[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"depressive-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:depressive-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,68,0,25,[9,44,79,106,136,178,202,225,256,278,298,323,350,368,395,424,454,480,508,535,560,582,611,635,646],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054287","an-innovative-master-platform-for-clinical-trials-in-mood-disorders-100054287",false,"NCT06408012","An Innovative Master Platform for Clinical Trials in Mood Disorders","Enabling Neuroscience Research Approaches for Brain, feeLings and Emotions (ENABLE): An Innovative Platform for Clinical Trials in Mood Disorders","ENABLE","Inclusion Criteria\n\nPatients:\n\n1. 16 years of age or older.\n2. Meet criteria for bipolar or depressive disorders as defined by DSM-5.\n3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.\n\nInclusion Criteria\n\nHealthy Comparison (HC) Participants:\n\n1. 16 years of age or older.\n2. No history of psychiatric disorders (according to DSM-5) or significant unstable medical conditions.\n3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.",true,"ALL","16 Years",{"count":22,"type":23},2200,"ESTIMATED","1 Day","OBSERVATIONAL","Mood disorders such as depression and bipolar disorder affect over 350 million people around the world. While several effective treatments exist, it is often difficult to match the right treatment to an individual person. Repeated efforts to find the right treatment contribute to poor functioning, low quality of life, and prolongs the time it takes to get well. Most areas of medicine are able to use 'biomarkers' or clinical tests, blood tests, or imaging to help diagnose and treat illness. The search for biomarkers in mood disorders is advancing, but one roadblock to progress is the lack of large, standardized studies of mood disorders that are needed to accurately identify biomarkers. The aim of the ENABLE platform is to provide the Canadian neuroscience community a standardized way of collecting biomarker data from individuals with a range of mood disorders symptoms. In addition, this 'master clinical trial platform' framework will provide a pool of participants who can be recruited into biomarker-based clinical trials.",[28,29,30],"Mood Disorders","Depressive Disorder","Bipolar and Related Disorders","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2023-10-17",{"date":39,"type":23},"2029-03-31",{"name":41,"class":42},"St. Joseph's Healthcare Hamilton","OTHER",9,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100645295","effectiveness-of-the-group-unified-protocol-for-emotional-disorders-in-adults-in-a-public-mental-health-setting-100645295","NCT07682064","Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting","Effectiveness of the Group Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al. 2011, 2019a, 2019b) in Adults in a Public Mental Health Setting","PSIGTE","Inclusion Criteria:\n\n* Aged 18 to 65 years.\n* Ability and willingness to provide written informed consent.\n* Sufficient proficiency in Spanish to participate in the intervention and complete study assessments.\n* Sufficient cognitive capacity to understand the intervention content.\n* A primary diagnosis of an emotional disorder with mild, moderate, or severe symptom severity, including Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive and Related Disorders, Trauma and Stressor-Related Disorders, Dissociative Disorders and Somatic Symptom and Related Disorders.\n* Presence of emotional symptoms (e.g., anxiety, depressive, or phobic symptoms), somatic symptoms, obsessive symptoms, and\u002For avoidance behaviors associated with clinically significant impairment, as indicated by moderate or higher scores on the GAD-7, PHQ-9, and\u002For PHQ-15.\n\nExclusion Criteria:\n\n* Refusal to provide informed consent or withdrawal of consent during the study.\n* Current severe substance use disorder or behavioral addiction.\n* Current high suicide risk.\n* Current psychotic symptoms or psychotic disorder.\n* Neurological disorders or severe medical conditions that could interfere with participation in or adherence to the intervention.\n* Intellectual disability, significant language difficulties, or any other condition that may impair the participant's ability to understand the intervention content.","18 Years","65 Years",{"count":55,"type":23},106,"INTERVENTIONAL",[58],"NA","This study has three primary objectives:\n\n1. To adapt the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011, 2019a, 2019b) for delivery in a group format within the Spanish Public Mental Health System for adults diagnosed with emotional disorders.\n2. To evaluate the effectiveness of the intervention.\n3. To assess its clinical feasibility and acceptability in routine clinical practice.\n\nOutcomes will include anxiety, depression, somatic symptoms, transdiagnostic variables, functional impairment, quality of life, and participant satisfaction. These outcomes will be assessed at baseline, post-treatment, and 3-month follow-up.\n\nThe intervention is expected to improve emotional symptoms, functional impairment, and quality of life. In addition, the study will explore whether this group-based transdiagnostic approach may help lower demand on public mental health services.",[61,62,29,63],"Emotional Disorders","ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)","Somatic Disorders",[65,66,67,68],"Unified Protocol","emotional disorder","UP","treatment","2026-06-30",{"date":71,"type":35},"2026-07-02",{"date":73,"type":35},"2024-04-27",{"date":75,"type":23},"2026-12",{"name":77,"class":42},"Patricia Fernández Couto",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":56,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":78},"100531932","the-oh-happy-day-class---digital-connections-ohdc-dc-a-pilot-study-100531932","NCT06206226","The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study","The Oh Happy Day Class - Digital Connections (OHDC-DC): an Exploratory Pilot Study","OHDC-DC","Inclusion Criteria:\n\n* African-American\n* Age 18 and older\n* Experiencing depression (as evidenced by a score of 5 or higher on the PHQ-9)\n* Own a mobile phone\n\nExclusion Criteria:\n\n* Individuals who are currently receiving psychotherapy\n* Individuals who are presently experiencing suicidal ideation\n* Individuals who started psychotropic medication less than three months prior to the start of the OHDC will be excluded from the study\n* Participants scoring 25 or higher on the PHQ-9 will be screened out",{"count":88,"type":23},8,[58],"The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression.