[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mdd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mdd":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,49,85,115,137,160,173,195,222,250,274,297,325,349,375],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053248","neural-derived-plasma-exosomal-micrornas-as-promising-novel-biomarkers-for-suicidality-and-treatment-outcome-in-adolescents-100053248",false,"NCT05437588","Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents","Inclusion Criteria:\n\nAll participants:\n\n1. Physically healthy\n2. willing and able to provide informed consent (if under 18 also parent or guardian consent)\n\nMDD participants:\n\n1. A definite diagnosis of DSM-5\n2. a Children's Depression Rating Scale-Revised (CDRS-R) score \\>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \\>=4 rated over the last two weeks.\n\nSuicide attempt group:\n\n1\\. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale.\n\nNon-psychiatric controls:\n\n1\\. No history of any major mental illness (excluding specific phobia) or substance use disorder.\n\nExclusion Criteria:\n\n* Exclusion criteria:\n\n  1. Pregnancy or lactation\n  2. post-partum state (being within 2 months of delivery or miscarriage);\n  3. homicide risk as determined by clinical interview\n  4. any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine\u002Fcaffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.\n  5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months\n  6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.",true,"ALL","10 Years","24 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.",[27,28,29,30,31,32,33,34,35],"Major Depressive Disorder","Suicidal Ideas","Suicide, Attempted","MDD","Depression","Depression, Teen","Depression and Suicide","Depression in Adolescence","Suicide","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2022-10-01",{"date":44,"type":21},"2027-06-30",{"name":46,"class":47},"University of Alabama at Birmingham","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100054040","phase-2-inhaled-dmt-for-major-depressive-disorder-100054040","NCT07562191","Inhaled DMT for Major Depressive Disorder","Randomized, Double-Blind, Placebo-Controlled Phase IIb Trial of Inhaled N,N-Dimethyltryptamine (DMT) for Major Depressive Disorder","DMT-MDD","Inclusion Criteria:\n\n* 18 years or older, capable of making decisions, and able to provide informed consent.\n* Major Depressive Disorder (MDD) according to DSM-5 criteria\n* Current depressive episode of moderate to severe intensity\n* Episode duration of at least two weeks\n* Baseline MADRS score ≥ 20\n* No treatment changes (including antidepressants) in the 4 weeks prior to the study\n* Abstain from psychedelics ≥14 days before dosing (D0)\n\nExclusion criteria:\n\n* Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions\n* Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma\n* Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma\n* Neurological risk (e.g., aneurysm, ↑ICP, epilepsy\u002Fseizures, severe disorders)\n* MAO deficiency or history of serotonin syndrome\n* Pregnant, breastfeeding, positive test, or no effective contraception\n* Secondary depression\n* Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport\n* Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis\u002Fbipolar disorder\n* Mania\u002Fhypomania\n* OCD, dissociative disorders, active PTSD, or decompensated eating disorders\n* Moderate-severe use disorder (past 6 months; except nicotine\u002Fcaffeine)\n* Lifetime ketamine, PCP, psychedelics, or MDMA use disorder\n* Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing\n* Psychedelic trial participation in past 12 months\n* Cognitive impairment affecting valid assessment","18 Years",{"count":59,"type":21},140,[61],"PHASE2","This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD).\n\nThe study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT.\n\nParticipants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.",[30,64,65,66,35],"Major Depressive Disorder (MDD)","Major Depression","Suicidal Ideation",[68,69,70,71,72,73,74,75],"DMT","major depressive disorder","N,N-dimethyltryptamine","psychedelic therapy","inhaled DMT","vaporized DMT","suicidality","non invasive","2026-07-09",{"date":39,"type":40},{"date":79,"type":21},"2026-08-01",{"date":81,"type":21},"2027-08-01",{"name":83,"class":47},"Universidade Federal do Rio Grande do Norte",5,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100601507","feasibility-of-home-based-intermittent-60hz-light-therapy-for-major-depressive-disorder-mdd-100601507","NCT07111390","Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)","A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression","Inclusion Criteria:\n\n* Age between 24 and 65 years (inclusive)\\*.\n* Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview.\n* Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening.\n* On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening.\n* No evidence of premorbid cognitive impairment, as demonstrated by a standard score \\>85 on the WRAT-5 Reading Recognition Subtest.\n* Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms.\n* Able to provide informed consent and comply with study procedures.\n* Access to a quiet space suitable for home-based light stimulation sessions.\n* English speaking: All study materials and assessments are only validated in English\n\nExclusion Criteria:\n\n* Presence of primary neurological or autoimmune disorders.\n* Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder).\n* Current or recent diagnosis of alcohol or substance use disorder.\n* History of bipolar disorder or any psychotic disorder.