[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-depressive-disorder-mdd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-depressive-disorder-mdd":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,100,0,25,[9,51,83,114,148,184,212,243,271,297,329,350,371,390,419,444,455,478,501,524,546,571,583,609,641],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053451","phase-2-acp-211-monotherapy-for-major-depressive-disorder-with-inadequate-antidepressant-response-100053451",false,"NCT07284667","ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response","A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment","NORLIGHT","Inclusion Criteria:\n\n* Adults ≥18 and ≤65 years of age\n* Provides written informed consent\n* Clinical diagnosis of MDD\n* History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode\n* Currently treated with an approved antidepressant at a stable dose prior to Screening\n* MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline\n* Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation\n\nExclusion Criteria:\n\n* Current diagnosis of certain personality disorders or persistent depressive disorder\n* Recent substance use disorders, excluding caffeine or nicotine\n* Active suicidal risk or recent suicidal attempt\n* History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features\n* Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD\n* History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)\n* Documented non-response to ADT, including ketamine or esketamine\n* Allergy or sensitivity to ketamine or esketamine\n* Significant cardiovascular disease\n* Positive history of hepatitis B, hepatitis C, or HIV infection\n* Unstable diabetes or uncontrolled medical conditions\n* Positive urine drug test for an illicit drug or cannabis\n* Received neuromodulation therapies (ECT,TMS, VNS, DBS) in the current depressive episode\n* Recent initiation or change in psychotherapy Additional inclusion\u002Fexclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.","ALL","18 Years","65 Years",{"count":22,"type":23},153,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).\n\nThe main questions the study aims to answer are:\n\n* Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?\n* What adverse events do participants have when taking ACP-211?",[29,30],"Major Depressive Disorder (MDD)","Depressive Disorder, Treatment-Resistant",[29,30,32,33,34,35,36,37],"Antidepressive Agents","Randomized Controlled Trial","Double-Blind Method","Clinical Trial, Phase II","Psychiatric Status Rating Scales","Ketamine","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2025-11-14",{"date":46,"type":23},"2027-09",{"name":48,"class":49},"ACADIA Pharmaceuticals Inc.","INDUSTRY",23,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100054051","imaging--vs-scalp-targeted-accelerated-tms-for-depression-the-number-needed-to-scan-trial-100054051","NCT07043738","Imaging- vs. Scalp-Targeted Accelerated TMS for Depression: The Number Needed to Scan Trial","NNS","Inclusion Criteria:\n\n* Age 22-80\n* English proficiency sufficient for informed consent, questionnaires\u002Ftasks, and treatment\n* Primary diagnosis of major depressive disorder per DSM-V criteria (Quick Structured Clinical Interview for DSM-5)\n\n  * \\>20 on Beck Depression Inventory (BDI)\n  * \\>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)\n  * Moderate to severe level of treatment resistance (Maudsley Staging Method)\n* Stable antidepressant medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the 1-month post-treatment visit.\n* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n* Agreement to lifestyle considerations\n\n  * Abstain from becoming pregnant from screening to one-month after treatment (the MRI visit)\n  * Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment\n  * Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and TMS session","22 Years","80 Years",{"count":61,"type":23},160,[63],"NA","Transcranial magnetic stimulation(TMS) is a non-invasive form of brain stimulation that is cleared by the United States Food and Drug Administration (FDA) for depression. Conventional TMS involves daily weekday treatments for 6-8 weeks. These treatments are targeted using each person's scalp measurements. With conventional TMS, approximately 50-55% of people show a 50% or more improvement in depressive symptoms (in other words, they \"respond\" to treatment).\n\nStudies are trying to make TMS work better and faster. A new form of TMS called accelerated TMS (aTMS) involves mutliple treatments a day. One specific aTMS protocol involves 10 treatments per day for 5 days. These treatments are targeted using each person's brain scan (magentic resonance imaging, MRI). With this specific aTMS protocol, approximately 70-90% of people show a 50% or more imporvement in depressive symptoms. While these results are exciting, scientists are not sure why this specific aTMS protocol works better than conventional TMS. It could be the dose and schedule of treatment, or it could be the MRI-based targeting. Answering this question is important because MRI-based targeting is expensive and difficult to do in many settings.\n\nThis study aims to determine if MRI-based targeting is better than scalp-based targeting for aTMS for depression. In this study, everyone who enrolls and meets criteria will be randomly assigned to MRI- versus scalp-based aTMS targeting.",[29],[67,68,69,70,71,72,73],"Accelerated Transcranial Magnetic Stimulation","Depression","Major Depressive Disorder","Treatment resistant depression","TMS","Transcranial Magnetic Stimulation","Neuromodulation","NOT_YET_RECRUITING",{"date":41,"type":42},{"date":77,"type":23},"2026-08-03",{"date":79,"type":23},"2032-08",{"name":81,"class":82},"Brigham and Women's Hospital","OTHER",{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":90,"targetDuration":4,"studyType":24,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100053343","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-spt-300-glyphallo-in-participants-with-major-depressive-disorder-with-or-without-anxious-distress-buoy-1-study-100053343","NCT07065240","A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)","A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress","Inclusion Criteria:\n\n* Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.\n* Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.\n* Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.\n* Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.\n* Body mass index (BMI) between 18 to 40 kg\u002Fm2, inclusive.\n* Participant is willing and able to refrain from the use of drugs of abuse.\n\nExclusion Criteria:\n\n* History of, or current presentation consistent with:\n\n  1. any depressive episode with psychotic or catatonic features.\n  2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic\u002Fmixed episode.\n  3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.\n  4. schizophrenia, schizoaffective, or other psychotic disorder.\n  5. obsessive-compulsive disorder.\n  6. any persistent neurocognitive disorder.\n* History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.\n* Psychiatric hospitalization within current depressive episode.\n* Evidence or history of clinically significant diseases which can affect the patients' participation.\n* Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300\u002Fplacebo formulation.\n* Participant has a history of drug or alcohol use disorder.\n* Participants with a positive test for cannabinoids.\n* Clinically significant risk of suicide or harm to self or others.",{"count":91,"type":23},360,[26],"This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.",[29,95],"Major Depressive Disorder With Anxious Distress",[69,97,68,98,99,100,101,102,103,104],"Depressive Disorder","Anxiety","Mood Disorders","BUOY-1 Study","SPT-300","LYT-300","GlyphAllo","Glyph Allopregnanolone","2026-07-09",{"date":41,"type":42},{"date":108,"type":42},"2025-06-19",{"date":110,"type":23},"2027-03",{"name":112,"class":49},"Seaport Therapeutics",61,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":24,"phases":124,"briefSummary":125,"conditions":126,"keywords":131,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"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",{"count":123,"type":23},140,[26],"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.",[127,29,128,129,130],"MDD","Major Depression","Suicidal Ideation","Suicide",[132,133,134,135,136,137,138,139],"DMT","major depressive disorder","N,N-dimethyltryptamine","psychedelic therapy","inhaled DMT","vaporized DMT","suicidality","non invasive",{"date":41,"type":42},{"date":142,"type":23},"2026-08-01",{"date":144,"type":23},"2027-08-01",{"name":146,"class":82},"Universidade Federal do Rio Grande do Norte",5,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":161,"conditions":162,"keywords":167,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100577061","phase-3-a-study-of-a-deuterated-psilocin-analog-cyb003-in-humans-with-major-depressive-disorder-100577061","NCT06793397","A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder","An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder","EMBRACE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.