[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depressive-disorder-major\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depressive-disorder-major":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,43,89,119,147,170,192,211,233,258,279,303,322,340,364,396,424,450,472,498,523,549,571,599,620],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605359","brain-functional-connectivity-mechanism-of-cognitive-flexibility-impairment-and-rtms-intervention-in-major-depressive-disorder-100605359",false,"NCT07161492","Brain Functional Connectivity Mechanism of Cognitive Flexibility Impairment and rTMS Intervention in Major Depressive Disorder","Individualized Dual-Target Repetitive Transcranial Magnetic Stimulation (rTMS) Targeting Left Inferior Parietal Lobule and Right Dorsolateral Prefrontal Cortex Functional Connectivity for Cognitive Flexibility Impairment in Major Depressive Disorder: A Randomized, Double-Blind-Controlled Trial","Inclusion Criteria:\n\nMeet DSM-5 criteria for major depressive episode confirmed by the Structured Clinical Interview for DSM-5 Disorders (SCID-5), with no prior manic or hypomanic episodes; diagnosed as major depressive disorder without psychotic features by two attending psychiatrists.\n\nFirst episode or recurrent, currently in a depressive episode (HAMD\\_17≥17).\n\nAge 18 to 45 years, all sexes and genders. Han Chinese, right-handed. Junior high school education or above, no color blindness, able to understand and provide informed consent, and complete assessments and tests.\n\nWilling to participate voluntarily and sign written informed consent.\n\nExclusion Criteria:\n\nMeet DSM-5 diagnostic criteria for any psychiatric disorder other than major depressive disorder.\n\nReceived non-pharmacological treatments within the past 6 months, such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or systematic psychotherapy (≥ 10 sessions).\n\nPrior treatment with CCRT. Received antipsychotics or other medications affecting cognitive function within the past month, or cholinergic agents (e.g., donepezil, galantamine) within 14 days, memantine within 20 days, or other racetam drugs (e.g., piracetam) within 2 days prior to randomization.\n\nOrganic brain disorders or severe physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes, liver\u002Fkidney\u002Flung impairment, infection, major trauma).\n\nHistory of traumatic brain injury with loss of consciousness or other conditions that may interfere with this study.\n\nHistory of alcohol or substance abuse or dependence. Severe suicidal ideation or suicide attempt . Currently receiving hormonal therapy. Pregnancy, lactation, possibility of pregnancy, or planned pregnancy. History of epilepsy or family history of epilepsy. Implanted metal materials in the body (e.g., pacemaker, dental implants, metal intrauterine device).\n\nAny other factors that, in the investigator's opinion, place the participant at potential risk or interfere with the study participation.","ALL","18 Years","45 Years",{"count":21,"type":22},105,"ESTIMATED","INTERVENTIONAL",[25],"NA","Major depressive disorder (MDD) often involves cognitive deficits, particularly in cognitive flexibility, which is inadequately addressed by standard antidepressants. This study tests an innovative brain stimulation regimen: individualized dual-target repetitive transcranial magnetic stimulation (rTMS) to improve cognitive flexibility in MDD patients.\n\nThis is a randomized, double-blind, sham-controlled trial that plans to enroll 105 MDD patients with cognitive flexibility impairment. Participants will be randomly assigned to one of three groups: (1) Active dual-target group - receiving active rTMS over both the left inferior parietal lobule (IPL) and the right dorsolateral prefrontal cortex (DLPFC); (2) Active single-target group - receiving active rTMS over the left IPL and sham stimulation over the right DLPFC; (3) Sham control group - receiving sham stimulation over both targets. All participants will continue their stable antidepressant medication (SSRI or SNRI). The rTMS intervention lasts 10 days, with 5 stimulation sessions per day.\n\nCognitive flexibility, depressive symptoms, and brain functional connectivity will be assessed at baseline, immediately after the 10-day treatment, and at 2-week and 4-week follow-ups using neurocognitive tests, clinical rating scales (e.g., HAMD), and functional MRI. The results will help confirm the role of the IPL-DLPFC connectivity in cognitive flexibility and may establish a new treatment target for cognitive dysfunction in MDD.",[28,29],"Depressive Disorder, Major","Cognitive Impairment","NOT_YET_RECRUITING","2026-06-22",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":22},"2026-07",{"date":38,"type":22},"2028-10",{"name":40,"class":41},"Second Xiangya Hospital of Central South University","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":69,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":42},"100555424","phase-2-investigation-of-the-antidepressant-effects-of-2r6r-hnk-an-enhancer-of-synaptic-glutamate-release-in-treatment-resistant-depression-100555424","NCT06511908","Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","An Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \\>= 80% on the consent quiz.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. 18 to 70 years of age.\n4. All participants must have undergone a screening assessment under protocol 01-M-0254.\n5. Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants must be experiencing a current major depressive episode lasting at least two weeks.\n6. Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\\u003C12 within one week of study entry and upon entry into Phase II.\n7. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.\n8. Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode, operationally defined using the modified Antidepressant Treatment History Form (ATHF); non-response to an adequate trial of ECT or TMS would count as an adequate antidepressant trial.\n9. For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II.\n10. For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.\n11. Agreement to adhere to Lifestyle Considerations throughout study duration.\n12. Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.\n2. Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.\n3. Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.\n4. Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.\n5. Ongoing treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers\n6. Lifetime history of deep brain stimulation.\n7. Previous antidepressant non-response to ketamine or esketamine (full course).\n8. No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.\n9. Pregnancy or lactation.\n10. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n11. Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to starting Phase II. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician. Due to the interactions between cannabis and SSRIs, frequent cannabis use during previous antidepressant treatment will result in that treatment being considered a failed trial for eligibility purposes.\n12. Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.\n13. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).\n14. No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely participate in the study: Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver, any liver disease with Child-Pugh score \\>=5), cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug), renal\u002Furologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis, moderate to severe renal impairment of any etiology), endocrinologic (including uncontrolled diabetes due to association with progressive abnormality of the microvasculature and nervous system), or neurologic disease (e.g. elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n15. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n16. Participants with one or more seizures without a clear and resolved etiology.\n17. Clinically significant abnormal laboratory tests specifically defined by:\n\n    * Alkaline phosphatase (Alk Phos) \\> 150 U\u002FL\n    * Alanine aminotransferase (ALT) \\> 55 U\u002FL\n    * Aspartate aminotransferase (AST) \\> 34 U\u002FL\n    * Total bilirubin (TB) \\> 1.2 mg\u002FdL\n    * Direct bilirubin (DB) \\> 0.5 mg\u002FdL\n    * 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n    * Folate \\\u003C 2ng\u002FmL\n    * Vitamin B12 \\\u003C 200 pg\u002FmL\n18. Moderate to severe renal impairment with body surface area corrected eGFR \\\u003C60mL\u002Fmin.\n19. Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.\n20. Positive HIV test.\n21. Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)\n22. Participants with COVID-19 or suspected COVID-19\n23. Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.","70 Years",{"count":52,"type":22},50,[54],"PHASE2","Background:\n\nMajor depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.\n\nObjective:\n\nTo test a study drug (HNK) in people with MDD.\n\nEligibility:\n\nPeople aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.\n\nHNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:\n\nThey will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.\n\nThey will receive no drugs for 2 to 3 weeks.