\n* Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).\n* History of seizure disorder or epilepsy.\n* History of migraine, tinnitus, or photosensitivity.\n* Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure.\n* Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).\n* Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding","65 Years",{"count":94,"type":21},40,[24],"This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.",[31,30,27,98],"Major Depressive Episode",[100,30,31,101,102,103,104],"Brain stimulation","Light therapy","Wearable","Neuromodulation","Telehealth","2026-06-25",{"date":107,"type":40},"2026-06-29",{"date":109,"type":40},"2025-08-18",{"date":111,"type":21},"2027-02-01",{"name":113,"class":47},"NYU Langone Health",1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":92,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":114},"100636964","tdcs-sleep-to-mood-in-depression-s2m-d-100636964","NCT07572526","tDCS: Sleep to Mood in Depression (S2M-D)","Sleep Consolidation as a Mechanistic Pathway Linking Home-Based tDCS to Antidepressant Response (S2M-D)","Inclusion Criteria:\n\n1. Ability to read and understand study materials in English, as demonstrated by a standard score \\>85 on the WRAT-5 Reading Recognition Subtest\n2. MADRS-S ≥18 during screening\n3. Confirmed diagnosis of MDD, based on clinician interview\n4. If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening.\n5. Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms OR confirmed acknowledgement and identification of local resources.\n6. Able to provide informed consent and comply with study procedures.\n7. Access to a quiet space suitable for home-based tDCS stimulation sessions.\n\nExclusion Criteria:\n\n1. Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes.\n2. Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening.\n3. Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).\n4. Use of prescription or over-the-counter sleep-promoting medications or initiation of behavioral interventions specifically targeting sleep in the past 30 days from pre-screening.\n5. History of seizure disorder or epilepsy.\n6. Presence of an active implanted medical device above the neck (e.g., deep brain stimulator, cochlear implant) or non-MRI-compatible metallic implants in the head or neck region.\n7. Current use of prescription or over-the-counter sleep medications, or active participation in any behavioral or pharmacologic treatment specifically targeting sleep.\n8. Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding o If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.",{"count":123,"type":21},35,[24],"The purpose of this study is to determine whether changes in sleep consolidation occur during home-based transcranial direct current stimulation (tDCS) in adults with moderate depression and whether these changes are temporally associated with improvements in depressive symptoms.",[27,30,31,98],[30,100,31,128,103,102,104],"tDCS","2026-06-05",{"date":131,"type":40},"2026-06-08",{"date":133,"type":40},"2026-06-04",{"date":135,"type":21},"2027-12-31",{"name":113,"class":47},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100643531","functional-electrical-stimulation-for-mdd-100643531","NCT07629050","Functional Electrical Stimulation for MDD","Functional Electrical Stimulation for Major Depressive Disorder: A Pilot Randomized Control Trial","Inclusion Criteria:\n\nPatients will be included if they:\n\n1. Meet the DSM-5 criteria for unipolar MDD with a current MDE without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), validated by MINI done by a trained research assistant.\n2. Have no change in the medication regimen or other forms of treatments (e.g., psychotherapy) for at least 4 weeks (28 days) prior to beginning the study, and have no plan to change them during the 20-session treatment period (14 days), and the 4-week post-treatment observation period. This will be established through self-report, in combination with the ATHF filled out by the participant.\n3. Have an MDD diagnosis as confirmed by the MADRS score of ≥7.\n4. Age group between 18 and 70 years of age\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n1. History of epilepsy or seizures.\n2. Damage or dysfunction of facial nerves.\n3. Metallic orthopedic implants in the mouth (e.g., plates or screws).\n4. Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening.\n5. History of treatment-resistant depression (TRD) with history of ECT, Magnetic Seizure Therapy, Intravenous Ketamine use in the past or failure of \\>2 antidepressant treatments of adequate duration and dose during the current episode.\n6. Past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder, active substance abuse or dependence (excluding nicotine and caffeine), neurodegenerative disease, or dementia. This will be confirmed on the MINI (77) administered by a trained research assistant.\n7. Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10.\n8. Unable to understand instructions in English.\n9. Unable to produce \"Duchenne marker\" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.","70 Years",{"count":146,"type":21},60,[24],"This study aims to determine whether Functional Electrical Stimulation (FES) of the facial muscles is a safe and effective treatment for major depressive disorder (MDD).",[30],[27,151],"Functional Electrical Stimulation","NOT_YET_RECRUITING",{"date":131,"type":40},{"date":155,"type":21},"2026-05-25",{"date":157,"type":21},"2029-03-30",{"name":159,"class":47},"Unity Health Toronto",{"id":161,"slug":4,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":62,"conditions":165,"keywords":166,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":171,"leadSponsor":172,"locationsCount":84},"100636169","Inclusion Criteria:\n\n* 18 years or older, capable of making decisions, and able to provide informed consent.