\n\nParticipants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.",[92,29,93],"Depression","Depressive Symptoms",[95],"African American","NOT_YET_RECRUITING","2026-06-29",{"date":99,"type":35},"2026-07-01",{"date":101,"type":23},"2026-07",{"date":103,"type":23},"2027-02",{"name":105,"class":42},"University of Wisconsin, Madison",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":56,"phases":114,"briefSummary":115,"conditions":116,"keywords":124,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":78},"100627856","efficacy-of-transcutaneous-auricular-vagus-nerve-stimulation-on-alleviating-major-depressive-disorder-in-patients-with-acute-coronary-syndrome-after-percutaneous-coronary-interventiona-prospective-double-blindrandomized-controlled-study-100627856","NCT07454070","Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Meeting the diagnostic criteria for ACS\n* 14 days to 12 months after successful PCI, with stable vital signs\n* Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)\n* HAMD-17 score ≥7 and \\\u003C24 (mild-to-moderate depression), with HAMA score \\\u003CHAMD score;\n* Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent\n* Voluntary participation in the study and signing of the informed consent form\n\nExclusion Criteria:\n\n* Severe heart failure (New York Heart Association \\[NYHA\\] class ≥III)\n* Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg)\n* Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per minute, RR interval ≥3 s) or a history of syncope unrelated to the current ACS\n* Dialysis-dependent patients\n* Previous renal sympathetic denervation or vagal ganglion ablation\n* Expected survival time \\\u003C4 months\n* Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse\n* Current use of antipsychotic medications\n* High suicide risk\n* Pregnant or lactating women\n* Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment\n* Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)",{"count":113,"type":23},120,[58],"This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study.\n\nPatients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up.\n\nAll treatments were self-administered by the patients at home after they received training from the hospitals.\n\nThe primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .",[117,118,119,29,120,121,122,123],"Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate)","Acute Coronary Syndrome (ACS)","Percutaneous Coronary Intervention (PCI)","Postoperative Psychological Distress","Heart Rate Variability (HRV)","Inflammatory Factors","Randomized Controlled Trial (RCT)",[125,118,126],"Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Post-Percutaneous Coronary Intervention (PCI) Psychological Distress","2026-06-14",{"date":129,"type":35},"2026-06-16",{"date":131,"type":35},"2026-01-06",{"date":133,"type":23},"2026-08-10",{"name":135,"class":42},"Jing Han",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":56,"phases":146,"briefSummary":148,"conditions":149,"keywords":160,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":78},"100555424","phase-2-investigation-of-the-antidepressant-effects-of-2r6r-hnk-an-enhancer-of-synaptic-glutamate-release-in-treatment-resistant-depression-100555424","NCT06511908","Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","An Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \\>= 80% on the consent quiz.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. 18 to 70 years of age.\n4. All participants must have undergone a screening assessment under protocol 01-M-0254.\n5. Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants must be experiencing a current major depressive episode lasting at least two weeks.\n6. Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\\u003C12 within one week of study entry and upon entry into Phase II.\n7. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.\n8. Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode, operationally defined using the modified Antidepressant Treatment History Form (ATHF); non-response to an adequate trial of ECT or TMS would count as an adequate antidepressant trial.\n9. For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II.\n10. For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.\n11. Agreement to adhere to Lifestyle Considerations throughout study duration.\n12. Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.\n2. Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.\n3. Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.\n4. Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.\n5. Ongoing treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers\n6. Lifetime history of deep brain stimulation.\n7. Previous antidepressant non-response to ketamine or esketamine (full course).\n8. No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.\n9. Pregnancy or lactation.\n10. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n11. Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to starting Phase II. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician. Due to the interactions between cannabis and SSRIs, frequent cannabis use during previous antidepressant treatment will result in that treatment being considered a failed trial for eligibility purposes.\n12. Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.\n13. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).\n14. No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely participate in the study: Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver, any liver disease with Child-Pugh score \\>=5), cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug), renal\u002Furologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis, moderate to severe renal impairment of any etiology), endocrinologic (including uncontrolled diabetes due to association with progressive abnormality of the microvasculature and nervous system), or neurologic disease (e.g. elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n15. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n16. Participants with one or more seizures without a clear and resolved etiology.\n17. Clinically significant abnormal laboratory tests specifically defined by:\n\n    * Alkaline phosphatase (Alk Phos) \\> 150 U\u002FL\n    * Alanine aminotransferase (ALT) \\> 55 U\u002FL\n    * Aspartate aminotransferase (AST) \\> 34 U\u002FL\n    * Total bilirubin (TB) \\> 1.2 mg\u002FdL\n    * Direct bilirubin (DB) \\> 0.5 mg\u002FdL\n    * 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n    * Folate \\\u003C 2ng\u002FmL\n    * Vitamin B12 \\\u003C 200 pg\u002FmL\n18. Moderate to severe renal impairment with body surface area corrected eGFR \\\u003C60mL\u002Fmin.\n19. Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.\n20. Positive HIV test.\n21. Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)\n22. Participants with COVID-19 or suspected COVID-19\n23. Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.","70 Years",{"count":145,"type":23},50,[147],"PHASE2","Background:\n\nMajor depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.