\n\nThey will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.\n\nOne set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.\n\n...",[57,58,59,60,61,62,63,28,64,65,66,67,68],"Suicide","Depressive Disorder, Treatment-Resistant","Ketamine","Molecular Mechanisms of Pharmacological Action","Neurotransmitter Agents","Excitatory Amino Acid Agents","Physiological Effects of Drugs","Depressive Disorder","Depression","Mental Disorders","Mood Disorders","Behavioral Symptoms",[70,59,71,72,73,74,75,76,77],"Major Depressive Disorder","Biomarkers","Neuropharmacology","Magnetic Resonance Imaging","Magnetoencephalography","Neurobiology","Glutamate","Hydroxynorketamine","RECRUITING","2026-06-13",{"date":81,"type":34},"2026-06-16",{"date":83,"type":34},"2024-11-06",{"date":85,"type":22},"2027-07-01",{"name":87,"class":88},"National Institute of Mental Health (NIMH)","NIH",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100641745","student-precarity-and-psychiatry-100641745","NCT07618208","Student Precarity and Psychiatry","Impact of Precarity on the Emergence of Psychiatric Disorders and the Use of Care Among Students","PEPSY","Inclusion Criteria:\n\n* Student enrolled at Paris Sciences et Lettres University (PSL, 17,000 students) or the Faculty of Health Sciences at Paris Cité University (UPC, 28,000 students),\n* Aged 18 or over,\n* Fluent in French,\n* Affiliated to a health insurance.\n\nExclusion Criteria:\n\n* Applicants under the age of 18,\n* Not enrolled at PSL universities or the UPCS Faculty of Health,\n* Insufficient level of French.",true,{"count":99,"type":22},45000,"OBSERVATIONAL","Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship.\n\nStudents often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment.\n\nThe aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services.\n\nOur study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.",[28,103,104,105],"Generalized Anxiety Disorder","Suicidal Ideation","Loneliness",[107,65,108,109],"Students","Use of care","Precarity","2026-06-11",{"date":112,"type":34},"2026-06-15",{"date":114,"type":22},"2026-09",{"date":116,"type":22},"2028-11",{"name":118,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100624678","phase-3-a-study-of-brenipatide-in-adult-participants-with-major-depressive-disorder-100624678","NCT07412756","A Study of Brenipatide in Adult Participants With Major Depressive Disorder","A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)","RENEW-MDD-1","Inclusion Criteria:\n\n* Meet the diagnostic criteria for major depressive disorder\n* Are on a stable standard of care medication for major depressive disorder\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires\n\nExclusion Criteria:\n\n* Have a lifetime history or current diagnosis of the following:\n\n  * schizophrenia or other psychotic disorder\n  * bipolar disorder\n  * borderline personality disorder, or\n  * any eating disorder.\n* Have type 1 diabetes mellitus, or a history of\n\n  * ketoacidosis, or\n  * hyperosmolar state or coma.\n* Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening\n* Are actively suicidal or deemed a significant risk for suicide\n* Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening","75 Years",{"count":129,"type":22},1000,[131],"PHASE3","This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.\n\nThe trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.",[28],[135,67,65,64],"Major Depressive Episode","2026-06-09",{"date":138,"type":34},"2026-06-10",{"date":140,"type":34},"2026-02-09",{"date":142,"type":22},"2028-02",{"name":144,"class":145},"Eli Lilly and Company","INDUSTRY",186,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100637014","phase-3-a-study-of-seltorexant-as-monotherapy-in-adults-and-elderly-participants-with-major-depressive-disorder-100637014","NCT07573176","A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder","A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant","Inclusion criteria:\n\n* Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment\n* Experienced at least one MDD episode prior to their current episode\n* Current episode of MDD must be a minimum of 2 weeks in duration\n* Must meet one of the following criteria regarding current medication status.\n\n  1. Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record\u002Fsource document).\n\n     OR\n  2. Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.\n* Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg\u002Fm\\^2)\n* Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)\n\nExclusion criteria:\n\n* Use of ketamine\u002Fesketamine in the current depressive episode (up to 2 doses are allowed prior to screening)\n* Has treatment-resistant depression (TRD)\n* Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years\n* Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia\n* Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders\n* Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder\n* Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months\n* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months\n* Has any significant sleep disorder, including but not limited to untreated\u002Funcontrolled conditions\n* Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients","74 Years",{"count":156,"type":22},600,[131],"The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\\[MDD\\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.",[28],"2026-06-04",{"date":162,"type":34},"2026-06-05",{"date":164,"type":34},"2026-04-30",{"date":166,"type":22},"2029-05-03",{"name":168,"class":145},"Janssen Research & Development, LLC",10,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100610428","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-esketamine-for-reduction-of-symptoms-of-major-depressive-disorder-100610428","NCT07227454","A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder","A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior","AVENUE","Inclusion Criteria:\n\n* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)\n* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of \"Markedly\" or greater (that is, greater than or equal to \\[\\>=\\] 4) at both screening and baseline (predose) visits\n* Must have a children's depression rating scale - revised (CDRS-R) total score \\>= 58 at baseline (predose)\n* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality\n* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening\n\nExclusion Criteria:\n\n* Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder\n* Participant currently meets DSM-5 criteria for borderline personality disorder\n* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis\n* Participant has a history of seizure disorder\n* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients","12 Years","17 Years",{"count":181,"type":22},258,[131],"The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.",[28],{"date":162,"type":34},{"date":187,"type":34},"2026-01-08",{"date":189,"type":22},"2031-09-15",{"name":168,"class":145},27,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":154,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100559067","phase-3-phase-3-study-of-adjunctive-treatment-with-seltorexant-in-adult-and-elderly-participants-with-major-depressive-disorder-and-insomnia-symptoms-100559067","NCT06559306","Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms","A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms","Inclusion Criteria:\n\nParticipants in part 1 and direct enrollers to part 2:\n\n* Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60\n* Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\\\u003C) 50% reduction but with some improvement (that is, improvement greater than \\[\\>\\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment\n* Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks\n* Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening.\n\nParticipants entering after completing part 1:\n\n* Must have completed Part 1 DB treatment phase\n* Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2\n* Was able to consistently follow the study procedures in Part 1 as judged by the investigator.\n* Must be medically stable based on clinical laboratory tests\n\nExclusion Criteria:\n\n* Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus\n* Has a history of narcolepsy and seizures\n* Has current signs\u002Fsymptoms of hypothyroidism or hyperthyroidism\n* Participants taking thyroid supplementation for antidepressant purposes\n* Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis",{"count":200,"type":22},752,[131],"The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).",[28],{"date":162,"type":34},{"date":206,"type":34},"2024-07-25",{"date":208,"type":22},"2026-12-30",{"name":168,"class":145},205,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":42},"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",{"count":219,"type":22},112,[54],"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).",[28,223],"Anxiety Disorder","2026-05-15",{"date":226,"type":34},"2026-05-18",{"date":228,"type":34},"2025-02-01",{"date":230,"type":22},"2027-03-31",{"name":232,"class":41},"Mclean Hospital",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":42},"100509560","phase-1-alpha-amino-3-hydroxy-5-methyl-4--isoxazole-propionic-acid-receptor-components-of-the-anti-depressant-ketamine-response-100509560","NCT05915013","Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response","Inclusion Criteria Substudy #2:\n\n* Right-handed as determined by the Edinburgh Handedness Inventory\n* Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale\n* Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials\n* Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be treated as ketamine responders and entered directly into the closed label trial.