at pre- and post- visits. We will test moderators (e.g., parent anxiety and gender) to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. The long-term goal of this work is to inform personalized, mechanism-focused interventions to improve mental health outcomes for anxious children and their parents. Future studies will translate knowledge gained from this project into a scalable treatment that can be implemented entirely remotely via smartphone thereby increasing access to care",[56],"2025-09-24",{"date":608,"type":33},"2025-09-29",{"date":610,"type":33},"2023-07-28",{"date":612,"type":22},"2027-11-30",{"name":39,"class":40},""]