\n\nObjective:\n\nTo test a study drug (HNK) in people with MDD.\n\nEligibility:\n\nPeople aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.\n\nHNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:\n\nThey will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.\n\nThey will receive no drugs for 2 to 3 weeks.\n\nThey will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.\n\nOne set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.\n\n...",[150,151,152,153,154,155,156,157,29,92,158,28,159],"Suicide","Depressive Disorder, Treatment-Resistant","Ketamine","Molecular Mechanisms of Pharmacological Action","Neurotransmitter Agents","Excitatory Amino Acid Agents","Physiological Effects of Drugs","Depressive Disorder, Major","Mental Disorders","Behavioral Symptoms",[161,152,162,163,164,165,166,167,168],"Major Depressive Disorder","Biomarkers","Neuropharmacology","Magnetic Resonance Imaging","Magnetoencephalography","Neurobiology","Glutamate","Hydroxynorketamine","2026-06-13",{"date":129,"type":35},{"date":172,"type":35},"2024-11-06",{"date":174,"type":23},"2027-07-01",{"name":176,"class":177},"National Institute of Mental Health (NIMH)","NIH",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":19,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":56,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":78},"100642990","feasibility-study-of-up-a-ast-parent-group-for-adolescents-with-autism-and-co-occurring-anxietydepression-100642990","NCT07637799","Feasibility Study of UP-A-AST Parent Group for Adolescents With Autism and Co-occurring Anxiety\u002FDepression","Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) for Adolescents With Autism Spectrum Disorder and Co-occurring Anxiety and\u002For Depressive Disorders: A Feasibility Study","Inclusion Criteria:\n\n* Adolescents aged 12-17 years\n* Clinical diagnosis of autism spectrum disorder (ASD) according to DSM-IV, DSM-5, or ICD-10\n* Current diagnosis of anxiety disorder and\u002For depressive disorder according to DSM-5\n* Ongoing contact with a Child and Adolescent Psychiatry (BUP) outpatient clinic\n* Stable psychopharmacological treatment at the time of inclusion (if applicable)\n* Parents has participated in a psychoeducational program on autism within child and adolescent psychiatric services, or is assessed by the clinician to have equivalent knowledge\n\nExclusion Criteria:\n\n* Presence of a severe psychiatric disorder, such as psychotic disorder, bipolar disorder, or severe eating disorder\n* High suicide risk or suicide attempt within the past 12 months\n* Severe self-injurious behavior\n* Intellectual disability according to DSM-5\n* The adolescent is primarily in need of basic interventions for autism spectrum disorder\n* Parents are unable to attend all group sessions and\u002For lack the ability to engage in assigned home practice\n* Need for an interpreter","12 Years",{"count":187,"type":23},72,[58],"Autism spectrum disorder (ASD) is associated with high rates of psychiatric comorbidity, particularly anxiety and depressive disorders, which contribute to significant impairment for affected youth and their families. Although cognitive behavioral therapy (CBT) is recommended as a first-line treatment for anxiety and depression in children and adolescents, there is a lack of evidence-based interventions specifically adapted for youth with ASD and co-occurring emotional disorders.\n\nThe Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C\u002FUP-A) is a CBT-based intervention targeting shared mechanisms underlying anxiety and depression. A parent-mediated adaptation, the Unified Protocol-Adolescent Autism Parent Group (UP-A-AST), has been developed to address the specific needs of adolescents with ASD and co-occurring anxiety and\u002For depressive disorders. Preliminary quality improvement work has shown promising results.\n\nThis study aims to evaluate the feasibility, acceptability, and preliminary effects of the UP-A-AST Parent Group in a child and adolescent outpatient psychiatric setting. The study will include parents of adolescents aged 12-17 years with ASD and co-occurring anxiety and\u002For depressive disorders. Outcomes include changes in adolescents' psychiatric symptoms and functional impairment, as well as parents' perceived parenting competence. Additionally, parents' experiences of participating in the intervention will be explored.",[191,192,29],"Autistic Spectrum Disorder","Anxiety Disorders","2026-06-09",{"date":195,"type":35},"2026-06-10",{"date":197,"type":35},"2026-01-05",{"date":199,"type":23},"2027-03-30",{"name":201,"class":42},"Sahlgrenska University Hospital",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":19,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":56,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":78},"100513239","development-of-a-transdiagnostic-intervention-for-adolescents-at-risk-for-serious-mental-illness-100513239","NCT05962879","Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness","Inclusion Criteria:\n\n* Currently enrolled in 9th through 12th grade and between the ages of 14 and 19\n* Endorsed at least one psychotic experience\n* Provided contact information\n* Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)\n* Have a parent or legal guardian who is able and willing to participate in a parent session\n* Competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older)\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Currently prescribed psychotropic medication (not including medications for attention deficit\u002Fhyperactivity disorder), regardless of adherence\n* Currently obtaining psychotherapeutic intervention","14 Years","19 Years",{"count":211,"type":23},70,[58],"This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.",[192,215,29,216],"Psychotic Disorders","Psychosocial Functioning",{"date":218,"type":35},"2026-06-11",{"date":220,"type":35},"2024-03-22",{"date":222,"type":23},"2027-05-31",{"name":224,"class":42},"Massachusetts General Hospital",{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":18,"sex":19,"minAge":233,"maxAge":52,"enrollmentInfo":234,"targetDuration":4,"studyType":56,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":78},"100642699","study-on-mental-health-promoting-effects-of-natural-psychotherapy-for-adolescents-100642699","NCT07639476","Study on Mental Health Promoting Effects of Natural Psychotherapy for Adolescents","The Effect of Universal Intervention Based on Natural Psychotherapy: Evidence From Chinese Adolescents","NP-A-MHP","Inclusion Criteria:\n\n* Ages: 7 to 18 years.\n* Population: School-aged children and adolescents currently enrolled and attending primary or secondary school.\n* Capacity: Ability to comprehend the study procedures and provide assent (or consent, if applicable).\n\nExclusion Criteria:\n\n* School Attendance: Children not currently attending school or on long-term academic leave.