\n* Participant has a body mass index (BMI) of 40 kg\u002Fm2 or less (BMI ≤40 kg\u002Fm2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.\n* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.\n* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded from trial participation:\n\n* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.\n* Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.","85 Years",{"count":158,"type":23},330,[160],"PHASE3","The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.\n\nFor more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https:\u002F\u002Fembrace-mdd-trial.com\u002F",[29,163,164,165,166,68],"Depression in Adults","Depression - Major Depressive Disorder","Depression Disorders","Depression Disorder",[127,168,68,69,169,170,171,172,173],"Psychedelic","CYB003","CYB003-001","CYB003-002","Psilocybin","psilocin-7438","2026-06-29",{"date":176,"type":42},"2026-06-30",{"date":178,"type":42},"2025-12-10",{"date":180,"type":23},"2027-05-08",{"name":182,"class":49},"Cybin IRL Limited",68,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":190,"sex":18,"minAge":19,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":24,"phases":194,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100632017","efficacy-of-bright-light-therapy-on-cognitive-impairment-in-major-depressive-disorder-and-its-neuroimaging-mechanisms-protocol-for-a-randomised-controlled-trial-100632017","NCT07508215","Efficacy of Bright Light Therapy on Cognitive Impairment in Major Depressive Disorder and Its Neuroimaging Mechanisms: Protocol for a Randomised Controlled Trial","The inclusion and exclusion criteria for MDD patients. 1、Inclusion Criteria:\n\n1. MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-Ⅳ), first episode or recurrence, confirmed by an experienced psychiatrist using the Mini International Neuropsychiatric Interview.\n2. Age between 18 and 60 years; and gender no-limited;\n3. The severity of MDD symptoms must be ≥14 scores on the HAMD-17;\n4. With CI currently, defined as a total score of \\\u003C70 on the SC;\n5. A SSRI monotherapy at stable dosages for at least 4 weeks; or medication-free status;\n6. Education level above primary school, able to understand and cooperate in completing the study procedures;\n7. Voluntarily participating in this study and sign the informed consent before enrollment.\n\n2、Exclusion Criteria:\n\n1. Current or past diagnosis of any disorder other than MDD according to DSM-Ⅳ criteria;\n2. The scores on the Young Mania Rating Scale (YMRS) are\\>8;\n3. The participants who have undergone other intervention in addition to SSRIs whinin the past 6 months or now, or who plan to do that in 1 month;\n4. The participants with strong self-blame, self-harm, or suicidal risks (the HAMD-17 suicide item score of ≥3);\n5. The participants with severe physical illnesses, including heart failure, renal failure, severe liver dysfunction, hyperthyroidism, or hypothyroidism; Or a history of severe brain trauma or organic brain pathology (e.g., intracerebral hemorrhage, large-area cerebral infarction, encephalitis, epilepsy), as well as neurological diseases;\n6. The participants with any degree of retinal pathology, including retinal dystrophy, age-related macular degeneration, diabetic retinopathy, cataracts, glaucoma, or other ocular diseases;\n7. The participants with photosensitive conditions, such as systemic lupus erythematosus, porphyria, chronic photodermatitis, solar urticaria, or those currently receiving medications that may increase photosensitivity (e.g., phenothiazines, antimalarials, propranolol, hypericin, stimulants, or chronic treatment with nonsteroidal anti-inflammatory drugs);\n8. Pregnant or lactating women;\n9. The participants with contraindications to MRI, such as the presence of non-MRI-safe metallic implants or claustrophobia;\n10. The participants deem unsuitable for inclusion in this study by the investigator for other reasons.\n\nWithdrawal and Termination Criteria：\n\n1. The participants meet one of the exclusion criteria above after enrollment;\n2. When the participants' treatment regimen need change;\n3. The participants who fail to cooperate or voluntarily withdraw from the study;\n4. Due to severe adverse events, the patients are unable to tolerate phototherapy;\n5. The participants who fail to adhere to the study protocol intervention for three consecutive days or for a cumulative duration exceeding seven days;\n6. Cancellation of the study.\n\nThe inclusion and exclusion criteria for Health controls\n\n1\\. Inclusion criteria\n\n1. Age between 18 and 60 years; and gender no-limited;\n2. Without CI currently, defined as a total score of ≤ 70 on the SC;\n3. Education level above primary school, able to understand and cooperate in completing the study procedures;\n4. Voluntarily participating in this study and sign the informed consent before enrollment.\n\n2.Exclusion criteria\n\n1. Current or past diagnosis of any psychiatric disorders, or history of substance\u002Fdrug abuse or dependence;\n2. Current or past diagnosis of severe somatic diseases, such as heart failure, renal failure, severe liver dysfunction, or hyperthyroidism\u002Fhypothyroidism;\n3. History of severe traumatic brain injury or organic brain lesions;\n4. Pregnant or lactating women;\n5. The participants with contraindications to MRI, such as the presence of non-MRI-safe metallic implants or claustrophobia.\n6. The participants deem unsuitable for inclusion in this study by the investigator for other reasons.",true,"60 Years",{"count":193,"type":23},120,[63],"This study aims to validate the therapeutic efficacy and safety of bright light therapy (BLT) in ameliorating cognitive impairment (CI) in major depressive disorder (MDD), characterize the functional and structural features of the hippocampus (HPC)-dorsolateral prefrontal cortex (dlPFC) neural circuitry in MDD participants with CI and examine the mediating effect of the HPC-dlPFC neural circuit on CI induced by BLT treatment in MDD participants. MDD participants will be required to only receive selective serotonin reuptake inhibitors (SSRIs) as monotherapy for at least four weeks, or medication-free status before enrollment. Eligible participants will be randomly assigned to the experimental group and the control group. The experimental group will receive the intervention of BLT, and the control group will receive the intervention of dim red light (DRL). The intervention will last for four weeks, 6 days per week, with 40 minutes each day between 7 am and 10 am. The MDD participants will be followed once in the end of each week during the 4-week intervention and in the end of the 4th week after intervention. Demographic information will be collected at baseline; cognitive function will be evaluated at baseline, weeks 2, 4, and 8 after intervention beginning; and other symptoms such as depression, anxiety and sleep were assessed at baseline, weeks 1, 2, 3, 4, and 8 after intervention beginning. Moreover, structural and functional MRI scans will be made at baseline and post-intervention. During the intervention, MDD participants will be required to keep a record of daily light exposure duration and complete the daily sleep diary as well.",[29,197,198,199],"Neuroimaging","Bright Light Treatment","Cognitive Impairment",[69,197,201,202,199,33],"Magnetic Response Imaging","Bright Light Therapy","2026-06-28",{"date":176,"type":42},{"date":206,"type":42},"2026-02-08",{"date":208,"type":23},"2028-12-31",{"name":210,"class":82},"Peking University Sixth Hospital",2,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":24,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":240,"locationsCount":242},"100645324","accelerated-itbs-for-ptsd-and-depression-100645324","NCT07682207","Accelerated iTBS for PTSD and Depression","Accelerated Intermittent Theta Burst Stimulation for Depression in Post-Traumatic Stress Disorder: A Single-Arm, Open-Label Feasibility Study","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Current post-traumatic stress disorder (PTSD) and current major depressive disorder (MDD), confirmed by a structured diagnostic interview (e.g., MINI 6.0 using the PTSD and MDD modules).\n* Minimum symptom severity at baseline: HAMD-17 score ≥14 (moderate depression) and\u002For PCL-5 score ≥33 (probable PTSD).\n* On a stable pharmacologic and\u002For psychotherapeutic regimen for at least 4 weeks prior to baseline, and willing to maintain stability during the treatment phase, unless medically necessary.\n* Capacity to provide informed consent and comply with study procedures and visits at St. Joseph's Health Care, London\u002FParkwood Institute.