\n* Major Depressive Disorder (MDD) according to DSM-5 criteria\n* Current depressive episode of moderate to severe intensity\n* Episode duration of at least two weeks\n* Baseline MADRS score ≥ 20\n* No treatment changes (including antidepressants) in the 4 weeks prior to the study\n* Abstain from psychedelics ≥14 days before dosing (D0) and during the 12-month follow-up\n\nExclusion criteria:\n\n* Major cardiac, hepatic, or renal disease; unstable cardiovascular conditions\n* Uncontrolled hypertension, QTc prolongation, arrhythmias, or valvular disease COPD or asthma\n* Severe obesity, uncontrolled diabetes, coagulopathy, thyroid disease, or glaucoma\n* Neurological risk (e.g., aneurysm, ↑ICP, epilepsy\u002Fseizures, severe disorders)\n* MAO deficiency or history of serotonin syndrome\n* Pregnant, breastfeeding, positive test, or no effective contraception\n* Secondary depression\n* Cluster B personality disorders (incl. borderline with ≥2 suicidal behaviors in past 12 months) or poor therapeutic rapport\n* Psychotic disorders, MDD with psychotic features, or first-degree family history of psychosis\u002Fbipolar disorder\n* Mania\u002Fhypomania (YMRS ≥8)\n* OCD, dissociative disorders, active PTSD, or decompensated eating disorders\n* Moderate-severe use disorder (past 6 months; except nicotine\u002Fcaffeine)\n* Lifetime ketamine, PCP, psychedelics, or MDMA use disorder\n* Current use of MAO inhibitors, unless discontinued at least 14 days prior to dosing\n* Psychedelic trial participation in past 12 months\n* Cognitive impairment affecting valid assessment",{"count":59,"type":21},[61],[30,64,65,66,35],[68,69,70,71,72,73,74,75],"2026-05-22",{"date":169,"type":40},"2026-05-28",{"date":79,"type":21},{"date":81,"type":21},{"name":83,"class":47},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":92,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":114},"100579791","phase-2-dose-finding-clinical-trial-to-evaluate-the-efficacy-and-safety-of-lv232-capsules-in-the-treatment-of-mdd-100579791","NCT06828887","Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD","Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of Major Depressive Disorder (MDD)","Inclusion Criteria:\n\n1. Fully understand the purpose, content, and potential adverse reactions of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, able to complete the entire trial process as required and comply with the trial regulations;\n2. Gender unrestricted, at screening: 18 years old ≤ age ≤ 65 years old;\n3. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression according to the Mini International Neuropsychiatric Interview (M.I.N.I. 7.0.2), currently experiencing a single or multiple episodes;\n4. For first-episode patients, the duration of the current depressive episode must be ≥3 months; for recurrent patients, the duration of the current depressive episode must be ≥1 month (each month is counted as 30 days, the same applies below);\n5. During the screening and baseline periods, the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) must be ≥26, and the Clinical Global Impression-Severity (CGI-S) score must be ≥4;\n6. At screening and baseline visits, the score on the first item (depressed mood) of the HAMD-17 scale must be ≥2;\n7. Female or male subjects of childbearing potential agree and commit to using effective contraception from the signing of the informed consent form until 3 months after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Treatment-resistant depression (failure to respond to an adequate dose and duration of treatment, at least 8 weeks, with two antidepressants of different mechanisms) or failure to respond to an adequate dose and duration of treatment with escitalopram oxalate;\n2. Meeting the diagnostic criteria for other mental disorders as per DSM-5 (such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, generalized anxiety disorder, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc.);\n3. Meeting the DSM-5 criteria for substance use disorder;\n4. Organic mental disorders, such as depression caused by hypothyroidism;\n5. Depression induced by psychoactive substances or non-addictive substances;\n6. Presence of depressive symptoms due to other diseases or other types of mental disorders;\n7. A reduction of ≥25% in the MADRS score at baseline compared to the screening period;\n8. Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) and judged by the investigator to be at risk of suicide, or having suicidal behavior within the 6 months prior to screening;\n9. Presence of severe physical illnesses deemed by the investigator as grounds for exclusion, such as uncontrolled hypertension or severe unstable cardiovascular diseases, severe liver diseases, kidney diseases, blood diseases, endocrine diseases, neurological diseases, etc.;\n10. Diseases affecting oral drug absorption, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc.;\n11. Active malignancy or a history of malignancy within 5 years prior to screening (except for completely resected and cured squamous cell carcinoma, cervical carcinoma in situ, etc.);\n12. History of increased intraocular pressure or narrow-angle glaucoma;\n13. Individuals with allergic constitution, such as those allergic to two or more drugs or known to be allergic to escitalopram oxalate;\n14. Use of drugs that alter the activity of liver enzymes (CYP2C19 and CYP2D6) within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization (see Appendix 2);\n15. Previous treatment with vagus nerve