\n* General Exclusion: Any condition that, in the opinion of the investigator or school physician, would interfere with the participant's ability to attend school or comply with study procedures.","7 Years",{"count":235,"type":23},3000,[58],"This randomized controlled trial aims to evaluate the efficacy of a universal intervention based on Natural Psychotherapy in reducing anxiety and depressive symptoms among primary and middle school students. To evaluate both the clinical outcomes and the potential underlying mechanisms of change, data will be collected at four distinct time points: baseline (pre-intervention), post-intervention, 3-month follow-up, and 6-month follow-up.",[192,29,239],"Mental Health",[241,92,242,243,244,245,246,247],"Mindfulness","Emotional Regulation","Cognitive Flexibility","Primary School Students","Middle School Students","Feasibility","Natural Psychotherapy","2026-06-06",{"date":195,"type":35},{"date":251,"type":23},"2026-09-15",{"date":253,"type":23},"2027-12-31",{"name":255,"class":42},"Beijing HuiLongGuan Hospital",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":53,"enrollmentInfo":263,"targetDuration":4,"studyType":56,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":78},"100515280","adaptation-of-individual-dialectical-behavior-therapy-intervention-for-transdiagnostic-treatment-of-emotional-disorders-100515280","NCT05989451","Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders","Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders in Two Medical Centers: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Mandarin Chinese-language proficiency sufficient to complete the study questionnaire\n2. A current diagnosis of depressive or anxiety disorder as diagnosed from a SCAN interview\n\nExclusion Criteria:\n\n1. Intellectual disability\n2. Substance use disorder in the past three months\n3. Bipolar disorder\n4. Psychotic disorder\n5. Organic brain disorder\n6. Acute suicidality or a history of frequent or recent suicide attempts\n7. Recent (past six weeks) change in psychiatric medication or unwillingness to maintain a stable dosage of medication during study participation\n8. Had received five or more sessions of CBT in the past five years or was unwilling to stop concurrent psychotherapy for an emotional disorder\n9. Any mental or physical condition requiring hospital admission\n10. Another medical condition likely to prevent participation in the study\n\nAs we also aim for a naturalistic setting, we do not exclude patients who undergo a medication change during the trial if this is judged necessary or clinically important by the treating clinician. Instead, we include a question about this in the questionnaire to the referring\u002Ftreating clinician.",{"count":264,"type":23},250,[58],"Anxiety and depressive disorders, referred to as emotional disorders, have high rates of prevalence, recurrence, and functional impairment. Transdiagnostic psychotherapy targeting shared features of these disorders has recently emerged. Dialectical behavior therapy (DBT) for the transdiagnostic treatment of emotional disorders is a promising approach, as results of preliminary studies for use in a broad range of mental disorders are encouraging. Since there is a lack of research on transdiagnostic psychotherapy in Taiwan, the investigators thus propose this 3-year randomized controlled trial to test the efficacy of a modified DBT for the treatment of transdiagnostic emotional disorders and to further evaluate whether the efficacy of modified DBT differs in the specific emotional disorders. The investigators expect that patients with emotional disorders receiving modified DBT are more likely to improve clinical outcomes, functioning, and quality of life.",[268,29],"Anxiety Disorder","2026-05-27",{"date":271,"type":35},"2026-05-29",{"date":273,"type":35},"2023-09-01",{"date":275,"type":23},"2026-10",{"name":277,"class":42},"Mackay Memorial Hospital",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":4},"100640081","assessing-the-impact-of-the-personalized-medicine-clinic-on-mental-health-outcomes-100640081","NCT07601477","Assessing the Impact of the Personalized Medicine Clinic on Mental Health Outcomes","Inclusion Criteria:\n\n* Depressive symptoms\n\nExclusion Criteria:\n\n* Patients who do not speak English\n* Patients with severe mental illness including hospitalized patients or patients with suicidal ideation",{"count":285,"type":23},200,"The aim of this study is to investigate if personalized dosing of antidepressant medications using information gathered at the Personalized Medicine Clinic can improve patients' mental health. The main question it aims to answer is if the Personalized Medicine Clinic can improve depressive symptoms based on the CES-D survey score.",[239,29,288,289],"Pharmacogenetic Testing","Antidepressant","2026-05-21",{"date":292,"type":35},"2026-05-26",{"date":101,"type":23},{"date":295,"type":23},"2028-06",{"name":297,"class":42},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":19,"minAge":304,"maxAge":53,"enrollmentInfo":305,"targetDuration":4,"studyType":56,"phases":307,"briefSummary":308,"conditions":309,"keywords":313,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":78},"100499654","phase-2-the-impact-of-ampa-receptor-blockade-on-ketamines-anti-suicidal-effects-100499654","NCT05786066","The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects","Inclusion Criteria:\n\n* Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale (HDRS-17) AND current major depressive episode as determined by structured clinical interview (SCID-5)\n* Current suicidal ideation as indicated by a score ≥ 2 on the HDRS-17 Item #3 (\"wishes to be dead (or any thoughts of possible death to self)\")\n* Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials\n* Participants will meet DSM-5 Criteria for MDD, PTSD or Bipolar Disorder as determined by the SCID-5\n* All participants given Ketamine must be engaged in mental health treatment outside of the research protocol. Those who are not receiving treatment with a mental health provider at the time of the phone screen may be referred for treatment and will have their admission to the protocol deferred until they are receiving treatment with a mental health provider for at least 4 weeks, at which time they may re-apply for admission to the protocol.\n* Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. Those who are not stable on their current medication and dose for 4 weeks at the time of the phone screen may have their admission to the protocol deferred until they are stable on their current psychopharmacotherapy. In addition, all individuals admitted to the protocol should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.