\n* Sufficient English proficiency to complete consent and study assessments.\n\nExclusion Criteria:\n\n* Neurologic or device-related risks, including seizure history, traumatic brain injury with loss of consciousness greater than 5 minutes, major neurologic illness, or metal\u002Felectronic implants contraindicated for transcranial magnetic stimulation.\n* Psychiatric or substance-related risks, including current psychotic disorder, acute mania, diagnosis of Bipolar I or Bipolar II disorder, recent substance use disorder, or imminent suicide risk.\n* Medical or medication-related risks, including unstable severe illness, high-risk medications, hearing impairment, unwillingness to use ear protection, or prior non-response to an adequate course of theta burst stimulation for the current depression\u002FPTSD episode.\n* Enrollment in another interventional trial.\n* Inability to comply with the study schedule.",{"count":220,"type":23},16,[63],"The goal of this pilot clinical trial is to learn if a faster brain stimulation schedule is practical, safe, tolerable, and acceptable. This study looks at accelerated intermittent theta burst stimulation, or accelerated iTBS. This is a non-invasive type of magnetic brain stimulation. This study is for adults with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD).\n\nThe main questions this study aims to answer are:\n\n1. Can participants complete six short brain stimulation sessions per day for five days?\n2. Is this treatment schedule safe and tolerable for participants?\n3. What changes occur in depression symptoms, PTSD symptoms, anxiety, quality of life, and brain activity over time?\n\nParticipants will:\n\n1. Complete health screening and baseline assessments.\n2. Receive six short sessions of magnetic brain stimulation per day for five days.\n3. Have their brain activity measured using an EEG recording.\n4. Return for a post-treatment assessment at Week 2 and follow-up visits at Week 5 and Week 12.",[224,29],"Post Traumatic Stress Disorder PTSD",[226,127,68,227,228,229,230,231,71,232,233],"PTSD","Feasibility study","Accelerated intermittent theta burst stimulation","iTBS","Theta burst stimulation","Transcranial magnetic stimulation","Brain stimulation","EEG","2026-06-26",{"date":236,"type":42},"2026-07-02",{"date":238,"type":23},"2026-07",{"date":46,"type":23},{"name":241,"class":82},"Lawson Research Institute of St. Joseph's",1,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":190,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":252,"phases":4,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":242},"100645203","type-d-personality-and-life-satisfaction-in-bipolar-disorder-type-2-and-major-depressive-disorder-100645203","NCT07679204","Type D Personality and Life Satisfaction in Bipolar Disorder Type 2 and Major Depressive Disorder","Examination of Type D Personality and Factors Associated With Life Satisfaction in Parents of Patients Diagnosed With Bipolar Disorder Type 2 and Major Depressive Disorder","1. For Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Inclusion Criteria:\n   * Diagnosis of BD-II according to DSM-5-TR\n   * Remission period\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Exclusion Criteria:\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Primary psychiatric disorders other than BD-II and not in remission for BD-II\n   * Alcohol\u002Fdrug\u002Fsubstance use\n2. For Major Depressive Disorder (MDD) Group:\n\n   \\*Inclusion Criteria:\n   * Diagnosis of MDD according to DSM-5-TR\n   * Remission period\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Major Depressive Disorder (MDD) Group:\n   * Exclusion Criteria:\n\n     * Hypertension\n     * Diabetes mellitus\n     * Chronic kidney disease\n     * Rheumatoid arthritis\n     * Systemic lupus erythematosus\n     * Cardiac illness\n     * Severe neurological disorders\n     * Immunological or systemic illness\n     * Primary psychiatric disorders other than MDD and not in remission for MDD\n     * Alcohol\u002Fdrug\u002Fsubstance use\n3. For Healthy Control (HC) Group:\n\n   \\*Inclusion Criteria:\n   * No psychiatric diagnosis\n   * No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Control (HC) Group:\n\n   \\*Exclusion Criteria:\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use\n4. For Healthy Father and\u002For Mother of Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Inclusion Criteria:\n   * No psychiatric diagnosis\n   * No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Father and\u002For Mother of Bipolar Disorder Type II (BD-II) Group:\n\n   \\*Exclusion Criteria:\n\n   • Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use\n5. For Healthy Father and\u002For Mother of Major Depressive Disorder (MDD) Group:\n\n   \\*Inclusion Criteria:\n   * No psychiatric diagnosis\n   * No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Father and\u002For Mother of Major Depressive Disorder (MDD) Group:\n\n   \\*Exclusion Criteria:\n\n   • Hypertension\n\n   • Diabetes mellitus\n\n   • Chronic kidney disease\n\n   • Rheumatoid arthritis\n\n   • Systemic lupus erythematosus\n\n   • Cardiac illness\n\n   • Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use\n6. For Healthy Father and\u002For Mother of Healthy Control (HC) Group:\n\n   \\*Inclusion Criteria:\n\n   • No psychiatric diagnosis\n\n   • No systemic or immunological illness\n   * Medication-free for at least one month\n   * Age ≥ 18 years\n   * Provided informed consent\n\n   For Healthy Father and\u002For Mother of Healthy Control (HC) Group:\n\n   \\*Exclusion Criteria:\n   * Hypertension\n   * Diabetes mellitus\n   * Chronic kidney disease\n   * Rheumatoid arthritis\n   * Systemic lupus erythematosus\n   * Cardiac illness\n   * Severe neurological disorders\n   * Immunological or systemic illness\n   * Having psychiatric disorders\n   * Alcohol\u002Fdrug\u002Fsubstance use",{"count":251,"type":23},180,"OBSERVATIONAL","Bipolar Disorder Type II (BD-II) and Major Depressive Disorder (MDD) are common mood disorders associated with substantial psychological distress, impaired functioning, and reduced quality of life. BD-II is characterized by recurrent major depressive episodes and hypomanic episodes, whereas MDD is characterized by one or more major depressive episodes without a history of mania or hypomania. Both disorders have a significant genetic component, and family studies suggest that first-degree relatives may exhibit subclinical affective traits, personality characteristics, and psychosocial vulnerabilities related to these conditions. The aim of this cross-sectional study was to examine Type D personality traits and life satisfaction among patients with BD-II and MDD and parents of patients. The study recruited\u002Fwill recruit 30 patients with BD-II; 30 patients with MDD; 30 healthy control subjects; mothers and\u002For fathers of 30 healthy control subjects, mothers and\u002For fathers of 30 patients with BD-II, and mothers and\u002For fathers of 30 patients with MDD who are in remission and receiving follow-up care at the Psychiatry Outpatient Clinic of Elazığ Fethi Sekin City Hospital, Turkey (By Dilek ÖRÜM -Associate Professor of Psychiatry, dr.dilekulukan@gmail.com). Sociodemographic characteristics, Type D personality traits, general psychiatric symptoms, and life satisfaction assessed\u002Fwill be assessed using validated self-report measures, including the Type D Personality Scale (DS14), the Brief Psychiatric Rating Scale (BPRS), and the Adult Life Satisfaction Scale (ALSS).\n\nThe primary objective was\u002Fis to compare Type D personality characteristics and life satisfaction levels between patients with MDD and BD-II and between their parents. Secondary objectives included\u002Finclude investigating the associations between Type D personality traits, psychiatric symptom severity, and life satisfaction. The findings may contribute to a better understanding of familial psychological characteristics associated with mood disorders and may help identify potential psychosocial targets for preventive and supportive interventions among family members of affected individuals.",[255,29],"Bipolar Disorder II",[257,258,259,260],"Bipolar disorder type II","Major depressive disorder","Life satisfaction","Type D personality","2026-06-25",{"date":263,"type":42},"2026-07-01",{"date":265,"type":42},"2024-12-23",{"date":267,"type":23},"2026-12-24",{"name":269,"class":270},"Elazığ Mental Health and Diseases Hospital","OTHER_GOV",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":24,"phases":281,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":242},"100603693","phase-1-pattern-separation-in-major-depressive-disorder-100603693","NCT07139834","Pattern Separation in Major Depressive Disorder","Examining the Effects of Escitalopram and Memantine on Pattern Separation in Major Depressive Disorder","Inclusion Criteria:\n\n* Age 18-50\n* Current diagnosis of MDD without psychotic features assessed within three weeks of study enrollment\n* 17-item Hamilton Depression Rating Scale score ≥17 assessed within 3 weeks of study enrollment\n* Using an effective form of contraception at study enrollment and agrees to continue throughout study participation for individuals of child-bearing potential\n* Capacity to provide informed consent\n* Proficient in English\n* Willing to provide emergency contact\n\nExclusion Criteria:\n\n* Currently taking an antidepressant medication at study enrollment\n* Pregnant or breastfeeding at time of enrollment\n* Evidence of current unstable medical illness, including liver or renal impairment, or unstable cardiovascular or respiratory illness\n* QTc interval greater than 500 ms\n* Current genitourinary conditions that raise urine pH such as a) renal tubular acidosis or b) severe infection of the urinary tract.