stimulation (VNS) and deep brain stimulation (DBS), or modified electroconvulsive therapy (MECT) within 3 months prior to randomization, or systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy), transcranial magnetic stimulation (TMS), and light therapy within 1 month prior to randomization, or judged by the investigator to currently require such treatments;\n16. Systematic antidepressant treatment within 2 weeks prior to randomization (not less than 30 days for fluoxetine), or discontinuation of psychotropic drugs for less than 5 half-lives prior to randomization (except for stable doses of sleep aids received within 4 weeks prior to randomization, including benzodiazepines (limited to estazolam, alprazolam, and oxazepam) and non-benzodiazepines);\n17. Use of monoamine oxidase inhibitors such as phenelzine, isocarboxazid, tranylcypromine, etc., and linezolid, methylene blue, etc., within 2 weeks prior to randomization;\n18. Second or third-degree atrioventricular block, long QT syndrome, or QTcF \\> 450 ms (male)\u002F460 ms (female) on 12-lead ECG at screening;\n19. Discontinuation of drugs that prolong the QT interval (such as levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, and haloperidol, etc.) or drugs that may cause QT interval prolongation and induce torsade de pointes (TdP) for less than 5 half-lives at randomization;\n20. ALT or AST above 2 times the upper limit of normal; creatinine above 1.5 times the upper limit of normal; 2 or more abnormal indicators in thyroid function tests (TSH, FT3, FT4, TT3, or TT4 below 0.9 times the lower limit of normal or above 1.1 times the upper limit of normal) at screening;\n21. Positive for Treponema pallidum antibody and HIV antibody at screening;\n22. Substance abuse (including alcohol, drugs, and other psychoactive substances) within 3 months prior to screening;\n23. Female subjects who are breastfeeding or have a positive pregnancy test at screening or during the trial;\n24. Participation in any interventional clinical trial and use of investigational drugs or medical devices within 3 months prior to screening, or currently participating in other clinical trials;\n25. Other factors deemed by the investigator as unsuitable for participation in the trial.",{"count":181,"type":21},400,[61],"This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase II clinical trial aimed to determine the optimal dose of LV232 capsules for treating MDD, evaluate preliminary efficacy and safety, and provide a basis for Phase III trial design and dosing regimen determination.",[30],"2026-05-18",{"date":187,"type":40},"2026-05-20",{"date":189,"type":40},"2025-04-03",{"date":191,"type":21},"2026-12-20",{"name":193,"class":194},"Vigonvita Life Sciences","INDUSTRY",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100540633","phase-2-cancer-related-major-depression-treated-with-a-single-dose-of-psilocybin-100540633","NCT06319378","Cancer Related Major Depression Treated With a Single Dose of Psilocybin","CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial","CAPSI","Inclusion Criteria\n\n* signed informed consent via minavårdkontakter.se\n* Are 20 to 80 (inclusive) years old at the time of signed informed consent\n* Are able to read, speak, and understand Swedish\n* Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations\n* Are able to swallow capsules\n* Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of exposure to the Investigational Product, from Screening through the Day 8.\n* A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)\n* ≥1 month after cancer diagnosis and ≥ 12 months of life expectancy at time of inclusion\n* physical functioning performance status 0-2 (World Health Organisation\u002FEastern Cooperative Oncology Group (WHO\u002FECOG))\n* Meet ICD-10 criteria for a diagnosis of major depressive disorder and are currently experiencing a major depressive episode of at least a 30-day duration at the time of the Screening less than 1 year at time of Screening\n* Have moderate-severe depression symptoms at Screening, as defined by a Screening PHQ-9 total score ≥ 10.\n* Are willing to abstain from other psychotherapeutic or antidepressant treatments during the study period (180 days; wash out time 5 half-lives). Note, if antidepressant treatment becomes needed as determined by the study physician this will be supported by the study personnel.\n* Have an identified support person.\n* Agree to be driven\u002Faccompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing\n\nExclusion Criteria\n\n* Individuals not eligible to be randomized in this protocol are those who meet any of the following criteria:\n* Last contact with health care due to cancer monitoring or treatment \\>1 year ago.\n* Women who are pregnant, as indicated by a positive urine pregnancy test at Screening or Baseline. Women who intend to become pregnant during the study or who are currently nursing.\n* Unwilling or unable to discontinue formal psychotherapy\n* Ongoing antidepressant drug treatment. No interruption of ongoing antidepressant treatment will be done on the initiation of the study personnel. Patients will be encouraged to discuss any interruption with their responsible clinical physician.\n* Have previously during the current episode received the following non-medication treatments: deep brain stimulation (DBS); vagus nerve stimulation (VNS)\n* Currently receiving electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)\n* Unable or unwilling to discontinue any current medications that are known uridine diphosphate (UDP) or glucuronosyltransferase (UGT) enzyme modulators (eg valproate) Note: Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug plus one week at the time of Baseline. See Appendix A for a full list of prohibited medications.