\n* Participants will meet DSM-5 Criteria for MDD as determined by the SCID-5\n* All participants given ketamine must be engaged in treatment outside of the research protocol. Those who are not currently in treatment may be referred for treatment.\n* Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. In addition, they should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.\n* Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial.\n* Willing to refrain from caffeine, drug and alcohol use for one week prior to each MRI session\n* Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy). Women who are surgically sterile or post-menopausal with cessation of menses for at least one year are not required to use birth control. If a woman should become pregnant during the study, she will be excluded from the trial.\n* Females will receive ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps during this entire follicular phase, she will be studied during another part of her cycle. She will be studied during the same part of her cycle for each scan, if possible.\n* Able to read and write English\n* Have at least a 12th grade education level or equivalent\n\nExclusion Criteria Substudy #2:\n\n* A score on the Columbia Suicide Severity Rating Scale in the \"intent\" or \"intent with plan\" categories or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.\n* Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion visits within 24 hours of a migraine. More than mild head injury is indicated by the presence of any of the following:\n\n  * More than half hour unconsciousness after trauma\n  * More than one hour post-traumatic amnesia\n  * Concussive symptoms such as headache, memory problems, nausea\u002Fvomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.\n  * Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.\n  * Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.\n* Current therapeutic treatment with ketamine\n* Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization\n* Daytime use of benzodiazepines\n* Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization\n* Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization\n* Psychosis other than psychotic experiences congruent with depressed mood during a period of depression\n* Insulin-dependent diabetes or non-insulin dependent diabetes that is poorly controlled\n* Other major medical disorder unless cleared by a study physician\n* History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable sobriety with no violent incidents or an individual who had received successful pharmacotherapy for impulse control difficulties may be included.\n* Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to screening date may be included in the study at investigator discretion. The diagnosis of mild alcohol use disorder shall be per DSM-5 and involve 2-3 symptoms. The PI's discretion will be based on the symptoms that are reported. The purpose of including individuals with mild alcohol use disorder is to extend recruitment to more individuals who can participate safely in the trial.\n* A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the scans.\n* A positive screening breathalyzer test or, at the study physicians' discretion, on any breathalyzer test given before the scans. This applies to all subjects, including those who make criteria for current mild alcohol use disorder.\n* A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.\n* Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the study physician considers that such findings will not introduce additional risk factors.\n* History of positive HIV or Hepatitis B\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinions of the Principal\u002FCo-Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Known sensitivity to ketamine or heparin\n* Resting blood pressure lower than 85\u002F55 or higher than 140\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin, unless cleared by study physician. If a subject meets these blood pressure entrance criteria, but is being treated for high blood pressure, the study team will check with the subject's primary care physician or treatment provider to confirm that the subject is stable and normotensive on their current treatment plan.\n* History of general intellectual disability\n* History of claustrophobia\n* Any clinically significant impairment of color vision or visual acuity after correction available in the scanner\n* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a Yale Magnetic Resonance Research Center standard pre-MRI screening questionnaire\n* Subjects will be advised not to drive or operate heavy machinery for at least 24 hours after completing the infusion.\n* Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.\n* Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.","60 Years",{"count":52,"type":22},[242],"PHASE1","The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.",[28,245],"Post Traumatic Stress Disorder",[59,247,245,248,73],"Major Depression","AMPA Receptor","2026-05-05",{"date":251,"type":34},"2026-05-06",{"date":253,"type":34},"2023-09-07",{"date":255,"type":22},"2032-12",{"name":257,"class":41},"Yale University",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":42},"100582257","phase-3-roflumilast-as-an-adjunct-to-antidepressants-in-major-depressive-disorder-patients-100582257","NCT06860958","Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients","Inclusion Criteria:\n\n1. Patients with age greater than 18 years old.\n2. Patients with Ham-D score at least 18 with item 1 depressed mood scored 2 or greater are eligible.\n\nExclusion Criteria:\n\n1. Patients with bipolar I or bipolar II disorder; eating disorders, personality disorders, and mental retardation, current diagnosis anxiety disorders (except for specific phobia), mental disorder due to general medical condition; met criteria for substance dependence or abuse in the previous three months; have a concurrent medical illness or history of seizures that would contraindicate use of the study medication and are receiving Electroconvulsive therapy (ECT).\n2. Pregnant women or women not using medically accepted means of birth control are excluded.\n3. Persons who score greater than 2 on the suicide item of the Ham-D, or who are judged to have significant suicidal ideation or potential in the view of an investigator, are excluded.\n4. Patients who are required to be free of all psychotropic except for escitalopram and anti-inflammatory medications for at least four weeks before study entry.","65 Years",{"count":266,"type":22},60,[131],"Major depressive disorder (MDD) is one of the most common psychiatric disorders with serious socioeconomic consequences on daily life and health care costs. Despite the advent of newer antidepressants that target monoamine pathways, nearly 50% of patients have no response to first-line antidepressant therapy. Thus, a combination of medications with different strategies at the beginning of treatment could provide further therapeutic benefits to MDD patients",[28],"2026-05-01",{"date":272,"type":34},"2026-05-04",{"date":274,"type":34},"2025-03-01",{"date":276,"type":22},"2027-08-20",{"name":278,"class":41},"Tanta University",{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":286,"maxAge":127,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100591622","self-neuro-modulation-therapy-for-major-depressive-disorder-mdd-with-anhedonia-100591622","NCT06982820","Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia","A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy","Inclusion Criteria:\n\n1. Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM5TR) - HDRS-17 score of ≥20, SHAPS-C score of ≥25.\n2. Fluency in written and spoken English.\n3. Able intellectually to understand the instructions\n4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent).\n5. Normal or corrected-to-normal vision and hearing.\n6. Ability to adhere to the study schedule.\n7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., metal in the body, claustrophobia).\n2. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using Columbia -Suicide Severity Rating Scale (C-SSRS) prior to screening and during the screening period.\n3. Diagnosis for current moderate or severe substance or alcohol use disorder (SUD\u002FAUD) within the past month (as defined in DSM-5-substance use disorder).\n4. Any unstable medical condition, as per the clinical judgement of the investigator.\n5. Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs\u002FSNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.\n6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.\n7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.","22 Years",{"count":288,"type":22},170,[25],"The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting.\n\nDuring this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).",[28],[293,294,65],"Major Depressive Disorder (MDD)","Anhedonia",{"date":270,"type":34},{"date":297,"type":34},"2025-06-25",{"date":299,"type":22},"2027-08-30",{"name":301,"class":145},"GrayMatters Health Ltd.",3,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":42},"100438071","phase-2-the-efficacy-and-safety-of-mitizodone-phosphate-tablets-in-the-treatment-of-patient-with-major-depressive-disorder-100438071","NCT04984512","The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder","A Phase II\u002FIII ,Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Adaptive Design Study Evaluating the Efficacy And Safety of Mitizodone Phosphate Tablets in the Treatment of Patient With Major Depressive Disorder","Inclusion Criteria:\n\n* 1.a Man or a woman with major depressive disorder(MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (classification code 296.22、296.23、296.32、296.33)\n* 2.Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.\n* 3.Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* 1.has major depressive disorder with psychotic features according to the DSM-5.\n* 2.Current or history of: bipolar disorder、schizophrenia、anixety disorder、insomnia、any substance abuse or dependence and other psychiatry disorder as defined in the DSM-5.\n* 3.Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).\n* 4\\. has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.\n* 5\\. Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).\n* 6\\. Current or history of angle-closure glaucoma.\n* 7\\. has made a suicide behavior in the previous 1 year ，or has a score greater than or equal to 4 on item 10 (suicidal thoughts) of MADRS .\n* 8.has taken fluoxetine within 4 weeks prior to initial dosing.\n* 9\\. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.\n* 10.has psychotherap at Screening and\u002For Baseline Visits.\n* 11.has had physiotherapy within 3 months prior to initial dosing.\n* 12.Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.\n* 13.Has an alanine aminotransferase, aspartate aminotransferase level greater than 2 times the upper limits of normal；or total bilirubin， direct bilirubin，creatinine level greater than 1.5 times the upper limits of normal；or a thyroid stimulating hormone value outside the normal range.\n* 14.Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.\n* 15.Has a history of severe allergies.",{"count":156,"type":22},[54,131],"This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of Mitizodone Phosphate.The dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.The target subjects are patients with MDD.",[28],"2026-04-29",{"date":249,"type":34},{"date":317,"type":34},"2021-12-14",{"date":319,"type":22},"2027-11",{"name":321,"class":145},"Sunshine Lake Pharma Co., Ltd.",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":42},"100285345","phase-1-nmda-receptor-antagonist-nitrous-oxide-targets-affective-brain-circuits-100285345","NCT02994433","NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits","Inclusion Criteria:\n\n* Adults 18-65 years of age\n* Right-handed\n* Controls: Not meet The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) by scoring ≤7 on the Hamilton Depression Rating Scale (HDRS), 17-item; Treatment-Resistant Major Depression (TRMD) patients: Must meet a ≥17 score on the HDRS.\n* Controls: Must not have any history of depression as determined by reported history and medical record review; TRMD: Documented (chart review) failure to respond to ≥3-4 adequate dose\u002Fduration antidepressant treatments; ≥1 in the current depressive episode.\n* Good command of the English language\n\nExclusion Criteria:\n\n* Meets criteria for any DSM-IV Axis I diagnosis as documented in medical records and as determined by structured clinical interview (except MDD for the TRMD group)\n* Known primary neurological disorders or medical disorders including dementia, stroke, encephalopathy Parkinson's Disease, brain tumors, multiple sclerosis, seizure disorder, severe cardiac or pulmonary disease\n* Any central nervous system active medication as determined by study investigator\n* Any known disease affecting drug metabolism and excretion (e.g. renal or liver disease) as determined by study investigator\n* Left-handedness\n* Not eligible for MRI scans (e.g. history of claustrophobia\u002Fimplanted metal as per MRI Screening Tool)\n* Current use of psychotropic medications, antidepressants, or prescription or non-prescription drugs\u002Fherbals intended to treat depression or anxiety (control group only)\n* Any recent (within past 12 months) history of substance dependence or abuse, determined by reported history or urine drug screen\n* Ability to become pregnant and not using effective contraception\n* Contraindication against the use of nitrous oxide:\n\n  1. Pneumothorax\n  2. Bowel obstruction\n  3. Middle ear occlusion\n  4. Elevated intracranial pressure\n  5. Chronic cobalamin and\u002For folate deficiency treated with folic acid or vitamin B12\n  6. Pregnant patients\n  7. Breastfeeding women\n* Inability to provide informed consent\n* Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic).",{"count":266,"type":22},[242],"Most clinical major depression responds to standard treatments (medication and psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond to these treatments and are referred to as treatment-resistant major depression (TRMD). New treatments for TRMD are needed, and one promising line of research are drugs known as N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, our group demonstrated that the NMDA antagonist nitrous oxide is effective in TRMD. This application proposes to take the next important step in understanding how nitrous oxide exerts its effects in the human brain by using state-of-the-art brain neuroimaging (functional connectivity magnetic resonance imaging) in a group of non-depressed, healthy volunteers and comparing the results to a group of TRMD patients.\n\nThis study involves exposing approximately 25 non-depressed healthy participants and 25 TRMD participants to nitrous oxide and a placebo gas, to compare their brain images before and after each of the inhalation sessions. Sessions will be separated by at least one month to prevent treatment effects from carrying over into the following session. All willing and eligible subjects will undergo up to six functional connectivity MRI scans, and two inhalation sessions. Functional imaging in the brain will allow us to trace the interconnections between various parts of the brain, including those involved with emotion and depression.\n\nOther procedures will involve screening materials to ensure safety of the participants before beginning the study (i.e. no MRI scan contraindications) and that subjects meet eligibility criteria to being in the targeted age range, depression\u002Fnon-depressed state, neurological disorder history, and no medication exclusions.",[28,58],"2026-04-24",{"date":314,"type":34},{"date":335,"type":34},"2017-01-27",{"date":337,"type":22},"2027-04-30",{"name":339,"class":41},"Washington University School of Medicine",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":97,"sex":17,"minAge":347,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":42},"100558115","bwell-d-pilot-randomized-controlled-trial-100558115","NCT06546917","bWell-D Pilot Randomized Controlled Trial","The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression","Inclusion Criteria:\n\n* 19-55 years old\n* Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD as assessed by a standardized psychiatric interview (SCID-5-RV) conducted by a trained clinician.\n* Patients will be euthymic or mildly depressed (defined by a Montgomery-Asberg Depression Rating Scale \\[MADRS\\] score \\\u003C 19)\n* Patients will report subjective cognitive deficits at baseline, as indicated by a total Perceived Deficits Questionnaire - Depression 20 \\[PDQ-D-20\\] score \\> 20 at study enrollment.\n* If using antidepressants, participants will be on stable antidepressant therapy for at least 4 weeks prior to randomization. All concomitant doctor-prescribed medications must be at a stable dose for 4 weeks prior to the randomization visit.\n* If undergoing psychotherapy, participants will be on stable adjunct psychotherapy for at least 8 weeks prior to randomization\n* If comorbid diagnosis of attention deficit hyperactivity disorder (ADHD), patients must be on stable dose of stimulants for at least 4 weeks prior to randomization.\n* Participants will be able to follow written and verbal instructions in English\n\nExclusion Criteria:\n\n* Moderate - severely depressed patients will be excluded at this point due to acceptability concerns (e.g. potential for cybersickness)\n* Presence of significant neurological disorders, head trauma, or other unstable medical conditions. These conditions may adversely impact cognitive functioning and influence study results.\n* Presence of other psychiatric disorder (e.g. anxiety, psychotic disorder) that may be considered primary.\n* Meeting DSM-5 criteria for alcohol or other substance use disorder within three months prior to the randomization visit.