\n* Clinically significant neurological conditions, including a) history of stroke, b) previous head injury with evidence of cognitive impairment, c) history of malignancy or d) history of seizure disorder. (headache, migraines, pain disorders, and other conditions not exclusionary)\n* Lifetime diagnosis of a) bipolar disorder, b) psychotic disorder, or c) dementia\n* Current active suicidal ideation\n* Current substance use disorder other than tobacco use disorder\n* Current or recent (past 6 months) treatment with antipsychotics; current or recent (past 1 month) treatment with benzodiazepines; current use of prescribed stimulant medication; current use of other NMDA antagonists (amantadine, ketamine, dextromethorphan)\n* Current use of disulfiram with oral concentrate, MAOIs (including linezolid or IV methylene blue), or pimozide\n* History of hypersensitivity or allergic reaction to a) memantine hydrochloride or any of its components\u002Fexcipients, b) citalopram, escitalopram, or any other component of the product, or c) sertraline or any other component of the product\n* Concurrent or recent (past 6 months) participation in another clinical trial for mental illness involving an investigational product or device\n* Lack of response to or intolerable side-effects from trials of two or more selective serotonin reuptake inhibitors of adequate dose and duration at study enrollment\n* Electroconvulsive therapy (ECT) in the past 6 months\n* Any condition or material in the body that is a contraindication for MRI procedures\n* Weight that exceeds 300 lbs or inability to fit into MRI scanner\n* MST LDI score greater than 0.5","50 Years",{"count":280,"type":23},30,[282],"PHASE1","This study seeks to examine the effects of treatment with a selective serotonin reuptake inhibitor (SSRI), escitalopram, a first-line treatment for depression, in combination with placebo or with extended-release memantine, on neuropsychological function, regional brain activity assessed by functional magnetic resonance imaging, and depressive symptoms, in participants with Major Depressive Disorder. Escitalopram is administered in an open-label fashion in this study; extended release memantine is administered in a double-blind, randomized, placebo-controlled manner.",[29],[68,258,127,286,287],"Pattern separation","Memantine","2026-06-19",{"date":290,"type":42},"2026-06-24",{"date":292,"type":42},"2026-06-01",{"date":294,"type":23},"2027-06-30",{"name":296,"class":82},"Jeffrey Miller",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":304,"maxAge":59,"enrollmentInfo":305,"targetDuration":4,"studyType":24,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100595436","efficacy-of-ktmp-a-novel-non-invasive-brain-stimulation-method-for-the-treatment-of-anhedonia-100595436","NCT07032428","Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia","kTMP Anhedonia","Inclusion Criteria: (1) Patients 21-80 years of age with clinically significant anhedonia, as defined by a SHAPS score of at least 20, and (2) Meet DSM-VTR diagnostic criteria for Major Depressive Disorder.\n\nExclusion Criteria:(1) Reason to anticipate possible hospitalization during the course of the study; (2) Current\u002Fhistory of a psychotic disorder, current manic or mixed episode, meeting the DSM-VTR criteria for bipolar disorder, post-traumatic stress disorder, schizophrenia, at screening, autism spectrum disorders, or mental retardation; (3) Meet DSM-VTR criteria for a substance use disorder within the last year; (4) Current suicidal ideation, suicidal ideation with intent, plan or attempt within the last year, or are considered at significant risk for suicide during the study; (5) Use of any drugs\u002Fmedications that may interfere\u002Finteract with the expected outcomes of the study within 5 half-lives of study participation (see Human Subject section for details); (6) History of seizure; (7) Intracranial expansive process; (8) Pacemaker or any metal implants in head\u002Fneck region; (9) Pregnancy; (10) Uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year; (11) Contraindications for non-invasive brain stimulation or magnetic resonance imaging procedures; (12) Any other condition that in the opinion of the investigator would preclude participation in the study.","21 Years",{"count":306,"type":23},104,[63],"The goal of this proposal is to provide a first assessment of the efficacy of our innovative non-invasive brain stimulation system, kTMP, in the treatment of anhedonia in MDD.",[310,29],"Anhedonia",[312,313,314,69,315,316,317,318,319],"kTMP","NIBS","anhedonia","Cortical Excitability","Plasticity","Neuroscience","reward network","kilohertz Transcranial Magnetic Perturbation","2026-06-18",{"date":322,"type":42},"2026-06-23",{"date":324,"type":23},"2026-07-15",{"date":326,"type":23},"2028-07-30",{"name":328,"class":49},"Magnetic Tides",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":278,"maxAge":59,"enrollmentInfo":337,"targetDuration":4,"studyType":24,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":242},"100628467","lifestyle-interventions-to-prevent-cognitive-deficits-in-subjects-with-depressive-symptoms-from-mechanisms-to-clinical-practice-100628467","NCT07462013","Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice","Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)","POWER","Inclusion Criteria:\n\n* Aged 50-80 years old\n* Major Depressive Disorder\n* Absence or mild cognitive impairment\n\nExclusion Criteria:\n\n\\-",{"count":193,"type":23},[63],"POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).",[29],"2026-06-15",{"date":343,"type":42},"2026-06-17",{"date":345,"type":42},"2025-10-01",{"date":347,"type":23},"2028-09",{"name":349,"class":270},"National Science and Technology Council, Taiwan",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":357,"maxAge":19,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":369,"locationsCount":211},"100634447","phase-2-efficacy-and-safety-of-sertraline-combined-with-lactobacillus-crispatus-in-adolescents-with-depression-100634447","NCT07539805","Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression","Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression : A Multicenter Randomized Controlled Trial","Inclusion criteria\n\n* Aged 12-18 years\n* Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews\n* Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline\n* Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline\n\nExclusion criteria\n\n* Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders\n* MDD with psychotic symptoms\n* Young Mania Rating Scale (YMRS) \\>13 at baseline\n* History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma)\n* Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration\n* History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline\n* Current high suicide risk\n* History of alcohol or drug abuse or dependence\n* Taking or administering antidepressants within 5 half-lives\n* Use of probiotic-related food or medicine within 2 weeks before enrollment\n* Systemic use of antibiotics or antifungals within 1 month before enrollment\n* History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components\n* Adherence to vegetarian or other restrictive dietary patterns\n* Pregnancy or breastfeeding","12 Years",{"count":359,"type":23},60,[26],"The goal of this clinical trial is to evaluate the efficacy and safety of sertraline combined with Lactobacillus crispatus in adolescents aged 12-18 years with major depressive disorder. The main question it aims to answer is: Whether sertraline combined with Lactobacillus crispatus is superior to sertraline combined with placebo in reducing depressive symptoms and improving emotional symptoms in adolescents with depression.\n\nIf there is a comparison group: Researchers will compare sertraline combined with Lactobacillus crispatus with sertraline combined with placebo ( look-alike substance that contains no probiotics) to determine whether the addition of Lactobacillus crispatus provides greater therapeutic benefit in adolescents with depression.