\n* Report psychedelic substances use ever\n\n  o Note: Psychedelic substances include psilocybin, Lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 3,4-methylenedioxy- methamphetamine (MDMA) or other psychedelics.\n* Cancer at time of inclusion involving the Central Nervous System (CNS) (as determined by a clinical examination or Magnetic Resonance Imaging (MRI))\n* Cancer treatment\u002Ffollow up regime determined to be incompatible with the CAPSI protocol (eg due to time lines, interaction between cancer treatment and psilocybin 25 mg or 1 mg exposure).\n* Have any of the following cardiovascular conditions:\n\n  * congenital long QT syndrome (prior diagnosis),\n  * any of the following if disabling physical exercise similar to walking two stairs without pause: coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure\n  * a clinically significant Screening Electro Cardio-Graphy (ECG) abnormality (e.g., atrial fibrillation);\n  * artificial heart valve; or\n  * any other significant current or history of cardiovascular condition, based on the clinical judgment of study physician, that would make a participant unsuitable for the study\n* At Screening or Baseline have elevated blood pressure as defined as:\n\n  a. Screening blood pressure Systolic Blood Pressure \\>150 mmHg or Diastolic Blood Pressure \\> 95 mmHg on three separate readings; or\n\n  o Baseline blood pressure SBP \\>160 mmHg or DBP \\> 100 mmHg on three separate readings\n* Have a history of stroke or Transient Ischemic Attack (TIA)\n* Have moderate to severe hepatic impairment, as indexed by a Child-Pugh score ≥ 7\n* Have uncontrolled epilepsy\n* Have insulin-dependent diabetes\n* Note: Participants who are taking oral hypoglycemic agent and have a history of hypoglycemia requiring medical intervention will be excluded\n* Are unable or unwilling to adhere to the following medication requirements:\n* Agree to suspend sildenafil (Viagra®), tadalafil, or similar medications at least 72 hours prior to dosing\n* Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC). Exceptions are made for prescribed Benzodiazepines (stable dose for sleep or anxiety).\n\n  o Note: Benzodiazepine medications for sleep and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications Note: Participants using cannabis, including legal cannabis, for any purposes will be excluded Note: Participants who are taking prescription maintenance methadone or buprenorphine naloxone will be excluded Note: Prescription opiates must have been stopped at least 5x the elimination half- life of the specific drug at the time of inclusion, as confirmed with a negative urine drug screen.\n* Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period\n* Meet International Classification of Diseases version 10 (ICD-10) criteria for schizophrenia spectrum or other psychotic disorders, including MDD with psychotic features (except substance\u002Fmedication-induced or due to another medical condition), or Bipolar I Disorder, Bipolar II Disorder.\n\nNote: Participants with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders will be excluded\n\n* Meet ICD-10 criteria for antisocial personality disorder\n* Meet ICD-10 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine) Note: Participants with a diagnosis of alcohol or drug use disorder within the past 12 months will be excluded\n* Have the presence of any psychiatric condition or symptom judged by the PI (or designee) to be a more significant clinical problem than MDD for the participant.\n* Have a first-degree relative with schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition).\n* Have a psychiatric condition judged to be incompatible with establishment of rapport with the Facilitators or safe exposure to psilocybin\n* Report the following suicidal ideation or suicidal thoughts defined as\n\n  * Have a score of ≥ 5 on Item 10 (suicidal thoughts) on MADRS at Screening or Baseline; or\n  * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior at any time prior to randomization\n  * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior\n* Have any physical or psychological symptom, medication or other relevant finding at Screening or Baseline, based on the clinical judgment of clinical\u002Fmedical study personnel, that would make a participant unsuitable for the study.\n* Have an allergy or intolerance to any of the materials contained in either drug product\n* Have Hepatitis B, C or HIV (HIV only allowed if on treatment and non-detectable virus\n* concentrations)\n* Have one or more clinically relevant pathological blood test results (as determined by a study physician; with the exception of CRP).","20 Years","80 Years",{"count":206,"type":21},100,[61],"The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:\n\nThe primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)\n\n≥10), \\>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).",[30],[211],"malignant neoplasm","2026-04-07",{"date":214,"type":40},"2026-04-13",{"date":216,"type":40},"2024-04-19",{"date":218,"type":21},"2026-12",{"name":220,"class":47},"Section for Affective Disorders; Northern Stockholm Psychiatry",4,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":15,"sex":228,"minAge":57,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":232,"phases":4,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":114},"100526102","stress-inflammation-and-neuroimaging-in-major-depressive-disorder-as-compared-to-premenstrual-dysphoric-disorder-100526102","NCT06130371","Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder","Inclusion Criteria:\n\n* Women,\n* age between 18 and 40 years (no menopausal women),\n* regular menstrual cycles (25-31 days),\n* normal body mass index (18-35 kg\u002Fm2),\n* German language fluency\n\nExclusion Criteria:\n\n* any neurological or mental disease (only for healthy participants)\n* hormonal, metabolic or chronical diseases\n* pregnancy\n* women who gave birth or were breastfeeding within the last year\n* women with any kind of steroid hormonal treatment\n* oral contraceptive treatment in the last three months\n* psychotropic treatment, only if regular\n* engagement in competitive sports\n* shift work","FEMALE","40 Years",{"count":231,"type":21},75,"OBSERVATIONAL","Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women.