\n* Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial. Those who are not stable on their current regime of psychotherapy for 4 weeks at the time of the phone screen may have their admission to the protocol deferred until they are stable on their current regime of psychotherapy.\n* Willing to refrain from caffeine, drug, and alcohol use for one week prior to each Ketamine infusion\n* Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy). Women who are surgically sterile or post-menopausal with cessation of menses for at least one year are not required to use birth control. If a woman should become pregnant during the study, she will be excluded from the trial.\n* Females will receive Ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps during this entire follicular phase, she will be studied during another part of her cycle. She will be studied during the same part of her cycle for each scan, if possible.\n* Able to read and write English\n* Have at least a 12th grade education level or equivalent\n\nExclusion Criteria:\n\n* A score on the Columbia-Suicide Severity Rating Scale \\[43\\] in the \"intent\" or \"intent with plan\" categories within the last 3 months or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.\n* Psychiatric hospitalization in the past two months\n* Suicide attempt in the past two months\n* Neurological disorder excluding migraine headaches or mild head injury. More than mild head injury is indicated by the presence of any of the following:\n\n  * More than half hour unconsciousness after trauma\n  * More than one hour post-traumatic amnesia\n  * Concussive symptoms such as headache, memory problems, nausea\u002Fvomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.\n  * Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.\n  * Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.\n* Current therapeutic treatment with Ketamine\n* Previous trial of Ketamine without therapeutic benefit\n* Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization\n* Daytime use of benzodiazepines\n* Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization\n* Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization\n* Psychosis other than psychotic experiences congruent with depressed mood during a period of depression. Individuals experiencing psychosis during the current depressive episode will be excluded.\n* Other major medical disorder unless cleared by a study physician\n* History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable sobriety with no violent incidents or an individual who had received successful pharmacotherapy for impulse control difficulties may be included.\n* Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to screening date may be included in the study at investigator discretion. The diagnosis of mild alcohol use disorder shall be per DSM-5 and involve 2-3 symptoms. The PI's discretion will be based on the symptoms that are reported and the judged consistency and accuracy of the subjects' self-report.\n* A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the infusion visits.\n* A positive screening alcohol breathalyzer or alcohol saliva test or, at the study physicians' discretion, on any alcohol breathalyzer or alcohol saliva test given before the infusion visits.\n* A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.\n* Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the study physician considers that such findings will not introduce additional risk factors.\n* History of positive HIV or Hepatitis B\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the Ketamine infusion visit. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinions of the Principal\u002FCo-Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Known sensitivity to Ketamine or heparin\n* Resting blood pressure lower than 85\u002F55 or higher than 140\u002F90, or resting heart rate lower than 45\u002Fmin or higher than 100\u002Fmin, unless cleared by study physician. If a subject meets these blood pressure entrance criteria, but is being treated for high blood pressure, the study team will check with the subject's primary care physician or treatment provider to confirm that the subject is stable and normotensive on their current treatment plan.\n* History of general intellectual disability\n* Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.\n* Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.","21 Years",{"count":306,"type":23},30,[147],"The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).",[29,161,310,311,312],"Bipolar Disorder","Post Traumatic Stress Disorder","Suicidal Ideation",[152,150],"2026-05-05",{"date":316,"type":35},"2026-05-06",{"date":318,"type":35},"2023-04-03",{"date":320,"type":23},"2033-03",{"name":322,"class":42},"Yale University",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":53,"enrollmentInfo":330,"targetDuration":4,"studyType":56,"phases":332,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":346,"leadSponsor":348,"locationsCount":4},"100636194","pb-18-probiotic-for-mild-to-moderate-depression-100636194","NCT07562516","PB-18 Probiotic for Mild to Moderate Depression","A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Efficacy and Safety of Bifidobacterium PB-18 in Adults With Mild to Moderate Depressive Disorder and to Explore Its Gut-Brain Axis Mechanisms","Inclusion Criteria:\n\n* Outpatient or inpatient participants, aged 18 to 65 years (inclusive), of any sex\n* Current episode meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for depressive disorder\n* Baseline score on the 17-Item Hamilton Depression Rating Scale is 7 to 24, inclusive\n* No concomitant use of antidepressants or other psychotropic medications during the study\n* Elementary school education or above, able to understand the study requirements and complete the rating scales\n* Participant personally signs the informed consent form and is willing to complete follow-up according to the study protocol\n\nExclusion Criteria:\n\n* Current or past diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria, of bipolar disorder, schizophrenia spectrum and other psychotic disorders, neurocognitive disorders, neurodevelopmental disorders, or substance-related and addictive disorders\n* Presence of significant psychotic symptoms, such as delusions or hallucinations\n* Severe or unstable diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidneys, endocrine system, hematologic system, or other systems that, in the investigator's judgment, make the participant unsuitable for the study\n* Evident suicide risk, defined as a score of 1 or higher on the suicide item of the 17-Item Hamilton Depression Rating Scale\n* Active inflammatory disease\n* Gastrointestinal infection, tumor, or other organic digestive disease, including but not limited to irritable bowel syndrome, Crohn disease, ulcerative colitis, or celiac disease\n* History of major gastrointestinal surgery\n* Use of antibiotics, probiotics, prebiotics, or related functional products within 1 month before study entry\n* Allergy to the study product or any of its components\n* Pregnant or breastfeeding women\n* Unable or unwilling to take the study product as required by the protocol\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study",{"count":331,"type":23},88,[58],"The goal of this clinical trial is to learn if Bifidobacterium PB-18 can treat mild to moderate depressive disorder in adults aged 18 to 65 years who are not taking antidepressants or other psychotropic medications during the study. It will also learn about the safety of Bifidobacterium PB-18 and explore its potential effects on the gut-brain axis. The main questions it aims to answer are:\n\nDoes Bifidobacterium PB-18 increase the response rate at Week 8, defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17)?