\n\nParticipants will: 1. Receive sertraline combined with Lactobacillus crispatus or sertraline combined with placebo for 8 weeks; 2. Attend clinic visits every 4 weeks for clinical assessments and safety monitoring",[29,363],"Probiotic Intervention","2026-06-11",{"date":341,"type":42},{"date":364,"type":42},{"date":368,"type":23},"2028-04",{"name":370,"class":82},"First Affiliated Hospital of Chongqing Medical University",{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":357,"maxAge":19,"enrollmentInfo":378,"targetDuration":4,"studyType":24,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":242},"100643411","phase-2-sertraline-combined-with-multi-strain-probiotics-for-adolescent-depression-100643411","NCT07645157","Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression","A Study on the Efficacy and Safety of Sertraline Combined With Multi-Strain Probiotics in Treating Adolescent Patients With Depression: A Multi-Center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* • Aged 12-18 years\n\n  * Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews\n  * Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline\n  * Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline\n\nExclusion Criteria:\n\n* • Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders\n\n  * MDD with psychotic symptoms\n  * Young Mania Rating Scale (YMRS) \\>13 at baseline\n  * History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma)\n  * Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration\n  * History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline\n  * Current high suicide risk\n  * History of alcohol or drug abuse or dependence\n  * Taking or administering antidepressants within 5 half-lives\n  * Use of probiotic-related food or medicine within 2 weeks before enrollment\n  * Systemic use of antibiotics or antifungals within 1 month before enrollment\n  * History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components\n  * Adherence to vegetarian or other restrictive dietary patterns\n  * Pregnancy or breastfeeding",{"count":193,"type":23},[26],"The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.",[29,363],"2026-06-09",{"date":384,"type":42},"2026-06-12",{"date":386,"type":23},"2026-10-01",{"date":388,"type":23},"2028-10-01",{"name":370,"class":82},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":252,"phases":4,"briefSummary":399,"conditions":400,"keywords":405,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":417,"locationsCount":4},"100643199","serotonin-variants--gut-microbiota-in-mental-health-100643199","NCT07634458","Serotonin Variants & Gut Microbiota in Mental Health","Association Between Serotonin Pathway Genetic Variants and Tryptophan-Metabolizing Gut Microbiota in Adults With Mental Health Conditions: An Observational Pilot Study","Inclusion Criteria:\n\n1. Age: Adults aged 18 to 44 years.\n2. Residency: Current legal residents of the United States.\n3. Clinical Phenotype: Self-report of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Post-Traumatic Stress Disorder (PTSD), or Panic Disorder.\n4. Medication Stability: If currently prescribed psychotropic medications (e.g., SSRIs, SNRIs, benzodiazepines), the dosage must remain stable with no changes in molecule or quantity for at least 3 months prior to enrollment.\n5. Language and Technology: Proficiency in English and access to a smartphone or computer for digital data entry.\n6. Financial Commitment: Explicit agreement to the \"Citizen Science\" model, including payment for discounted testing kits. Kit shipping (both directions) is prepaid by the study.\n\nExclusion Criteria:\n\n1. Use of systemic antibiotics, antifungals, or antivirals within the 8 weeks prior to specimen collection.\n2. Regular use of commercial probiotics or concentrated prebiotic supplements within 4 weeks of collection.\n3. Frequent use of osmotic or stimulant laxatives, or motility agents, within 4 weeks of collection.\n4. Chronic use (\\>3 times\u002Fweek) of NSAIDs, systemic corticosteroids, or high-dose Omega-3 supplementation (\\>2g\u002Fday) within 4 weeks of enrollment.\n5. Use of weight-loss medications or GLP-1 receptor agonists (e.g., semaglutide, liraglutide, tirzepatide) within the 3 months prior to enrollment.\n6. Confirmed diagnosis of Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis), Celiac Disease, or history of major gastric\u002Fintestinal resection.\n7. Current pregnancy or lactation.\n8. Presence of cognitive impairments that preclude the ability to provide informed consent.\n9. Individuals undergoing active cancer treatment.","44 Years",{"count":280,"type":23},"This observational pilot study investigates whether a broad panel of genetic variants relevant to the serotonin pathway (including serotonergic system, methylation cycle, intestinal barrier integrity, and inflammatory response genes) are associated with distinct gut microbiome compositional and functional signatures in adults aged 18-44 years with self-reported mental health conditions (Major Depressive Disorder, Generalized Anxiety Disorder, PTSD, or Panic Disorder).\n\nThis is a decentralized, participant-funded (Citizen Science) study. Eligible participants provide at-home saliva (buccal swab) and stool samples. Genomic analysis is performed using the NeuroBiologix GenePro+ SNP Panel (Illumina Infinium Global Screening Array-24, \\~654,000 SNPs) via Gene By Gene, a CLIA\u002FCAP-accredited laboratory. Gut microbiome analysis is performed by Tiny Health using deep whole-genome shotgun metagenomics (≥20 million reads) on a NextGen Illumina Platform.\n\nThe study is non-interventional and hypothesis-generating, aiming to identify potential genotype-microbiome associations and estimate effect sizes to inform a future interventional trial. N=30 participants. Study Start: July 2026.",[401,402,403,404],"Major Depressive Disorder (MDD","Anxiety Disorder, Generalized","Stress Disorders, Post-Traumatic","Panic Disorder",[406,407,408,409,410,411],"gut microbiome","serotonin","tryptophan metabolism","metagenomics","SNP genotyping","gut-brain axis","2026-06-08",{"date":414,"type":42},"2026-06-10",{"date":263,"type":23},{"date":46,"type":23},{"name":418,"class":49},"Neurobiologix",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":442,"locationsCount":242},"100643449","comparing-outcomes-of-theta-burst-stimulation-in-depression-using-advanced-pet-imaging-100643449","NCT07620288","Comparing Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging","Measuring Neuroplasticity Outcomes of Theta Burst Stimulation in Depression Using Advanced PET Imaging","Inclusion Criteria\n\nFor inclusion in the study, participants must fulfill all the following criteria:\n\n1. 18 to 55 years old.\n2. Competent to provide voluntary informed consent.\n3. English comprehension and verbal communication (participants must be able to both understand and speak English sufficiently to follow study procedures and be understood by study personnel\n4. Referred by their treating physician.\n5. Mini-International Neuropsychiatric Interview-confirmed diagnosis of MDD, as a single or recurring episode.\n6. Symptoms of MDD have not improved after ≥ 1 adequate antidepressant medication trial in the current depressive episode29.\n7. Baseline score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17).\n8. Maintained a stable treatment regimen for at least four weeks prior to entering the study, defined as being on a stable antidepressant regimen, a stable psychotherapy regimen, both, or neither (i.e., no treatment), with no changes during this period.\n\nExclusion Criteria\n\nParticipants fulfilling any of the following criteria will be excluded from the study:\n\n1. Any comorbid mental health disorders (including, but not limited to lifetime history of psychotic disorders, OCD, and\u002For bipolar I or II disorder) with the exception of anxiety\u002Fpanic disorders, posttraumatic stress disorder and ADHD\n2. Current or past (\\\u003C 3 months) substance (including nicotine) or alcohol abuse\u002Fdependence, as defined in DSM-5 criteria.\n3. Positive urine test for illegal substances, cannabis, or cotinine.\n4. Significant unstable medical or neurologic illness confirmed by medical history (e.g. uncontrolled diabetes, or renal dysfunction).\n5. Breastfeeding or pregnant (confirmed via urine test).\n6. BMI \\> 30 or BMI \\\u003C 18.\n7. Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker).\n8. Contraindication for MRI (e.g. metallic implant, claustrophobia).\n9. Have received a cumulative radioactivity dose \\> 15.2mSv during the last 12 months.\n10. Have active malignancies (due to high chance of undergoing radiation therapy).\n11. Suicide attempt in the past three months and\u002For active suicidal intent.\n12. Failed (non-response) course of ECT or rTMS treatment in the current depressive episode.\n13. Benzodiazepine or lithium use. Other psychotropic medications (e.g. ADHD medications) are permitted, if stable in the 4 weeks prior to and during the treatment course)\n14. Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study.","55 Years",{"count":428,"type":23},20,[63],"The proposed project will investigate the neurobiological mechanisms of accelerated intermittent Theta Burst Stimulation (iTBS) in major depressive disorder (MDD) using an advanced multimodal imaging approach. This single-arm, within-subject study will deliver one week of accelerated iTBS and use pre-\u002Fpost-treatment PET\u002FMRI to quantify changes in synaptic density, functional connectivity, and microstructural integrity. We will combine \\[¹⁸F\\]SynVesT-1 PET with functional, neurochemical and anatomical MRI, such as resting-state fMRI, magnetic resonance spectroscopy (MRS) and neurite orientation dispersion and density imaging (NODDI), to capture treatment-related plasticity. This integrated design will link molecular and network-level mechanisms to clinical improvement, providing an unprecedented mechanistic map of how accelerated iTBS restores brain function in depression.",[68,164,432,29],"Depressive Episode",[434,229,435,436,437],"PET","accelerated iTBS","rTMS","MRI","2026-06-05",{"date":382,"type":42},{"date":142,"type":23},{"date":326,"type":23},{"name":443,"class":82},"The Royal Ottawa Mental Health Centre",{"id":445,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":446,"targetDuration":4,"studyType":24,"phases":447,"briefSummary":27,"conditions":448,"keywords":449,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":453,"locationsCount":454},"100614828",{"count":22,"type":23},[26],[29,30],[29,30,32,33,34,35,36,37],{"date":412,"type":42},{"date":44,"type":42},{"date":46,"type":23},{"name":48,"class":49},21,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":462,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":24,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":474,"leadSponsor":476,"locationsCount":4},"100638602","ai-supported-therapy-for-depression-and-anxiety-compared-with-standard-cbt-100638602","NCT07620340","AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT","Evaluating the Efficacy of an AI Delivered, Neurosymbolic, Human Supervised Digital Intervention for Depression and Anxiety Versus Standard Cognitive Behavioural Therapy in Young Persons and Adults","Inclusion Criteria:\n\n* Have symptoms of Generalized Anxiety Disorder (GAD) and\u002For symptoms of --•Major Depressive Disorder (MDD) as the primary reason for seeking treatment (formal diagnosis not required).(as determined by a Psychological Well-being Practitioner).\n* Meet symptom-severity criteria on either validated screening measure:\n* Depression: PHQ-9 (or PHQ-A for young persons) total score between 10 and 19, corresponding to moderate to moderately-severe symptoms, and\u002For\n* Anxiety: GAD-7 total score between 8 and 21, corresponding to mild to severe symptoms.\n* Aged 16-64 years\n* If taking psychotropic medication for depression and\u002For anxiety, be on a stable regimen for at least 6 weeks prior to screening, with no initiation, discontinuation, or dose change during that period.\n* Have reliable access to a compatible, internet-connected device and are able to use it for screening\u002Feligibility, and the intervention and assessments (any potential costs to participants will be clearly noted in the PIS).\n* Possess sufficient English language proficiency and cognitive capacity to engage with the digital therapeutic content and complete questionnaires.\n* Provide informed consent.\n* Willing to be randomised and to participate in a clinically-supervised CBT-based AI programme, including completion of scheduled outcome assessments.\n\nExclusion Criteria:\n\n* Depression: PHQ-9 (or PHQ-A for young persons) total score \\>≥ 20\n* Present with a primary or comorbid diagnosis (or history of) that is unsuitable for a digital CBT-based intervention (as judged by the Investigator), including:\n* Post-traumatic stress disorder (PTSD) or complex trauma\n* Psychotic disorder, bipolar disorder, and\u002For mania\n* Complex or treatment-resistant obsessive-compulsive disorder (OCD)\n* Personality disorder\n* Eating disorder\n* Substance or alcohol use disorder\n* Exhibit high-risk clinical concerns, including:\n* Current suicidal ideation with intent or plan (as indicated by PHQ-9 score and\u002For participant disclosure)\n* Suicide attempt within the past 12 months\n* Ongoing self-harming behaviours\n* Requirement for urgent or crisis mental-health intervention (as indicated by •PHQ-9 score and\u002For participant disclosure)\n* In participants aged 25 years and under, current treatment with an antidepressant medication initiated or dose-adjusted within the past 12 weeks (due to the recognised","16 Years","64 Years",{"count":465,"type":23},400,[63],"This study is a pivotal, randomised, controlled, non-inferiority trial evaluating \"Nook,\" an AI-delivered, neurosymbolic, clinician-supervised digital psychological intervention for depression and anxiety, compared with standard cognitive behavioural therapy (CBT). The trial will recruit 400 participants aged 16-64 years in the UK with moderate depression and\u002For anxiety symptoms. Participants will be randomised to receive either Nook or therapist-delivered CBT.\n\nThe primary objective is to determine whether Nook is non-inferior to CBT in reducing depression and anxiety symptoms, measured using the PHQ-9\u002FPHQ-A and GAD-7 scales. Secondary outcomes include quality of life, functional impairment, sleep quality, treatment engagement, participant satisfaction, safety outcomes, and exploratory health economic measures.\n\nThe intervention incorporates clinician oversight and predefined escalation pathways for suicidality and clinical deterioration. Outcomes will be analysed using longitudinal mixed-effects models under an intention-to-treat framework.",[469,29],"Generalized Anxiety Disorder (GAD)","2026-06-02",{"date":472,"type":42},"2026-06-04",{"date":292,"type":23},{"date":475,"type":23},"2027-01-07",{"name":477,"class":49},"PsyScale",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":24,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":7},"100638488","phase-2-a-study-to-evaluate-tnx-102-sl-monotherapy-versus-placebo-in-participants-with-major-depressive-disorder-mdd-100638488","NCT07621237","A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)","HORIZON","Inclusion Criteria:\n\n* Primary DSM-5 diagnosis of current MDD.\n* The duration of the current MDE must be between 6 weeks and 18 months.\n* Without psychotic or catatonic features.\n* Capable of reading and understanding English and able to provide written informed consent to participate.\n\nExclusion Criteria:\n\n* Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa,\n* Diagnosis of borderline personality disorder that is known, suspected\n* Participants with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD.\n* Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence.\n* History of substance use disorder and\u002For alcohol use disorder during the preceding 12 months\n* Use of antidepressants (including ketamine\u002Fesketamine, St. John's Wort, S-adenosyl methionine, and\u002For trazodone used as an antidepressant) within 4 weeks of Baseline (Visit 2), except for fluoxetine, which must not be within 6 weeks of Baseline (Visit 2)",{"count":91,"type":23},[26],"The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are:\n\nDoes TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL?\n\nResearchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder.\n\nParticipants will:\n\nTake TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests",[490,29,68],"Major Depressive Episode (MDE)",[68,492,493],"TNX-102 SL","Cyclobenzaprine",{"date":470,"type":42},{"date":496,"type":23},"2026-06",{"date":498,"type":23},"2028-02",{"name":500,"class":49},"Tonix Pharmaceuticals, Inc.",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":191,"enrollmentInfo":509,"targetDuration":4,"studyType":24,"phases":510,"briefSummary":511,"conditions":512,"keywords":513,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":522,"locationsCount":211},"100639540","the-effects-of-aerobic-exercise-and-mindful-breathing-on-individuals-with-major-depressive-disorder-in-saudi-arabia-100639540","NCT07625163","The Effects of Aerobic Exercise and Mindful Breathing on Individuals With Major Depressive Disorder in Saudi Arabia","The Effects of Aerobic Exercise and Mindful Breathing on Symptom Severity and Quality of Life in Individuals With Major Depressive Disorder in Saudi Arabia: A Randomised Clinical Trial Protocol","MDD\u002FAE\u002FMB","Inclusion Criteria:\n\n1. Adults aged 18-60 years with a formal diagnosis of Major Depressive Disorder (MDD) based on DSM-5-TR or ICD-10 criteria.\n2. A baseline score of ≥ 17 on the Hamilton Depression Rating Scale (HAM-D) is required to ensure a moderate-to-severe symptom profile\n\nExclusion Criteria:\n\n1. Patients with high suicidal ideation\n2. Patients with a history of psychosis or bipolar disorder\n3. Patient with physical contraindications to exercise (e.g., unstable cardiovascular disease).