\\*\n* Use of benzodiazepine medications more than three times per week and\u002For within 24 hours of baseline or close out visit\n* Use of cannabis or alcohol within 24 hours, or tobacco within 30 minutes of baseline or close out visit\n* Suicidal ideation or self harm\n* Completion of previous cognitive remediation\n\nAdditionally, patients will be excluded from the study if they meet any of the following criteria due to contraindications with MRI scanning:\n\n* Retained wires from an electronic implant that has been removed (i.e. pacemaker wires not attached to a pacemaker)\n* Cardiac pacemaker or defibrillator\n* Metal in eye or orbit\n* Ferromagnetic aneurysm clip\n* Pregnancy\n* Makeup tattoos that are not designed to fade over time\n* Stainless steel intrauterine device (IUD)\n\nDepending on the individual situation, they MAY NOT be able to participate if they have\u002Fhad any of the following:\n\n* Artificial Heart Valve\n* Ear or eye implant\n* Brain aneurysm clip\n* Implanted electronic device (i.e. drug infusion pump, electrical stimulator)\n* Coil, catheter, or filter in any blood vessel\n* Orthopedic hardware (artificial joint, plate, screw, rod)\n* Shrapnel, bullets, or other metal fragments\n* Surgery, medical procedure or tattoos (including tattooed eyeliner) in the last six weeks\n* Other metallic prostheses\n\nIf the participant has any of the above, or any safety issues arise during MRI screening process, the individual case will be reviewed by UBC Hospital MR Technologist and\u002For Radiologist and a case-by-case decision will be made regarding participation.\n\nAdditionally, for the healthy participant recruitment, the eligibility criteria is as follows:\n\nInclusion Criteria for healthy controls:\n\n\\- 19-55 years old\n\nExclusion criteria for healthy controls:\n\n* History of any psychiatric disorder, as assessed by a standardized psychiatric diagnostic interview\n* Presence of significant neurological disorder, head trauma, or other unstable medical conditions which may adversely impact cognitive functioning\n* Presence of any physical mobility issues that limit arm or neck movement","19 Years","55 Years",{"count":350,"type":22},40,[25],"The goal of this clinical trial is to determine the acceptability, feasibility, and validity of the bWell Cognitive Care Platform for Depression (bWell-D), a novel Virtual Reality (VR) cognitive assessment and remediation tool, in depressed populations. The main questions are:\n\n* Do patients with Major Depressive Disorder (MDD) find the bWell-D cognitive assessment battery and protocol feasible, tolerable, and acceptable?\n* Do patients with Major Depressive Disorder (MDD) find the 8 week bWell-D remediation protocol feasible, tolerable, and acceptable?\n\nFollowing initial cognitive assessment, researchers will assess feasibility outcomes in the bWell remediation arm to a VR scenes experience arm to learn more about the feasibility of bWell for cognitive assessment and remediation.\n\nPatients will:\n\n* Complete an initial bWell cognitive assessment session\n* Randomized to either receive bWell cognitive remediation or a VR scenes experience twice a week for eight weeks\n* Complete cognitive\u002Ffunctional\u002Fclinical assessments and EEG at baseline, midpoint and endpoint of the remediation protocol, as well as two MRI scans and measures of tolerability, engagement, and enjoyment",[28,354],"Cognitive Dysfunction","2026-04-22",{"date":357,"type":34},"2026-04-28",{"date":359,"type":34},"2025-01-01",{"date":361,"type":22},"2026-08",{"name":363,"class":41},"University of British Columbia",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":372,"minAge":18,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":375,"conditions":376,"keywords":382,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":42},"100634507","mocha-embedded-inpatient-mental-health-care-for-high-risk-perinatal-patients-100634507","NCT07540585","MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients","MOCHA Protocol: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients","MOCHA","Inclusion Criteria:\n\n* 18 years old or older\n* Pregnant (or recently have given birth) at any gestational age\n* Must have experienced at least one adverse pregnancy outcome\n* Admitted for an extended inpatient stay\n* English speaking\n\nExclusion Criteria:\n\n* Under 18 years old\n* Not currently pregnant or past one year postpartum\n* Not experienced at least one adverse pregnancy outcome\n* Not admitted for an extended inpatient stay at RMT","FEMALE","100 Years",{"count":52,"type":22},"Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited. Project MOCHA integrates early mental health screening, trauma-informed psychotherapy, and structured follow-up into routine inpatient maternity care for individuals at elevated clinical risk.\n\nThis single-arm implementation study examines the feasibility, acceptability, and fidelity of delivering a Collaborative Mental Health Care Program within a high-risk obstetric inpatient setting. The program includes brief inpatient psychotherapy, symptom monitoring, and post-discharge follow-up over three months. Preliminary changes in depression, anxiety, attention-deficit hyperactivity disorder, and posttraumatic stress symptoms will be assessed to inform future effectiveness trials and broader health system integration.",[377,378,379,28,380,381],"Anxiety Disorders","Stress Disorders, Post-Traumatic","Pregnancy, High Risk","Pregnancy Complications","ADHD - Attention Deficit Disorder With Hyperactivity",[383,384,370,385,386,387],"Collaborative Mental Health Care Program","Inpatient high-risk pregnancy support","High-risk pregnancy mental health","Perinatal psychotherapy","Trauma-informed therapy","2026-04-18",{"date":355,"type":34},{"date":391,"type":22},"2026-06-01",{"date":393,"type":22},"2027-06-01",{"name":395,"class":41},"Indiana University",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":97,"sex":17,"minAge":403,"maxAge":179,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":302},"100586279","clinical-efficacy-safety-and-applicability-of-home-based-bright-light-therapy-in-outpatient-adolescents-with-major-depressive-disorder-100586279","NCT06913309","Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder","Clinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder in China: a Randomised Controlled Trial","The inclusion and exclusion criteria for MDD patients：\n\n1. inclusion criteria\n\n   * Meeting DSM-IV diagnostic criteria for a major depressive episode (first-episode or recurrent) , confirmed by two experienced, independent psychiatrists using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid);\n   * Aged 13-17 years ;\n   * Medication-naïve or on a stable pharmacological regimen for ≥1 week prior to enrollment;\n   * Baseline Hamilton Depression Rating Scale-17 (HAMD-17) score ≥14;\n   * Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;\n   * Voluntary participation with written informed consent provided by both participants and their legal guardians.\n2. exclusion criteria\n\n   * Current or past diagnosis of psychiatric disorders other than anxiety or sleep disorders;\n   * History of substance abuse or dependence history (including alcohol, nicotine, or illicit drugs);\n   * Baseline Young Mania Rating Scale (YMRS) total score ≥6;\n   * Received or planned to initiate non-pharmacological systemic interventions within 6 months prior to enrollment or within 1 month after enrollment, including but not limited to: structured psychotherapy (≥1 session\u002Fmonth for \\>6 months), physical therapy (e.g., modified electroconvulsive therapy \\[MECT\\], repetitive transcranial magnetic stimulation \\[rTMS\\], transcranial direct current stimulation \\[tDCS\\], or deep brain stimulation \\[DBS\\]), or exercise therapy ;\n   * Clinician-assessed suicide risk or a HAMD-17 item 3 score ≥3 at the baseline;\n   * Presence of severe systemic or neurological conditions, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;\n   * Severe retinal pathologies (e.g., retinal detachment, optic atrophy, macular degeneration); or having high myopia (spherical equivalent ≤ -6.00 diopters);\n   * Current use of photosensitizing agents or medications (e.g., chlorpromazine, hypericum extract);\n   * Any other condition deemed inappropriate by the investigators(e.g., cases involving severe sleep phase delays that make morning therapy impossible, or unrecorded photosensitivity).\n\nThe inclusion and exclusion criteria for Health controls\n\n1. Inclusion criteria\n\n   * Aged 13-17 years and right-handed;\n   * Minimum of 5 years of formal education, with the ability to complete clinical assessments and comprehend study-related information;\n   * Voluntary participation with written informed consent provided by both participants and their legal guardians.