\n\nWhat adverse events occur in participants receiving Bifidobacterium PB-18?\n\nHow do gut microbiota, metabolite profiles, and related biological markers change after treatment with Bifidobacterium PB-18?\n\nResearchers will compare Bifidobacterium PB-18 with a placebo, a look-alike powder that does not contain PB-18, to see if Bifidobacterium PB-18 improves depressive symptoms.\n\nParticipants will:\n\nBe randomly assigned to receive Bifidobacterium PB-18 or placebo in a 1:1 ratio Take the assigned study product once daily for 8 weeks Visit the study site at baseline, Week 4, and Week 8 for symptom and safety assessments Complete study questionnaires, including HAMD-17, HAMA, PSQI, and CBCT Provide blood and stool samples at baseline and Week 8 for exploratory biological analyses",[29],[336,337,92,338,339,340,341],"Bifidobacterium PB-18","Probiotic","Gut-Brain Axis","Placebo-Controlled","Randomized","Double-Blind","2026-05-01",{"date":344,"type":35},"2026-05-07",{"date":314,"type":23},{"date":347,"type":23},"2027-04-30",{"name":349,"class":42},"First Affiliated Hospital of Zhejiang University",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":53,"enrollmentInfo":357,"targetDuration":4,"studyType":56,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":364,"leadSponsor":366,"locationsCount":78},"100632330","phase-2-mindfulness-engaged-neurostimulation-for-depression-mend-ii-100632330","NCT07512284","Mindfulness Engaged Neurostimulation for Depression (MEND II)","Mindfulness Engaged Neurostimulation for Depression","Inclusion Criteria:\n\n* Diagnosis of major depressive episode (MDE, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder.\n* At least one failed antidepressant medication trial at level 3 in the Antidepressant -Treatment History Form: Short Form (ATHF-SF) classification.\n* Montgomery-Åsberg Depression Rating Scale (MADRS) Score \\>19 (moderate - severe depression).\n* No increase or initiation of new antidepressant therapy in the four weeks prior to screening.\n* Demonstrated capacity to give informed consent.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Medically unstable patients.\n* Concomitant neurological disorder or a history of a seizure disorder.\n* Exhibiting current suicidal behavior rating on the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Patients who are pregnant or breastfeeding.\n* Any psychotic disorder or current active psychotic symptoms.\n* Patients who have intracranial implants, other medical device or condition deemed unsafe for TMS.\n* Contraindication to MRI scanning.",{"count":113,"type":23},[147],"Repetitive Transcranial Magnetic stimulation (rTMS) is an FDA-approved therapy for treatment resistant depression (TRD) that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. But studies of rTMS alone show remission rates of \\~30%. Additionally, rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success. This study will develop a novel multimodal treatment, which combines intermittent theta burst stimulation (iTBS) - a type of rTMS with digital mindfulness training to engage brain plasticity, enhance cognition and alleviate depression symptoms in individuals with TRD.",[92,361,161,29,93],"Treatment Resistant Depression",{"date":316,"type":35},{"date":342,"type":23},{"date":365,"type":23},"2029-04-30",{"name":367,"class":42},"University of California, San Diego",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":56,"phases":377,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":393,"locationsCount":78},"100614078","stereotactic-radiotherapy-treatment-for-treatment-resistant-depression-100614078","NCT07274917","Stereotactic Radiotherapy Treatment for Treatment-resistant Depression","The Efficacy and Safety of Stereotactic Radiotherapy for Treatment-Resistant Depression: An Open-Label Exploratory Study","Inclusion Criteria:\n\n* Outpatients or inpatients aged 18 to 50 years (inclusive), regardless of gender.\n* Meet the diagnostic criteria for Major Depressive Disorder (MDD), recurrent, without psychotic features, as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n* Documented treatment-resistant depression, defined as a lack of clinically meaningful response (less than 50% improvement in depressive symptoms) to at least two adequate antidepressant trials during the current episode, as recorded by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). An adequate trial requires sufficient dosage (within the recommended therapeutic range) and duration (at least 6 weeks). The current episode must involve at least one treatment failure.\n* A Hamilton Depression Rating Scale 17-item (HAMD-17) total score of ≥ 20 at both the screening and baseline visits.\n* The subject agrees to maintain their existing baseline antidepressant therapy regimen unchanged throughout the study period.\n* The patient and their legal guardian understand and voluntarily agree to participate in this study, are capable of adhering to the treatment protocol, and provide written informed consent.\n\nExclusion Criteria:\n\n* A current or prior diagnosis of any other DSM-5 mental disorder, including but not limited to: neurodevelopmental disorders, bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, substance-related and addictive disorders, or personality disorders.\n* A past medical history or current presence of clinically significant somatic diseases, such as severe or unstable cardiovascular, respiratory, digestive, endocrine, urinary, hematological, or nervous system diseases, or benign\u002Fmalignant tumors; or any condition deemed by the investigator to pose a potential risk to patient safety or their ability to fully participate in the study.\n* Any severe neurological disease or impairment, including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, cerebral infarction, intracranial hemorrhage, history of epileptic seizures or family history of epilepsy (except for those induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's disease, multiple sclerosis, or a history of severe head trauma with loss of consciousness; or any condition deemed by the investigator to pose a potential risk to patient safety or their ability to fully participate in the study.