\n4. Concurrent participation in other structured exercise\u002Fmindfulness trials.",{"count":359,"type":23},[63],"The goal of this Randomized Clinical Trial is to evaluate the effectiveness of aerobic exercise (AE) and mindful breathing (MB) on depressive symptom severity and quality of life (QoL), in adults with MDD. The main question is: Does aerobic exercise and mindful breathing delivery reduce depressive symptom severity and improve quality of life more effectively than standard psychiatric care? The aims to answer are:\n\n1. To determine the effect of aerobic exercise interventions on depressive symptoms of individuals diagnosed with MDD.\n2. To determine the effect of aerobic exercise interventions on health-related quality of life among individuals diagnosed with MDD.\n3. To determine the effect of mindful breathing exercises on depressive symptoms among individuals diagnosed with MDD.\n4. To determine the effect of the mindful breathing exercise intervention on quality of life amongst individuals diagnosed with MDD.\n\nParticipants will be randomized into three groups:\n\n1. 45 minutes of moderate AE (60-75% HRR);\n2. 15 minutes of guided mindful breathing (6 breaths\u002Fminute);\n3. a waitlist control receiving standard care. \\*Interventions will occur three times a week for 16 weeks.",[29],[69,514,515,516,517],"Aerobic Exercise","Mindful Breathing","Quality of Life","Saudi Arabia",{"date":472,"type":42},{"date":341,"type":23},{"date":521,"type":23},"2026-11-14",{"name":523,"class":82},"University of Pretoria",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":190,"sex":18,"minAge":19,"maxAge":191,"enrollmentInfo":530,"targetDuration":4,"studyType":252,"phases":4,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":545},"100636864","identification-and-molecular-characterisation-of-urban-environmental-stress-patterns-affecting-mental-illness-100636864","NCT07571226","Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness","Inclusion Criteria:\n\n1. Diagnosis: The primary diagnosis meets the DSM-IV criteria for depressive disorder, generalized anxiety disorder, or alcohol use disorder, and comorbid conditions may be present;\n2. Patients with mental disorders aged 18-60 years, with a balanced gender ratio;\n3. Normal intelligence and ability to use a smartphone running the Android operating system;\n4. Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;\n5. Participants with depression or generalized anxiety disorder who are taking medication must be on a single stable dose of a selective serotonin reuptake inhibitor (SSRI), specifically citalopram or escitalopram, and this medication regimen must have been maintained for at least 5 days. Participants with alcohol use disorder who are taking medication have no restriction on the type of drug, but the medication regimen should also have been maintained for at least 5 days. At baseline assessment, patients with depression or anxiety disorders should have a Hamilton Depression Rating Scale (HAMD-17) score \\>7 or a Hamilton Anxiety Rating Scale (HAMA-14) score \\>7.;\n6. Voluntary participation in this study and signing of informed consent;\n7. For patients with alcohol use disorder (AUD): AUD patients must have successfully completed alcohol withdrawal, confirmed by clinical standards or relevant healthcare professionals.\n\nInclusion Criteria for Healthy Control Group\n\n1. Healthy subjects aged 18-60 years, with a balanced gender ratio;\n2. Normal intelligence and ability to use a smartphone running the Android operating system;\n3. Willingness to wear a wristband equipped with physiological monitoring functions (such as heart rate and electrodermal activity), download the study application, and upload data during the study period;\n4. Voluntary participation in this study and signing of informed consent.\n\nExclusion Criteria:\n\n1. Currently taking opioid medications;\n2. Receiving any form of brain stimulation therapy within the past 1 month (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);\n3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;\n4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors\u002Finducers;\n5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol;\n6. HAMD-17 item 3 (suicide) \\>3 points (severe suicidal behavior);\n\nExclusion Criteria for Healthy Control Group\n\n1. Currently using benzodiazepines or opioid medications;\n2. Currently receiving any form of brain stimulation therapy (including transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or other similar treatments);\n3. Skin infection or severe skin damage on the wrist or upper limbs that may affect the normal use of monitoring devices;\n4. Recent use (within 30 days) of medications that may interfere with drug metabolism, such as strong CYP450 inhibitors\u002Finducers, or not reaching steady-state drug concentration before the study;\n5. Severe physical diseases (such as brain tumors or injuries) or special conditions (such as current pregnancy or lactation) that may affect the study protocol.",{"count":531,"type":23},680,"Mental disorders have become a major contributor to the global burden of non-communicable diseases, with disability-adjusted life years (DALYs) attributable to these conditions continuing to rise. Although evidence suggests that environmental factors may account for up to 40% of the attributable risk for mental disorders such as major depressive disorder, anxiety disorders, and alcohol use disorder, the underlying mechanisms remain unclear, particularly regarding how dynamic environmental stress influences disease onset, progression, and relapse. Traditional research has primarily focused on individual-level psychosocial factors, including socioeconomic status and life events, while lacking real-time, multidimensional assessments of objective urban environmental stressors such as air pollution, noise exposure, and reduced green space.\n\nThis study proposes a prospective longitudinal cohort design based in real-world environments, enrolling both patients with mental disorders and healthy controls. Using wearable devices integrated with the \"'StreetMind'\" mobile application and wear the visible watch, we will continuously and dynamically collect multimodal data on environmental exposures and physiological responses in urban settings. These include photoplethysmography (PPG)-derived heart rate, oxygen saturation, physical activity, and gait parameters, as well as objective environmental indicators such as temperature, humidity, light intensity, and noise levels. At baseline, all participants will undergo standardized psychiatric assessments to characterize depressive, anxiety, and addictive conditions. Peripheral blood and urine samples will also be collected for subsequent molecular and multi-omics analyses.\n\nThe study aims to systematically evaluate the associations between urban environmental factors-including air pollution, noise exposure, and green space availability-and the risk of mental disorder relapse. Furthermore, it seeks to elucidate the potential mechanisms by which environmental stress affects mental health through neuroinflammation and alterations in brain circuitry. The findings are expected to provide novel insights for risk prediction, early intervention, and precision management of mental disorders.",[29,534,535],"Anxiety Disorder","Alcohol Use Disorder (AUD)","2026-05-31",{"date":538,"type":42},"2026-06-03",{"date":540,"type":42},"2026-04-10",{"date":542,"type":23},"2029-05-30",{"name":544,"class":82},"Huashan Hospital",3,{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":242},"100637106","efficacy-and-safety-of-transcranial-temporal-interference-stimulation-for-depression-100637106","NCT07612501","Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression","Inclusion Criteria:\n\n* Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists\n* 24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline\n* Aged 18 to 65 years\n* Right-handed\n* Able to understand the study procedures and willing to provide written informed consent\n\nExclusion Criteria:\n\n* History of epilepsy, brain tumor, or brain trauma\n* Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months\n* Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging\n* Acute or severe suicidal ideation\n* Any other condition judged by the investigators to make participation unsuitable for this study",{"count":359,"type":23},[63],"The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function.\n\nThe main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS.\n\nResearchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment.\n\nParticipants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.",[29],[69,557,558,559,560,561],"Transcranial Temporal Interference Stimulation","Noninvasive Brain Stimulation","Anterior Limb of the Internal Capsule","Subgenual Anterior Cingulate Cortex","Magnetic Resonance Imaging","2026-05-27",{"date":564,"type":42},"2026-05-28",{"date":566,"type":23},"2026-05-30",{"date":568,"type":23},"2027-05-30",{"name":570,"class":82},"Yonggui Yuan",{"id":572,"slug":4,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":125,"conditions":576,"keywords":577,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":582,"locationsCount":147},"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":123,"type":23},[26],[127,29,128,129,130],[132,133,134,135,136,137,138,139],"2026-05-22",{"date":564,"type":42},{"date":142,"type":23},{"date":144,"type":23},{"name":146,"class":82},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":591,"enrollmentInfo":592,"targetDuration":4,"studyType":24,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":211},"100639900","phase-2-a-study-to-evaluate-the-effectiveness-of-dt-101-as-an-adjunctive-treatment-in-patients-with-depression-100639900","NCT07610473","A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression","A Phase 2 Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder Receiving Pharmacological Therapy for Depression","AERON-1","Inclusion Criteria:\n\nThe participant is able to read, understand and communicate in the local language used at the study site, and is willing to provide written informed consent Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age, inclusive at the time of signing the informed consent.\n\nHas recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022).\n\nExclusion Criteria:\n\nPregnant or breastfeeding or plans to become pregnant during the study. Unstable medical condition or unstable chronic disease. Significant neurological abnormality. History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening.\n\nHistory of seizure. In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.","75 Years",{"count":593,"type":23},118,[26],"In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.",[29],[127,68,598,599,600,69],"DT-101","Randomized","Placebo Controlled","2026-05-21",{"date":564,"type":42},{"date":604,"type":23},"2026-05",{"date":606,"type":23},"2027-05",{"name":608,"class":49},"Draig Therapeutics Ltd",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":617,"targetDuration":4,"studyType":24,"phases":619,"briefSummary":620,"conditions":621,"keywords":623,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":242},"100637249","accelerated-itbs-for-major-depression-100637249","NCT07603804","Accelerated iTBS for Major Depression","Investigation of the Relationship Between Changes in Neurobiological Biomarkers After Accelerated Transcranial Magnetic Stimulation Treatment and Treatment Response in Patients With Major Depressive Disorder","AIM-D","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Diagnosis of Major Depressive Disorder according to DSM-5 criteria\n* Inadequate response to at least one adequate antidepressant treatment trial\n* Hamilton Depression Rating Scale (HAM-D) score ≥14 at baseline\n* Stable dose of antidepressant medication for at least 4 weeks prior to study entry\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic depression\n* Current substance use disorder\n* Neurological disorders that may affect brain function (e.g., epilepsy, multiple sclerosis, dementia, Parkinson's disease)\n* History of epileptic seizures\n* Severe head trauma\n* Presence of metal implants in the head or neck region\n* Cochlear implants\n* Cardiac pacemaker or implanted electronic devices\n* History of deep brain stimulation or vagus nerve stimulation\n* Previous neurosurgical procedures\n* Pregnancy or breastfeeding\n* Use of medications that may significantly affect neuroendocrine or inflammatory markers (e.g., corticosteroids, immunomodulators)\n* Endocrine disorders affecting the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, Addison's disease, thyroid disorders)\n* Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, Hashimoto thyroiditis)\n* Recent surgery or acute infection\n* Active suicidal crisis, severe agitation, or inability to comply with study procedures",{"count":618,"type":23},35,[63],"Major depressive disorder (MDD) is a common and disabling psychiatric condition, and many patients do not achieve adequate response to standard antidepressant treatments. Accelerated intermittent theta burst stimulation (iTBS) is a promising neuromodulation approach that may provide rapid antidepressant effects. This prospective interventional study aims to evaluate the clinical effectiveness of accelerated bilateral dorsomedial prefrontal cortex iTBS in patients with MDD and to investigate treatment-related changes in neurobiological biomarkers, including cortisol, ACTH, BDNF, IL-1β, IL-6, TNF-α, and CRP. Associations between biomarker changes and treatment response will also be examined.",[29,622],"Treatment Resistant Depression (TRD)",[69,624,68,72,71,625,229,626,627,628,629,630,631,632,633],"Treatment Resistant Depression","Intermittent Theta Burst Stimulation","Accelerated TMS","Accelerated iTBS","Dorsomedial Prefrontal Cortex","Biomarkers","Neuroinflammation","BDNF","Cortisol","ACTH",{"date":578,"type":42},{"date":636,"type":42},"2026-03-08",{"date":638,"type":23},"2026-12-31",{"name":640,"class":82},"Istanbul University - Cerrahpasa",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":649,"enrollmentInfo":650,"targetDuration":4,"studyType":252,"phases":4,"briefSummary":652,"conditions":653,"keywords":654,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":668},"100573428","predictors-of-relapse-in-major-depressive-disorder-perform-d-100573428","NCT06746155","Predictors of Relapse in Major Depressive Disorder (PERFORM-D)","Predictors of Early Relapse During Follow-up Of Remitted Major Depression","PERFORM-D","Inclusion Criteria:\n\n* Outpatients 18 to 70 years of age.\n* Meet DSM-V criteria for MDD as determined by the SCID-5 or other standardized clinical interviews.\n* In the current or most recent MDE, participant must be responding or responded to a treatment or a combination of treatments for MDD. Patients with remitted MDD who are currently not taking medications will also be accepted. Patients must have achieved remission at or later than May 1, 2023.\n* Participants must have a MADRS total score ≤14.\n* Participant must be willing and able to complete self-reported assessments including sufficient fluency in English.\n* Participant must be willing to wear the wrist-worn actigraphic device for the duration of the study.\n\nExclusion Criteria:\n\n* Bipolar I or Bipolar-II diagnosis (lifetime), schizophrenia, or schizoaffective disorder.\n* Elevated risk of suicide, as determined by clinical evaluation.\n* Existence of major neurological disorders, head injury (if accompanied by any of \\[A\\] loss of consciousness longer than 24 hours, \\[B\\] documented evidence of Glasgow Coma Scale \\\u003C9 at the time of injury, \\[C\\] post-traumatic amnesia lasting longer than 24 hours) (43), or other unstable medical conditions.\n* The participant presents with any condition which, according to the researcher's judgment, could interfere with the assessments stipulated in the protocol.\n* The participant is employed by the researcher, actively involved in the current study or other research overseen by the same researcher, or is a relative of a study employee or the researcher.","70 Years",{"count":651,"type":23},252,"Major depressive disorder (MDD) is a common condition involving recurring periods of depression. One of the major challenges faced by people with MDD is that the episodes of depression tend to recur even after they are successfully treated. Currently, it is hard to predict when a depressive episode will recur. Being able to forecast this would help healthcare providers monitor patients and prevent relapse.\n\nThe purpose of this study is to monitor features such as clinical symptoms, physical activity, sleep patterns, cognitive functioning and brain activity to help us understand how relapse happens and the mechanisms that cause it. From these different types of data, investigators will build a model that tells us who is more likely to experience a relapse and when the relapse is likely to occur.\n\nThis study will be a significant step forward in understanding and managing MDD. Investigator will create a practical tool that will allow healthcare providers to monitor patients more effectively. By identifying early signs of relapse, investigators may be able to intervene promptly to prevent depressive episodes. Finally, our research will help understand the factors that underlie relapse in MDD, which will encourage the development of novel treatment approaches.",[29],[69,655,656,629,657,658,659],"Remission","Follow-up","Relapse","Clinical predictors","Relapse prediction","2026-05-20",{"date":578,"type":42},{"date":663,"type":42},"2024-12-27",{"date":665,"type":23},"2029-10-01",{"name":667,"class":82},"Abraham Nunes",8]