[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-depression-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-depression-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,73,99,126,153,181],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100567729","phase-1-study-of-the-safety-tolerability-electrophysiological-effects-and-efficacy-of-dmt-in-humans-100567729",false,"NCT06671977","Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans","Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans","DMT-Bolus","Some Common Inclusion Criteria:\n\n1. Males and females\n2. Age 21 to 65 years\n3. Body mass index between 18-35 kg\u002Fm2\n4. Willing to refrain from taking any medications not approved by the study physician\n5. Willing to refrain from using street drugs and alcohol\n6. Negative urine drug screen\n7. Willing and able to abstain from smoking throughout each test session\n8. Women who are of child-bearing potential (WOCBP) and sexually active must be willing to practice an effective means of birth control\n9. Willing not to drive to and from the testing session\n\nSome Inclusion Criteria for Subjects with MDD:\n\n1. Diagnosed with Major Depressive Disorder (MDD)\n2. Unsatisfactory response to antidepressants\n3. Engaged in treatment for depression with a clinician and willing to continue treatment for the duration of the study\n4. Not engaged in treatment\n5. Consent to allow the research team to communicate with mental health provider.\n6. Only subjects who get support for participation in the trial from their mental health clinician will be eligible to be enrolled in the study\n\nSome Common Exclusion Criteria:\n\n1. Medications that might significantly interfere with the effects of the study medications\n2. Cognitive dysfunction that could interfere with study participation\n3. Alcohol or substance use disorder\n4. Any lifetime history of hallucinogen use disorder\n5. Regular use or misuse of hallucinogens\n6. History of intolerance to perceptual altering drugs\n7. Significant blood pressure problems\n8. Pregnancy or currently breast feeding (lactation)\n9. Any unstable medical conditions\n10. Significant cardiovascular disease\n11. Significantly abnormal laboratory test results\n12. History of serotonin syndrome\n\nSome Exclusion criteria for MDD subjects:\n\n1. Current primary psychiatric disorder other than MDD\n2. Medically significant condition rendering unsuitability for the study\n\nSome Exclusion criteria for healthy controls:\n\n1. No current DSM-V psychiatric disorder, excluding nicotine and caffeine use disorder\n2. No family history of serious mental illness (e.g., schizophrenia, bipolar disorder)\n\nSome Inclusion criteria for healthy controls:\n\n1. No current DSM-5 psychiatric disorder, excluding nicotine and caffeine use disorder\n2. No lifetime use of psychiatric medication \\>3 months (proxy for psychiatric disorders)",true,"ALL","21 Years","65 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.",[29,30],"Major Depression Disorder","Depression","RECRUITING","2026-06-12",{"date":34,"type":35},"2026-06-16","ACTUAL",{"date":37,"type":35},"2025-03-14",{"date":39,"type":23},"2027-12-01",{"name":41,"class":42},"Deepak C. D'Souza","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100632222","home-tdcs-for-the-treatment-of-major-depression-100632222","NCT07510880","Home tDCS for the Treatment of Major Depression.","Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial","Inclusion Criteria:\n\n* Spanish or Catalan speakers of both sexes between the ages of 18 and 65.\n* Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).\n* Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.\n* Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.\n* Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion.\n\nExclusion Criteria:\n\n* Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).\n* Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).\n* Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers. Brain stimulation in the last 6 months. Clinical or family history of epilepsy.\n* Patients with dermatological problems, such as an allergic skin reaction at the electrode site.\n* High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016).\n* Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine).\n* Changes in pharmacological or non-pharmacological treatment (such as structured psychotherapy) during the study or in the 3 months prior to starting the trial.\n* Pregnancy.","18 Years",{"count":53,"type":23},198,[55],"NA","The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol.\n\nThe change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.",[29],[59,60,61],"Major Depression","Electric Stimulation Therapy","Transcranial Direct Current Stimulation","2026-04-27",{"date":64,"type":35},"2026-05-01",{"date":66,"type":35},"2026-04-14",{"date":68,"type":23},"2027-12-31",{"name":70,"class":71},"Ionclinics & Deionic SL","INDUSTRY",3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100634718","transcranial-photobiomodulation-tpbm-for-somatic-symptoms-in-treatment-resistant-depression-100634718","NCT07543328","Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression","The Clinical Efficacy of Prefrontal Transcranial Photobiomodulation (tPBM) in Patients With Treatment-Resistant Major Depressive Disorder: A Subgroup Analysis Focusing on Somatic Symptoms","Inclusion Criteria:\n\nMust have a current diagnosis of Major Depressive Disorder (MDD).