\n2. Exclusion criteria\n\n   * Current or lifetime diagnosis of any psychiatric disorders (e.g., schizophrenia, mood disorders, anxiety disorders) or history of substance\u002Fdrug abuse or dependence;\n   * First-degree family history of psychiatric disorders;\n   * Presence of severe systemic or neurological disorders, such as diabetes, hypertension, renal failure, hepatic dysfunction, thyroid disorders, encephalitis, traumatic brain injury, or epilepsy;\n   * Any other condition deemed inappropriate by the investigators.","13 Years",{"count":405,"type":22},168,[25],"Major Depressive Disorder (MDD) is a chronic disease characterized by a high prevalence, low cure rate, and significant disability. Globally, depression is recognized as the leading cause of illness and disability among children and adolescents. Bright light therapy (BLT) has been established as an effective treatment for seasonal affective disorder and has demonstrated considerable efficacy in adult patients with MDD. However, its application in adolescent patients with MDD remains largely unexplored. The aim of this clinical trial is to evaluate the clinical efficacy, onset time, safety, and applicability of BLT in adolescents with MDD and to explore the potential neural mechanisms by which BLT enhances emotional and cognitive function in this population. This is a multicenter, randomized, controlled, double-blind study. It will involve adolescents aged 13 to 17 who are either untreated or have been stable on medication for at least one week. Adolescents with MDD will be randomly assigned to one of three groups: a high-intensity bright white light intervention group, a medium-intensity bright white light intervention group, and a placebo control group receiving dim red light. Each group will undergo four weeks of light exposure, six days per week, for 40 minutes daily between 6:30 and 10:00 AM. During the light exposure period, follow-up assessments will be conducted every weekend, and participants will be followed for two weeks after the completion of light exposure.The primary outcome will be the change in total scores on the 17-item Hamilton Rating Scale for Depression (HAMD-17) from baseline to week 4. Secondary outcomes will include response and remission rates, time to onset, maintenance of efficacy, self-reported depressive symptoms, sleep quality, cognitive function, anxiety, irritability, suicidal ideation, non-suicidal self-injury, self-efficacy, and the overall safety profile of BLT.\n\nAdditionally, the study will include healthy adolescent controls and collect functional Near-Infrared Spectroscopy (fNIRS) from both the adolescent participants with major depressive disorder and the healthy controls at baseline. The fNIRS and MRI data will also be collected from the adolescent participants with MDD at the end of the intervention, in order to investigate the potential neural mechanisms by which light therapy alleviates depressive symptoms in adolescents.",[28],[410,411,412,413,414],"Depressive Disorder，Major","Bright Light Therapy","Adolescent","Neural Mechanisms","Randomised Controlled Trial","2026-04-16",{"date":417,"type":34},"2026-04-21",{"date":419,"type":34},"2025-03-17",{"date":421,"type":22},"2026-06-30",{"name":423,"class":41},"Peking University Sixth Hospital",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":42},"100509118","dopamine-modulation-of-motivation-and-motor-function-in-major-depression--inflammation-100509118","NCT05909267","Dopamine Modulation of Motivation and Motor Function in Major Depression & Inflammation","Effects of Pharmacological Dopamine Modulation on Motivation and Motor Function in Major Depression Characterized by Low-grade Inflammation.","MOTIVADE","Inclusion Criteria:\n\nFor patients with major depressive disorder:\n\n* diagnosis of major depressive disorder according to DSM-5\n* free of antidepressant medication\n\nFor healthy participants:\n\n* C-reactive protein (CRP): ≤ 1 mg\u002Fl\n* free of antidepressant medication\n* free of any current psychiatric disorder\n\nExclusion Criteria:\n\n* diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, dementia, and current\u002Fpast alcohol or drug dependence\n* central nervous system diseases\n* neurological diseases\n* suspicious undiagnosed skin lesions or a history of melanoma\n* narrow-angle or wide-angle glaucoma\n* bronchial asthma\n* history of peptic ulcer disease\n* history of seizures\n* any severe somatic disease\n* current infections or chronic inflammatory diseases (e.g., rheumatic diseases, inflammatory bowel disease)\n* pregnancy \u002F breast-feeding\n* class 3 obesity (body mass index of 40 or higher)\n* Use of medication containing reserpine (certain antihypertensive agents), tricyclic antidepressants, bon-selective monoamine oxidase (MAO) inhibitors, antiparkinsonian drugs, sympathomimetic drugs, tetrabenazine.",{"count":433,"type":22},165,[25],"A large body of evidence on depression heterogeneity point to an \"immunometabolic\" subtype characterized by the clustering of immunometabolic dysregulations with atypical behavioral symptoms related to energy homeostasis. Motivational and motor impairments reflected by symptoms of anhedonia and psychomotor retardation in major depression are closely related to alterations in energy homeostasis, are associated with increased inflammation, and may be a direct consequence of the impact of inflammatory cytokines on the dopamine system in the brain. In the proposed project, the investigators will examine the effect of dopamine stimulation on motivation and motor function in patients with major depression and healthy controls and the role of inflammation using a double-blind, randomized, placebo-controlled, cross-over design. If successful, this study would provide crucial evidence that pharmacologic strategies that increase dopamine may effectively treat inflammation-related symptoms of anhedonia and psychomotor retardation in major depression.",[28],[438,439,440,441],"depression","inflammation","anhedonia","psychomotor retardation","2026-03-16",{"date":444,"type":34},"2026-03-18",{"date":446,"type":34},"2023-07-26",{"date":36,"type":22},{"name":449,"class":41},"Charite University, Berlin, Germany",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":302},"100508526","acupuncture-and-escitalopram-for-treating-major-depression-clinical-study-100508526","NCT05901571","Acupuncture and Escitalopram for Treating Major Depression Clinical Study","Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial","AE-TMDCS","Inclusion Criteria:\n\n1. Between 18 and 75 years of age with no gender-based restriction.\n2. Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.\n3. A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17\n4. Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.\n5. The absence of acupuncture treatment within at least 1 year.\n6. Willingness to participate in the trial and provide written informed consent for the clinical trial.\n\nExclusion Criteria:\n\n1. Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.\n2. High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.\n3. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.\n4. Pregnancy or breastfeeding.\n5. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.\n6. Candidates afraid of needles in general and reluctant to receive acupuncture in particular\n7. Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).\n8. Previous participation in other acupuncture trials.",{"count":459,"type":22},216,[25],"We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.",[28],"2026-03-09",{"date":465,"type":34},"2026-03-11",{"date":467,"type":22},"2026-11",{"date":469,"type":22},"2030-02",{"name":471,"class":41},"Shanghai 7th People's Hospital",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":42},"100407167","biomarkers-of-depression-and-treatment-response-100407167","NCT04581902","Biomarkers of Depression and Treatment Response","SUNSET","Inclusion Criteria:\n\n* Age 18-70\n* Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without psychotic features.\n* Has Montgomery-Asberg Depressive Rating Scale (MADRS) of \\> 19 at baseline, corresponding with moderate to severe depression.\n* Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.\n* If participant is on a regimen of psychotropic medication, no changes in this regimen should be made during the period between the time at which pre-treatment and post-treatment scans are taken.\n* Willing and able to undergo non-invasive brain stimulation\n* Willing and able to attend research visits for approximately 8 weeks\n* Willing and able to provide informed consent\n* Ability to speak and read English\n\nExclusion Criteria:\n\n* Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode.\n* Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.\n* Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.\n* Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.