\n\nStress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity.\n\nThere are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study.",[30,235],"PMDD",[30,235,237,238,239,240,241],"Stress","Inflammation","Cytokines","fMRI","MIST","2026-03-31",{"date":212,"type":40},{"date":245,"type":40},"2024-01-04",{"date":247,"type":21},"2026-07",{"name":249,"class":47},"University Hospital Tuebingen",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":114},"100626754","nutrimood-inflammation-and-depressive-comorbidity-in-obesity-modulation-by-omega-3-polyunsaturated-fatty-acids-status-100626754","NCT07439744","NUTRIMOOD-Inflammation and Depressive Comorbidity in Obesity: Modulation by Omega-3 Polyunsaturated Fatty Acids Status","Effects of 12-week n-3 PUFA Treatment (EPA) on Depressive Symptoms in Overweight\u002FObese Depressed Subjects With Low n-3 PUFA Status: Relationship With Systemic Inflammation","Inclusion Criteria:\n\n* Major depressive disorder.\n* Antidepressant drug-free.\n\nExclusion Criteria:\n\n* Schizophrenia\n* Mania\n* Anxiety disorders (except for social phobia and generalized anxiety that are often comorbid with MDD)\n* Obsessive-compulsive disorder\n* Post-traumatic stress disorder\n* Alcohol or drug abuse\u002Fdependence (except for nicotine)\n* Active suicidal ideation\n* Serious medical\u002Fneurological conditions, especially requiring corticosteroid\u002Fnon-steroidal anti-inflammatory or immunosuppressive therapies or chronic thyroid hormone replacement","54 Years",{"count":259,"type":21},50,[24],"A 12-week, randomized, placebo-controlled trial testing the efficacy of n-3 PUFA treatment (EPA, 2 g\u002Fday) in alleviating depressive symptoms in a subgroup of obese subjects with comorbid depression and low n-3 PUFA status (n-3 index \\\u003C 8%) (81), from the Taiwanese cohort. Associations with PLA2\u002FCOX2 genotypes, lifestyle, nutritional profiles and gut microbiota will also be determined.",[263,30],"Obese Adults","2026-02-23",{"date":266,"type":40},"2026-02-27",{"date":268,"type":40},"2025-03-01",{"date":270,"type":21},"2027-12",{"name":272,"class":273},"National Science and Technology Council, Taiwan","OTHER_GOV",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":144,"enrollmentInfo":281,"targetDuration":4,"studyType":232,"phases":4,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":114},"100625454","dynamic-network-response-to-tms-treatment-100625454","NCT07422844","Dynamic Network Response to TMS Treatment","Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression","Inclusion Criteria:\n\n* Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation.\n* Men and women will be included in a balanced ratio.\n* German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.\n\nExclusion Criteria:\n\n* Patients younger than 18 or older than 70 will be excluded\n* Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded.\n* Further exclusion criteria for participation are acute or chronic neurological diseases.\n* Patients who are pregnant will not be included in the study.\n* As we use app-based questionnaires, we cannot include participants without internet-enabled devices in the study.",{"count":206,"type":21},"This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment.\n\nAdditionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment.\n\nPatients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.",[30],[285,286,287],"TMS","Brain Networks","Symptom Networks","2026-02-13",{"date":290,"type":40},"2026-02-20",{"date":292,"type":40},"2025-11-24",{"date":294,"type":21},"2031-12-31",{"name":296,"class":47},"Goethe University",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":48},"100613697","at-home-tdcs-as-maintenance-therapy-100613697","NCT07269964","At-Home tDCS as Maintenance Therapy","At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study","MaintenanceDC","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode).\n* Clear indication for maintenance therapy after successful acute treatment (esketamine, rTMS, or ECT) with remission\u002Fimprovement of symptoms.\n* Capacity to provide informed consent, confirmed in a physician-led consent discussion.\n\nExclusion Criteria:\n\n* Currently in the acute treatment phase of an affective disorder and non-response to previous treatments.\n* Currently clinically relevant Axis II disorders.\n* Suicidal risk, including suicidal ideation.\n* Contraindications for tDCS: e.g., skin disease at electrode sites, cochlear implants.\n* Neurological, somatic, or psychiatric comorbidities that could compromise validity or safety.",{"count":306,"type":21},30,[24],"The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment.\n\nParticipant population:\n\nAdults (18+) with depressive disorder who had already improved\u002Fstabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy).\n\nMain questions:\n\nFeasibility: Do participants reliably complete the home program and stay in the study?\n\nPreliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)?