\n* Assessed by the investigator as being at significant risk of suicide, evidenced by: a \"Yes\" response to Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) in the \"Suicidal Ideation\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 6 months; OR a \"Yes\" response to any item in the \"Suicidal Behavior\" section of the C-SSRS (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) within the past 6 months; OR a score of ≥5 on Item 10 (Suicidal Thoughts) of the Montgomery-Åsberg Depression Rating Scale (MADRS).\n* Participation in other systematic neuromodulation therapies (e.g., MECT, rTMS, tDCS, VNS, DBS) within 3 months prior to screening, or participation in an interventional clinical trial within 1 month prior to screening.\n* Patients who have been non-responsive to a systematic course of MECT treatment.\n* Patients with a history of other psychosurgical procedures (including radiofrequency ablation, focused ultrasound, etc.).\n* A history of prior radiotherapy, chemotherapy, or immunotherapy, or a history of occupational exposure to radiation\u002Ftoxic substances.\n* Contraindications to Magnetic Resonance Imaging (MRI), including but not limited to: intracranial or bodily metallic implants, implanted pacemakers or cochlear implants, or claustrophobia.\n* Pregnant or lactating women.\n* Subjects of either gender who plan to become pregnant within the next 6 months or are unwilling to use effective contraception.\n* Subjects with a body weight exceeding 150 kg.\n* Any other condition considered by the investigator to make the subject unsuitable for participation in this study.","50 Years",{"count":43,"type":23},[58],"This study is an clinical trial aimed at evaluating the effectiveness and safety of stereotactic radiotherapy for treatment-resistant depression",[380,29],"Treatment-Resistant Depression",[382,383,384,385,386],"Treatment-Resistant depression","X-ray","subgenual anterior cingulate cortex","ZAP-X","stereotactic radiotherapy","2026-04-22",{"date":389,"type":35},"2026-04-27",{"date":391,"type":35},"2026-01-26",{"date":295,"type":23},{"name":394,"class":42},"Capital Medical University",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":53,"enrollmentInfo":402,"targetDuration":4,"studyType":56,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":78},"100628166","the-step-mied-trial-digital-stepped-care-for-emotional-disorders-100628166","NCT07458100","The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders","Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age: 18-65 years.\n2. Diagnosed with an emotional disorder by a outpatient psychiatrist, including depressive disorders, anxiety disorders (e.g., generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder), obsessive-compulsive disorder, post-traumatic stress disorder, and eating disorders (e.g., anorexia nervosa, bulimia nervosa).\n3. Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8.\n\nExclusion Criteria:\n\n1. Current diagnosis of psychotic disorders or bipolar disorder.\n2. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders.\n3. Current suicide risk (PHQ-9 item 9 score \\>2).\n4. Antisocial personality disorder.\n5. Severe medical illnesses that may affect intervention participation or require recent hospitalization.\n6. Previous participation in a systematic 8-week mindfulness course.\n7. Inability to access the internet.",{"count":403,"type":23},464,[58],"The goal of this clinical trial is to evaluate the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are:\n\n* Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years?\n* Is this combined approach more cost-effective than usual care alone? Researchers will compare the group receiving the digital mindfulness intervention plus their usual treatment to the group receiving only their usual treatment to see if the intervention leads to better long-term recovery and represents good value for money.\n\nParticipants in the intervention group will:\n\n* Attend eight weekly 2-hour online group mindfulness sessions.\n* Use a WeChat mini-program for 49 days of guided mindfulness exercises and daily tasks.\n* Patients who have not achieved reliable recovery after group retraining voluntarily participate in individual UP\\&MIED counseling.\n* Complete regular questionnaires and interviews over two years to track their progress.\n\nAll participants will continue to receive their usual medical care from their doctors throughout the study.",[61,29,192,407,408,409],"Obsessive-Compulsive Disorder","Post-Traumatic Stress Disorder, PTSD","Eating Disorders",[411,241,412,413,414,61],"Cost-effectiveness","Recovery","randomized controlled trial","stepped-care","2026-04-18",{"date":417,"type":35},"2026-04-21",{"date":419,"type":35},"2026-03-23",{"date":421,"type":23},"2028-05",{"name":423,"class":42},"Peking University",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":18,"sex":431,"minAge":185,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":56,"phases":435,"briefSummary":436,"conditions":437,"keywords":443,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":451,"locationsCount":453},"100480983","cognitive-behavioral-therapy-and-exercise-training-in-adolescents-at-risk-for-type-2-diabetes-100480983","NCT05543083","Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes","CBTeX","Inclusion Criteria:\n\n* Female\n* Age 12-17 years\n* Body Mass Index (BMI)\\>= 85 for age and sex\n* Type 2 Diabetes (T2D) first-or second-degree relative\n* Center for Epidemiologic Studies Depression Scale (CES-D) total score \\>=21\n\nExclusion Criteria:\n\n* T2D\u002F Type 1 Diabetes (T1D) or any major medical condition (e.g. cardiovascular, renal) that would prohibit the ability to participate in exercise training\n* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) conduct disorder, substance abuse\u002F dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia\u002Fbulimia, \\& schizophrenia\n* Insulin sensitizers, weight loss medications \\& chronic steroids\n* Structured weight loss treatment or bariatric surgery\n* Pregnancy, nursing","FEMALE","17 Years",{"count":434,"type":23},300,[58],"The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.",[438,92,29,28,439,440,441,442],"Insulin Resistance","Mental Disorder in Adolescence","Hyperinsulinism","Glucose Metabolism Disorders","Metabolic Disease",[444,445],"Adolescent Type 2 Diabetes Prevention","Exercise Training","2026-04-17",{"date":387,"type":35},{"date":449,"type":35},"2023-06-02",{"date":39,"type":23},{"name":452,"class":42},"Colorado State University",2,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":19,"minAge":185,"maxAge":432,"enrollmentInfo":461,"targetDuration":4,"studyType":56,"phases":463,"briefSummary":464,"conditions":465,"keywords":468,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":453},"100621371","enhancing-brain-and-mental-health-through-breathing-practice-100621371","NCT07369752","Enhancing Brain And Mental Health Through Breathing Practice","Enhancing Brain And Mental Health Through Breathing Practice: Clinical Applications In Rural Adolescents With Psychiatric Symptoms (Breathing Study -Adolescent)","Inclusion Criteria:\n\n* Adolescents between the ages of 12 and 17 who have been diagnosed with a major depressive disorder (mild or moderate) and\u002For an anxiety disorder.