\n\nThe clinical severity must be evaluated by a psychiatrist as moderate or above, defined as a Clinical Global Impression-Severity (CGI-S) score \\> 4 and a 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 18.\n\nMust be currently receiving stable antidepressant treatment for at least four weeks but showing inadequate response (treatment-resistant). This study will be conducted as an add-on therapy.\n\nMust have full behavioral capacity, normal intellectual functioning, and the ability to comprehend and sign the informed consent form.\n\nExclusion Criteria:\n\nIndividuals diagnosed with Bipolar Disorder or Schizophrenia.\n\nIndividuals with current or recent Substance Use Disorder.\n\nHistory of organic brain lesions (e.g., neurodegenerative diseases, epilepsy, stroke) or any medical conditions affecting central nervous system function.\n\nIndividuals with abnormal intellectual functioning based on clinical judgment (e.g., suspected intellectual disability, severe learning difficulties).\n\nIndividuals who are currently pregnant (due to limited evidence regarding the safety of tPBM during pregnancy).\n\nAny other condition that, in the investigator's judgment, would render the participant unable to cooperate, unsuitable for the study, or unwilling to sign the informed consent.",{"count":81,"type":23},40,[55],"The primary objective of this study is to evaluate the clinical efficacy of moderate-dose transcranial photobiomodulation (t-PBM) at different frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression (TRD). It further aims to explore the differential efficacy across various symptom subtypes, with a particular focus on the somatic symptom-dominant subtype. Additionally, this study will collect paired-pulse neurophysiological parameters (e.g., the ratio of cortical inhibition to excitation) to preliminarily explore the neural mechanisms underlying the modulation of cortical excitability by t-PBM intervention, and to analyze their correlation with the magnitude of clinical symptom improvement.\n\nThe specific aims of this study are as follows:\n\nTo evaluate the differential efficacy of t-PBM at varying frequencies (10 Hz vs. 40 Hz) in improving clinical depressive symptoms (as measured by scales such as HAM-D and MADRS).\n\nTo investigate the therapeutic response to t-PBM in patients with the somatic symptom-dominant depression subtype, analyzing its potential suitability for targeting specific symptoms.\n\nTo explore the changes in paired-pulse TMS parameters (e.g., SICI, ICF, and LICI) before and after t-PBM treatment, gaining preliminary insights into the potential association between its cortical modulatory effects and clinical outcomes.",[85,29],"Treatment-resistant Depression (TRD)",[87,29,88],"Photobiomodulation","tPBM","2026-04-24",{"date":91,"type":35},"2026-04-30",{"date":93,"type":35},"2026-01-06",{"date":95,"type":23},"2027-03-31",{"name":97,"class":98},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":18,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":43},"100619614","digital-interventions-for-relapse-prevention-in-adolescence-100619614","NCT07346911","Digital Interventions for Relapse Prevention in Adolescence","DigiTIFF","Inclusion Criteria:\n\n* Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score \\> 65 and current t-score =\\\u003C65.\n* Native or fluent Scandinavian language skills.\n* Willingness to take part even when allocated to the non-preferred arm of the trial.\n\nExclusion Criteria:\n\n* Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =\\\u003C65 on RCADS-47.\n* Recent completion of one of the interventions in the two interventional arms.\n* no available smartphone.","16 Years","19 Years",{"count":109,"type":23},495,[55],"Some adolescents experience periods of anxiety and\u002For depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.\n\nThe study includes adolescents aged 16-19 who have previously experienced episodes of depression and\u002For anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.\n\nWe will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.",[29,113],"ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)",[115],"Transdiagnostic interventions","NOT_YET_RECRUITING","2026-03-12",{"date":119,"type":35},"2026-03-13",{"date":121,"type":23},"2026-04-07",{"date":123,"type":23},"2027-06-01",{"name":125,"class":42},"University of Oslo",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":24,"phases":135,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":43},"100601490","neuromodulation-and-attention-deficits-in-mdd-100601490","NCT07111169","Neuromodulation and Attention Deficits in MDD","Selective Attention Deficits and Neuromodulation in Major Depressive Disorder: Using EEG and MRI-guided iTBS Study","Inclusion Criteria:\n\n* 18-55 years\n* Right-handed\n* Normal or corrected normal visual acuity\n* MDD: meet the proposed DSM-5 MDD criteria, unmedicated or stable medicated within the last one month. Healthy subjects without any past or present psychiatric or neurological disorders.\n\nExclusion Criteria:\n\n* Diagnosis of other severe mental disorders, such as schizophrenia, bipolar disorder, neurodevelopmental disorder, etc.\n* high suicidal risk\n* Unnormal intellectual functioning, auditory impairments,\n* Have received neuromodulation, such as Modified Electroconvulsive Therapy (MECT), or any psychotherapy within the past 6 months.