\n\nParticipants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up\u002Fdown for comfort.\n\nDuring treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks.\n\nWhere:\n\nDepartment and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich\n\nSafety \\& data privacy:\n\nThe device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.",[30,310,98],"Severe Depression",[312,128,313,314,315],"Non Invasive Brain Stimulation (NIBS)","at-home treatment","tdcs at home","transcranial direct current stimulation","2025-11-25",{"date":318,"type":40},"2025-12-08",{"date":320,"type":40},"2024-10-01",{"date":322,"type":21},"2026-11-29",{"name":324,"class":47},"Technical University of Munich",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":333,"maxAge":92,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":114},"100526241","phase-2-psilocybin-rtms-for-treatment-resistant-depression-100526241","NCT06132178","Psilocybin rTMS for Treatment Resistant Depression","Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder","PSILOBSD","Inclusion Criteria:\n\n1. Adults, ages 22-65.\n2. English language comprehension suitable to understand experimenter instructions and to communicate to study personnel\u002Fstaff reasonably easily.\n3. Current major depressive episode (without psychotic features), either as part of recurrent major depressive disorder (MDD) or single episode MDD with current episode present for at least the past 3 months (as determined by the Structured Clinical Interview for DSM-5; SCID-5).\n4. Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or greater at baseline assessment (at least moderate severity).\n5. 1\\. Treatment-resistant MDD, defined as either: a) failure to respond to an adequate dose and duration of two or more pharmacological treatments, with at least one failed medication trial occurring in the current major depressive episode; or b) failure to respond to an adequate dose and duration of 2 or more pharmacological treatments of different pharmacological classes in one or more past major depressive episodes. Adequate treatment dose and duration will be determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). Augmentation, where an add-on medication is used, will be counted as a second treatment, provided it is approved as an adjunctive treatment of MDD in the country where prescribed.\n6. Willingness and ability to attend daily, full-day visits to the research site for a period of \\~2 weeks and to participate in all study procedures (clinical assessments, treatments, and neurobiological assessments).\n7. If currently taking an antidepressant medication (an SSRI, SNRI, or atypical antidepressant), antipsychotic, and\u002For other augmenting medication (e.g., lithium), willingness to discontinue medication(s) over a 2-8 week period with the assistance of study staff and maintain at least a 2-5 week period (5-week period for fluoxetine) off of medications prior to the baseline visit AND willingness to remain off medications for a period of 1 month following the end of the treatment course (approximately 6-8 weeks after the baseline visit).\n\nExclusion Criteria:\n\n1. Prior history or current diagnosis of a psychotic disorder (including MDD with psychotic features), bipolar disorder, or personality disorder (based on medical history, clinician judgement, SCID-5 and\u002For SCID for Personality Disorders).\n2. Current diagnosis of posttraumatic stress disorder, acute stress disorder, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, or alcohol or substance-use disorder.\n3. Having met criteria for an alcohol or substance-use disorder within the past year.\n4. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current major depressive episode.\n5. Any prior rTMS treatment (10Hz, 5Hz, 1Hz, or conventional intermittent theta burst).\n6. Current participation in an evidence-based psychotherapy for major depression (e.g., cognitive behavioral therapy, behavioral activation). Ongoing supportive psychotherapy is allowable if maintained at the same frequency throughout the duration of the short-term follow-up clinical endpoint (1 month after treatment cessation) of the study and if no recent change in therapy type or frequency for 1 month prior to enrollment.\n7. Exhibiting significant suicide risk within the past 12 months, at screening, or at baseline, as evidenced by: a) suicidal ideation with some intent to act but no specific plan (item #4 from the Columbia Suicide Severity Rating Scale57; C-SSRS); b) suicidal ideation with intent to act and a specific plan (item #5 from the C-SSRS); c) suicide attempt or non-suicidal self-injury requiring medical attention in the past 12 months; or d) self-report of significant suicidal ideation with intent or significant non-suicidal self-injury during screening or baseline clinical interview.\n8. Major depressive episode that is secondary to a medication or a general medical condition, as judged by investigators.\n9. Any other factors, such as major medical conditions, unstable housing or threatening life circumstances, erratic behavior, etc. that are judged by the investigators to be a significant barrier to participation in the study protocol and\u002For to establishing therapeutic rapport necessary for safe administration of psilocybin.\n10. Prior past-year ingestion of a serotonergic psychedelic, e.g., psilocybin, LSD, mescaline, dimethyltryptamine, etc. or more than 5 lifetime ingestions of a serotonergic psychedelic on separate occasions.\n11. Participant unwillingness to not ingest or use additional serotonergic psychedelics outside the context of study procedures for the duration of the study follow-up period (12 months).