\n* Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, as determined by the SCID\n* History of seizures\n* Implantable hardware not compatible with MRI or with the study\n* Inability to comply with study daily visits\n* Women who are pregnant, plan to become pregnant, or breast feeding\n* Inability to speak and\u002For read English\n* Inability to give consent\n* Any active suicidal intent or plan during the current depressive episode, as determined by a score of 3 on Question #9 of Beck's Depression Inventory (scores reviewed daily by study team members versed in scoring clinical scales), or as by a subjective determination by a study clinician during any study visit.",{"count":52,"type":22},[25],"This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.",[28],[484,438,485,486,487,488],"transcranial magnetic stimulation","biomarker","TMS","neuroimaging","rTMS","2026-01-28",{"date":491,"type":34},"2026-01-30",{"date":493,"type":34},"2020-12-01",{"date":495,"type":22},"2027-09",{"name":497,"class":41},"University of California, San Francisco",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":42},"100481772","dosing-rtms-for-depression-post-sci-100481772","NCT05553353","Dosing rTMS for Depression Post-SCI","Evaluating a Novel Method to Determine the rTMS Dose Needed for Treating Depression After Spinal Cord Injury","Inclusion Criteria:\n\n* cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D;\n* 18 - 60 years of age;\n* major depressive disorder, as identified by Structured Clinical Interview for DSM-V;\n* Hamilton Depression Rating Scale-17 score \\> 18;\n* not taking antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks before the study (6 weeks if newly initiated medication)\n\nExclusion Criteria:\n\n* concomitant neurologic diseases\u002Fdisorders or dementia;\n* cognitive impairment (Montreal Cognitive Assessment \\\u003C17);\n* history of psychosis or other Axis I disorder that is primary;\n* positive screen for bipolar disorder through the Mini-International Neuropsychiatric Interview;\n* history of claustrophobia;\n* life expectancy \\\u003C1 year;\n* electronic or metallic implants (i.e., metal in the head, cochlear implant, or pacemaker;\n* history of seizures or currently prescribed anti-seizure medications;\n* taking medication that increases the risk of seizures;\n* pregnancy as identified through a positive urine pregnancy test;\n* Hamilton Depression Rating Scale-17 question #3 regarding suicide: \\>2 or suicide attempt within the previous two years;\n* inability to (University of California, San Diego Brief Assessment of Capacity to Consent) or declined to give informed consent.",{"count":506,"type":22},24,[25],"Depression is a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression, but dosing is based on a motor response or movement in the thumb. Over half of individuals with SCI have some degree of arm or hand impairment, so these individuals might not be eligible for rTMS, or they may receive the wrong dose. This study proposes clinical trial in individuals with depression post-SCI to assess the anti-depressant effect of a novel technique to dose rTMS that does not require a motor response in the thumb. By gaining a better understanding of the application of rTMS for depression post-SCI, the investigators aim to advance the rehabilitative care of Veterans.",[510,65,28],"Spinal Cord Injuries",[510,65,28,512],"Transcranial Magnetic Stimulation","2026-01-13",{"date":515,"type":34},"2026-01-14",{"date":517,"type":34},"2025-03-31",{"date":519,"type":22},"2027-10-29",{"name":521,"class":522},"VA Office of Research and Development","FED",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":536,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":42},"100527818","comparing-the-efficacy-of-fmri-guided-vs-standard-itbs-in-treating-depression-100527818","NCT06152705","Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression","Triple-blind Randomized Trial Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression","Inclusion criteria:\n\nFor inclusion in the study, participants must fulfill all the following criteria:\n\n1. voluntary and competent to consent to study,\n2. Adults aged 18 years old or older,\n3. can speak and read English,\n4. primary and\u002For predominant diagnosis of major depressive episode without psychotic features in the current episode (confirmed by a Mini-International Neuropsychiatric Interview),\n5. depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,\n6. moderate symptoms in the current depressive episode as indexed by a score of at least 15 on the Grid 17-item Hamilton Rating Scale for Depression (Grid HRSD-17),\n7. have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,\n8. are able to adhere to treatment schedule,\n9. have stable psychotropic medications (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,\n10. have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if they are aged ≥ 65.\n\nExclusion criteria:\n\nParticipants fulfilling any of the following criteria will be excluded from the study:\n\n1. diagnosis of bipolar I or II disorder, based on the DSM-5 criteria\n2. current or past (\\\u003C 3 months) substance (excluding caffeine or nicotine) or alcohol use disorder, as defined in DSM-5 criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use disorder would be permissible in the past 3 months, moderate to severe would be an exclusion.\n3. current use of illegal substances or cannabis (unless medical use, see note below), confirmed by urine drug screen\n4. have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),\n5. organic cause to the depressive symptoms (e.g. thyroid dysfunctions), as ruled out by the referring physician\n6. acute suicidality or threat to life from self-neglect,\n7. are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment (pregnancy will be assessed by a urine test),\n8. have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),\n9. unwilling to maintain current antidepressant regimen,\n10. are taking more than 1 mg of lorazepam per day or equivalent,\n11. any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,\n12. any contraindications for MRI\n13. have failed a course of ECT within the current depressive episode due to the lower likelihood of response to rTMS (if they have had failed ECT in the past, this does not exclude them)",{"count":531,"type":22},210,[25],"In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.",[65,28,535],"Depressive Episode",[537,538,539],"fMRI","iTBS","neuronavigation","2025-12-09",{"date":542,"type":34},"2025-12-17",{"date":544,"type":34},"2024-09-16",{"date":546,"type":22},"2027-10-01",{"name":548,"class":41},"The Royal Ottawa Mental Health Centre",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":42},"100569095","a-mobile-health-intervention-to-improve-psychosocial-functioning-in-veterans-with-posttraumatic-stress-disorder-and-depression-symptoms-100569095","NCT06689787","A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms","Inclusion Criteria:\n\n* Veteran\n* enrolled in VA care\n* fluent in English\n* able to provide informed consent\n* own a smartphone or willing to use a study-provided smartphone\n* have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD)\n* willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study\n\nExclusion Criteria:\n\n* history of mania or psychosis\n* current suicidal ideation with plan and intent to harm self\n* acute intoxication from alcohol or other substances\n* current or past experience with any form of STAIR",{"count":350,"type":22},[25],"Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.",[559,378,28],"Psychosocial Functioning",[561,562],"Veterans","Mobile Applications","2025-10-27",{"date":565,"type":34},"2025-10-29",{"date":567,"type":22},"2027-04-01",{"date":569,"type":22},"2029-04-01",{"name":521,"class":522},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":586,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":42},"100477021","acceptability-and-feasibility-of-work-oriented-social-cognitive-skills-training-for-veterans-with-serious-mental-illness-100477021","NCT05491538","Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness","Acceptability and Feasibility of Work-Oriented, Veteran-Centric, Social-Cognitive Skills Training","Inclusion Criteria:\n\n* Veterans who are outpatients and enrolled to receive supported services at the Minneapolis VA Health Care System.\n* Veterans are eligible for this program if they are receiving services from a mental health team at the Minneapolis VA Health Care System, are motivated to pursue employment, and are seeking employment within 30 miles of the medical center.\n* Veterans will be eligible for the study if they have a DSM-5 diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, Bipolar II Disorder, Recurrent Major Depressive Disorder, or PTSD.\n\nExclusion Criteria:\n\nStudy exclusion criteria are:\n\n* presence of a moderate or severe traumatic brain injury\n* presence of a cognitively compromising neurological disease\n* understanding of English that is not sufficient for comprehension of testing procedures\n* premorbid IQ less than 70\n* behavior that prevents participation in a group intervention\n* hearing or visual impairment that prevents completion of intervention and testing procedures\n* clinical instability, defined as active suicidal ideation or hospitalization in the previous 4 weeks\n* current diagnosis of alcohol or substance use disorder, severe\n* current participation in another mental health intervention study\n* inability to commit to 7-9 months of study participation due to a planned move or unstable housing\n* inability to provide informed consent\n* presence of a guardian of person",{"count":579,"type":22},20,[25],"Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. The goals of this study are to: 1) adapt an evidence-based social cognitive skills intervention for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes.\n\nThe current study will use feedback from veteran and employment specialist stakeholders to adapt an evidence-based social cognitive skills training program, Social Cognition and Interaction Training (SCIT). The intervention will be modified to tailor it to work relationships and to address any unique relationship concerns among Veterans that are identified by stakeholders. SCIT-Work Edition (SCIT-WE) will add: 1) education about work-related social norms; 2) examples of work-related social interactions that require perspective taking and problem- solving; 3) individual sessions with the study therapist to enhance learning and relevance to each participant's goals; 4) structured interactions with the participant's employment specialist to practice skills outside of group; and 5) skill application sessions with the participant's employment specialist that prompt use of skills after training is completed.\n\nSCIT-WE will be developed and piloted in an open trial with 20 Veterans enrolled in the supported employment program at the Minneapolis VA who have a qualifying serious mental illness diagnosis. SCIT-WE will be offered for 2 hours weekly over 13 weeks, when most participants are in the job development and job search phases of supported employment. While participating in the group skills training, participants will have weekly, individual homework review sessions with the group facilitator to promote understanding of the skills and to discuss relevance of the skills to personal goals. Participants also will practice skills weekly with their employment specialist for 10-15 minutes to promote use of skills outside of group sessions. In the 3-months following skills training completion, participants will complete 10 15-minute skills review sessions with their employment specialist to encourage continued skill application in a work setting.\n\nParticipants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. The investigators predict that Veterans will report being productive and having positive work relationships 6-months post-enrollment.\n\nThe findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.",[583,584,28,585],"Schizophrenia","Bipolar Disorder","Stress Disorder, Post-Traumatic",[587,588,589,590],"social cognition","employment, supported","psychotherapy, group","mental health","2025-10-08",{"date":593,"type":34},"2025-10-09",{"date":595,"type":34},"2022-12-01",{"date":597,"type":22},"2027-11-30",{"name":521,"class":522},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":605,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":616,"leadSponsor":618,"locationsCount":42},"100487698","prediction-of-antidepressant-effects-of-electroconvulsive-therapy-100487698","NCT05630469","Prediction of Antidepressant Effects of Electroconvulsive Therapy","Inclusion Criteria:\n\n* male or female inpatients (18-65 years old)\n* ICD-10 diagnosis of severe unipolar depression (F32.2, F32.3, F33.2, F33.3)\n* HAMD17 ≥ 23\n* physical health\n* ability to understand and willingness to sign the written informed consent document\n* negative drug screening, negative urine pregnancy test in women\n* antidepressant and antipsychotic medication in steady state for at least 10 days prior inclusion\n* anesthesiological approval for ECT\n\nExcusion criteria:\n\n* severe somatic or neurological disease\n* current comorbid psychiatric disorder, including bipolar depression (according to DSM-5)\n* current or past history of schizophrenia or schizoaffective disorder\n* current use of alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet DSM-5 criteria for alcohol or other substance dependence\n* clinically relevant abnormalities on a general physical examination and routine laboratory screening\n* pregnancy, breast feeding\n* contraindications to lumbar puncture (increased intracranial volume, anticoagulant medication, uncorrected bleeding diathesis, coagulopathy, congenital spine abnormality, recent spinal trauma\u002Fsurgery, skin infection at puncture site)\n* any implant or stainless steel graft contraindicated for MRI",{"count":606,"type":22},30,"Despite its successful use for more than 80 years, the mechanisms of action of electroconvulsive therapy (ECT) are still not fully understood. ECT has been shown to be accompanied by changes in regional brain volumes and connectivity measures, as well as biochemical alterations. However, how these changes relate to ECT response remains to be further elucidated; up to now, there are no objective markers for the targeted use of ECT in clinical practice.\n\nMethods: Study design: longitudinal mono-centre study with duration of 36 months. Subjects: 30 depressed patients (aged 18-65 years) eligible for ECT. Measurements: subjects will undergo 2 3-Tesla MRI scans (one before and one after a course of ECT), including structural MRI, resting-state functional MRI, task-based functional MRI and MR spectroscopy. Blood, CSF sampling and clinical assessments will be performed once before and once after the ECT course. ECT: Each patient will be treated in a min. of 8 bitemporal ECT sessions (\\~4 weeks). Data analysis: Longitudinal changes in brain imaging parameters and laboratory measures (before\u002Fafter ECT) will be assessed using repeated-measures analysis of covariance. Machine learning with random forests will be employed to identify a pattern of pretreatment imaging, biochemical (serum and CSF) and clinical parameters that are best qualified to predict response to ECT as defined by a reduction of ≥50% of baseline HAMD17.\n\nHypotheses: 1. ECT will be accompanied by changes in brain morphology, functional connectivity, neuronal activation in response to cognitive and reward-related stimuli and neurochemical signals in the brain. 2. ECT leads to changes in blood- and CSF-based markers of neuronal plasticity, neurodegeneration and inflammation, as well as genetic\u002Fepigenetic markers. 3. Predictive markers of ECT response can be established based on the relationships between imaging, neurochemical and clinical markers and treatment response.\n\nInnovation: This study would be the first to combine multimodal MRI measures with the assessment of biomarkers in the CSF in the context of ECT. The implementation of the proposed trial represents an important step towards a better understanding of the powerful antidepressant properties of ECT. By relating treatment effects and potentially underlying biological mechanisms on numerous complementary levels, the study might help to identify biomarkers that distinguish patients who are likely to benefit from ECT from non-responders. Ultimately, results of the study might be useful in order to establish an individualized medical indication for ECT.",[28],[610,487,611,485],"electroconvulsive therapy","response prediction","2025-09-22",{"date":614,"type":34},"2025-09-25",{"date":595,"type":34},{"date":617,"type":22},"2026-11-30",{"name":619,"class":41},"Medical University of Vienna",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":239,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":630,"briefSummary":631,"conditions":632,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":639,"locationsCount":42},"100597495","the-motor-activity---subjective-energy-mase-project-100597495","NCT07059234","The Motor Activity - Subjective Energy (MASE) Project","The Motor Activity - Subjective Energy (MASE) Project: Neurobiological and Digital Phenotyping Towards Digital Mental Health Interventions in Depression","MASE","Inclusion Criteria:\n\n* Sufficient knowledge of the German language\n* Written informed consent.\n* Score \\> 15 on the Montgomery Asberg Depression rating scale (MADRS) for MDD group.\n* Remission within the past year and exhibit a MADRS score \\\u003C 10 for at least one month for rMDD group\n\nExclusion Criteria:\n\n* Pregnancy at baseline\n* Claustrophobia\n* Pacemaker\n* Artificial heart valves\n* Active implants\n* Other psychiatric disorders\n* Acute suicidality, change of medication \u002F psychotherapy during the intervention (not dosage but substance).\n* For healthy participants: history of any mental health condition or first-degree relative with affective \u002F psychotic disorder",{"count":629,"type":22},180,[25],"This approach utilizes accelerometry to measure NEA and electronic diaries for real-time psychological assessments, overcoming limitations of traditional methods such as retrospective bias and low ecological validity. Brief episodes of physical activity in daily life, which are distinctly different from structured exercise sessions, are generally linked to improved affective well-being. Notably, feelings of energy are particularly associated with incidental, unstructured, and non-exercise activities. Clinically, psychomotor retardation and diminished mood are key diagnostic features of MDD, with evidence suggesting that lower motor activity differentiates MDD patients from controls and that increased activity correlates with treatment response. In this context, the MASE project aims to design personalized BA interventions that focus on increasing NEA and, in turn, enhancing subjective energy levels to reduce depressive symptoms and prevent relapse.",[28],"2025-09-09",{"date":635,"type":34},"2025-09-16",{"date":637,"type":34},"2025-09-02",{"date":337,"type":22},{"name":640,"class":41},"University of Bern"]