\n* Only for the active-iTBS group: have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).","55 Years",{"count":22,"type":23},[55],"Multimodal study (Behavior, TMS, EEG) combining a sham-controlled intermittent theta burst stimulation (iTBS) intervention with an additional-singleton task and EEG to evaluate whether left dorsolateral prefrontal cortex (DLPFC) stimulation enhances cognitive control and modulates maladaptive attention processes in MDD and whether the effects are influenced by neuronavigated versus manual (Beam F3 method) localization of the stimulation site.",[29,138,139],"Cognitive Deficits","Selective Attention",[141,142,143],"iTBS","EEG","MDD","2025-07-31",{"date":146,"type":35},"2025-08-08",{"date":148,"type":35},"2024-01-01",{"date":150,"type":23},"2028-12-30",{"name":152,"class":42},"University of Electronic Science and Technology of China",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":20,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":180},"100595970","molecular-signatures-of-tms-response-in-treatment-resistant-depression-100595970","NCT07039370","Molecular Signatures of TMS Response in Treatment-Resistant Depression","The Relationship Between Plasma Metabolomics and Proteomics Profiling and Response to Transcranial Magnetic Stimulation Therapy in Treatment-Resistant Depression","PROMET_TMS","Inclusion Criteria:\n\n* Diagnosis of Major Depressive Disorder (MDD) according to DSM-5-TR criteria.\n* Inadequate clinical response to at least two different antidepressants and\u002For anti-obsessive agents administered at therapeutic doses and durations.\n* Clinical symptoms not better explained by metabolic or organic medical conditions.\n* No epileptic activity detected on routine electroencephalography (EEG) prior to TMS initiation.\n* Routine pre-TMS laboratory tests reveal no abnormalities that may significantly affect treatment response, including:\n* Normal thyroid hormone profile\n* No significant vitamin deficiencies\n* No markedly elevated inflammatory markers\n* No history or current evidence of hearing loss on clinical evaluation; if present, evaluation by an otolaryngologist will be obtained.\n* Age 18 years and older.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Any contraindication to TMS as identified in the standardized pre-TMS risk assessment form.\n* Presence of epileptic focus detected on pre-TMS EEG.\n* History of significant head trauma, loss of consciousness, or intracranial surgery.\n* Presence of metal implants or foreign bodies incompatible with TMS (e.g., aneurysm clips, surgical clamps, metallic fragments).\n* Abnormal thyroid hormone levels in pre-TMS laboratory testing.\n* Significantly elevated inflammation markers (e.g., CRP) in pre-TMS bloodwork.\n* Vitamin deficiencies associated with cognitive impairment (e.g., B12, folate) in pre-TMS labs.\n* Electrolyte imbalances on pre-TMS blood testing.\n* History of psychotic disorder or bipolar I\u002FII disorder.\n* History of substance-induced psychosis or bipolar disorder.\n* Current or past substance use disorder (including alcohol, stimulants, or illicit drugs), unless abstinent from substances (excluding alcohol) for a minimum of 12 months.\n* Voluntary discontinuation of TMS during the treatment course.\n* Any serious adverse event or unexpected clinical condition during treatment that necessitates discontinuation of TMS.",{"count":162,"type":23},55,[55],"Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option for treatment-resistant depression (TRD). This study aims to identify biomarkers that predict TMS treatment response in TRD, provide insights into the neurobiological mechanisms underlying TMS efficacy, and contribute to personalized treatment strategies. By establishing proteomic and metabolomic signatures, this research seeks to enhance clinical decision-making, reduce healthcare costs, and improve patient outcomes in TRD. The findings will align with the precision medicine movement in psychiatry, advancing biomarker-driven therapeutic approaches for treatment-resistant depression.",[29],[167,168,169,170,171],"TMS","Metabolomics","Proteomics","Treatment Resistance","Molecular Signuture","2025-06-17",{"date":174,"type":35},"2025-06-26",{"date":176,"type":35},"2025-06-15",{"date":123,"type":23},{"name":179,"class":98},"Gulhane Training and Research Hospital",2,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":190,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100571824","the-observe-protocol-100571824","NCT06725277","The OBSERVE Protocol","Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Recently started treatment (within 75 days of screening visit) with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. These patients are referred to as treatment-continuing subjects.\n\n   OR\n2. Scheduled to receive standard clinical treatment with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features. These patients are referred to as treatment-initiating subjects.\n\n   In addition, in order to be eligible, an individual must meet all of the following additional criteria:\n3. Adult ages 18 or older\n4. Provision of signed and dated informed consent form prior to any study procedures\n5. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)\n2. Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis\n3. Active or recent (within 12 months) substance use disorder (other than nicotine)",{"count":189,"type":23},450,"60 Months","OBSERVATIONAL","This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches.\n\nThis 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.",[29],"2025-05-02",{"date":196,"type":35},"2025-05-06",{"date":198,"type":35},"2024-01-21",{"date":200,"type":23},"2029-12",{"name":202,"class":42},"Yale University",6]