\n12. Ferrous metal, metallic implants, or implanted medical devices that would preclude administration of rTMS and\u002For participation in MRI procedures, including but not limited to: cochlear implants, implanted brain stimulators, aneurysm clips.\n13. Past history of seizures or epilepsy (rTMS risk).\n14. Neurological disorder, including epilepsy, stroke, or history of brain surgery.\n15. Past penetrating brain injury or any head injury resulting in a loss of consciousness for 30 minutes or more or post-concussive symptoms for more than seven days following a head injury.\n16. Head injury in the past two months, regardless of severity.\n17. Currently pregnant and\u002For nursing or about to become pregnant. A positive urine pregnancy test at screening and\u002For baseline will lead to participant exclusion from the study.\n18. Engagement in sexual intercourse which could result in pregnancy without use of a highly effective contraceptive method throughout participation in the study and for at least three months after COMP360 (psilocybin) administration.\n19. Severe claustrophobia (prohibiting MRI acquisition).\n20. Uncontrolled hypertension (resting blood pressure \\> 140\u002F90 mm hg).\n21. Uncontrolled thyroid disease as indicated by unstable thyroid hormone dosage \\\u003C 3 months prior to screening, or abnormal and clinically significant thyroxine (FT4) levels (a free FT4 measurement will be conducted for all participants with an out-of-range thyroid-stimulating hormone \\[TSH\\] value irrespective of thyroid history).\n22. Lifetime history of cardiomyopathy, stroke, heart disease, heart attack, tachycardia, elongated QT-interval corrected by Friderichia (\\> 450ms for men and \\> 470ms for women); clinically significant cardiac arrhythmia within 1 year of study entry; and\u002For abnormal electrocardiogram on study entry.\n23. Type I diabetes mellitus or uncontrolled Type II diabetes mellitus (defined by hemoglobin A1c \\> 8% at screening) or a history of diabetic ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness (\\\u003C 3 months prior to signing of consent form).\n24. Positive urine drug screening for drugs of abuse at screening and\u002For baseline will trigger a review with participant and assessment for eligibility based on pattern of use and willingness to abstain in conjunction with medical monitor and investigative team.\n25. Clinically-significant results from physical examination, blood test, urine test, vital signs, or ECG at screening and\u002For baseline.\n26. Current enrollment in another interventional study or participation within such a study within 6 months of screening.\n27. Self-reported hypersensitivity to psilocybin or another serotonergic psychedelic.","22 Years",{"count":206,"type":21},[61],"The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.",[338,30,27,339,31],"Treatment Resistant Depression","Recurrent Depression","2025-11-20",{"date":342,"type":40},"2025-11-26",{"date":344,"type":40},"2025-01-10",{"date":346,"type":21},"2030-12-31",{"name":348,"class":47},"University of Texas at Austin",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":15,"sex":16,"minAge":203,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":371,"leadSponsor":373,"locationsCount":114},"100569778","phase-3-efficacy-of-statins-among-major-depressive-disorder-100569778","NCT06698666","Efficacy of Statins Among Major Depressive Disorder","The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.","Inclusion Criteria:\n\n* aged between 20 and 45 years;\n* diagnosis of current MDD, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I\u002FP);\n* The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;\n* the ability to give informed consent and to comply with standard procedures;\n* Males and females; and\n* Stable pharmacological treatment for at least 2 weeks prior to enrolment (changes to medication dose or frequency of therapy excepted) if currently being treated.\n\nExclusion Criteria:\n\n* lifetime or current SCID-I\u002FP diagnosis of a psychotic disorder;\n* lifetime SCID-I\u002FP diagnosis of bipolar I or II disorder or alcohol dependence;\n* acute or unstable systemic medical disorder;\n* inability to comply with the requirements of informed consent or the study protocol;\n* history of intolerance or allergy to study medications;\n* Current pregnancy or breast feeding;\n* Current regular use of statins, corticosteroids, or any other immunomodulatory agents; and\n* Females on Contraception.","45 Years",{"count":358,"type":21},145,[360],"PHASE3","The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat MDD in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are:\n\nDoes Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants with Major Depression Disorder ( MDD )? What medical problems do participants have when taking drug ABC?\n\nParticipants will:\n\nTake Rosuvastatin 10 mg every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Report any side effects for Rosuvastatin 10 mg and reassess the severity of depression using The Montgomery Asberg Depression Rating Scale (MADRS)",[27,30],[364,365,366],"Rosuvastatin","Major depressive disorder","MADRS scale","2025-08-14",{"date":369,"type":40},"2025-08-17",{"date":42,"type":40},{"date":372,"type":21},"2025-12-31",{"name":374,"class":47},"Ain Shams University",{"id":376,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":25,"conditions":379,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":385,"locationsCount":48},"100472876",{"count":20,"type":21},[24],[27,28,29,30,31,32,33,34,35],"2025-07-08",{"date":382,"type":40},"2025-07-11",{"date":42,"type":40},{"date":44,"type":21},{"name":46,"class":47}]