\n* Participants may have co-occurring mild to moderate alcohol or drug use problems, provided these do not require immediate specialized treatment or crisis intervention.\n* All participants must be receiving care at one of two participating MCHS outpatient psychiatry clinics and may reside in rural area (RUCA code 4-10) or non-rural area.\n* Participants must be able to read and understand English, and both parental or guardian consent and adolescent assent will be required.\n\nExclusion Criteria:\n\n* Current suicidal ideation or self-harm behavior requiring immediate clinical intervention\n* Presence of severe psychiatric comorbidities such as psychosis, bipolar disorder, depression with psychotic features, severe alcohol and drug use, or eating disorders.\n* Participants with significant cognitive impairment that would interfere with study participation.",{"count":462,"type":23},40,[58],"The purpose of this study is to evaluate the feasibility of a structured breathing intervention in rural and non-rural adolescents diagnosed with anxiety and depression, recruited from outpatient pediatric and child\u002Fadolescent psychiatry clinics.",[29,466,467],"Anxiety","Adolescent",[469,470],"Seokmun Hoheup","breathing","2026-04-02",{"date":473,"type":35},"2026-04-03",{"date":475,"type":35},"2026-02-19",{"date":477,"type":23},"2027-01",{"name":479,"class":42},"Mayo Clinic",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":19,"minAge":375,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":56,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":78},"100510352","brain-changes-during-social-reward-psychotherapy-for-mid--and-late-life-suicidality-100510352","NCT05925322","Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality","Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality: A Precision Imaging Trial","Inclusion Criteria:\n\n* Ages aged 50-80 \\[stratified so that 50% are older than 65\\]\n* Endorsement of Suicidal Ideation \\[Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID-5) Suicide Item (Item 9) with a score of 2\n* Major Depressive Disorder as determined by the SCID-5\n* Depression Rating Scale \\[Montgomery-Åsberg Depression Rating Scale (MADRS)\\] score of 16 or greater.\n* Mini Mental Status Exam (MMSE) equal or greater than a score of 23\n* Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.\n* Capacity to provide consent for research assessment and treatment.\n\nExclusion Criteria:\n\n* Intent or plan to attempt suicide in the near future.\n* History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.\n* Use of psychotropic drugs or cholinesterase inhibitors other than use of 0.5 mg or less of lorazepam daily up to seven times per week.\n* Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).\n* Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.\n* Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.","80 Years",{"count":489,"type":23},128,[58],"The investigators hypothesized that during the 9-week course of Engage \\& Connect treatment there will be an increase in brain functions of the Positive Valence System which in turn will lead to reduction in suicidality.",[92,312,161,29],[494,495,496,497,498],"Late Life Depression","Psychotherapy","Mechanisms of Action","Positive Valence System","Social Reward","2026-03-25",{"date":501,"type":35},"2026-03-27",{"date":503,"type":35},"2023-09-18",{"date":505,"type":23},"2028-09-30",{"name":507,"class":42},"Weill Medical College of Cornell University",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":56,"phases":518,"briefSummary":519,"conditions":520,"keywords":521,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":78},"100521692","phase-2-a-randomized-neuroimaging-trial-of-psilocybin-in-depression-100521692","NCT06072898","A Randomized Neuroimaging Trial of Psilocybin in Depression","Engaging Mood Brain Circuits With Psilocybin: a Randomized Neuroimaging Trial in Depression","EMBRACE","Inclusion Criteria:\n\n* Able and voluntarily willing to provide written informed consent at the screening visit\n* Over 18 and under 65 years old\n* Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits\n* Must have a responsible individual\u002Fcaregiver who is able to monitor the participant at home for 24 hours after each treatment visit in the study\n* Must have a psychiatrist and\u002For general practitioner who is able to provide psychiatric follow-up care\n* Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, recurrent or single episode without psychotic features where the duration of the current episode is at least 3 months\n* Depression of at least moderate severity as defined by a Hamilton Depression Rating Scale (HAMD-17) score \\>17\n\nExclusion Criteria:\n\n* Current or past history of bipolar I\u002FII disorder, schizophrenia, schizoaffective disorder, psychotic disorder, or delusional disorder as assessed by a structured clinical interview (MINI)\n* A clinical diagnosis of antisocial personality disorder and\u002For paranoid personality disorder (defined as meeting DSM-5 criteria) based on clinical interview and the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at a clinical interview by a psychiatrist.\n* An active clinical diagnosis of borderline personality disorder as confirmed by the MINI 7.0.\n* Depression secondary to other medical conditions or bipolar I and II disorder\n* Family history of a first degree relative with a diagnosis of schizophrenia or a primary psychotic disorder and\u002For bipolar disorder\n* Any symptoms consistent with psychosis\n* Any symptoms consistent with hypomania and\u002For mania as assessed by a psychiatrist\n* Personal history of ≥ 1 suicide attempt in the past year requiring hospitalization, defined using the Columbia Suicide Severity Rating Scale (CSSRS) (Q6 (past year) = \"y\") and clinical interview with a psychiatrist\n* Other personal circumstances or behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n* Women who are pregnant (self-report or via urine test), nursing, or planning a pregnancy\n* Lifetime history of substance use disorder with a hallucinogen\n* Lifetime history of substance-induced psychosis\n* Positive urine drug screen for illicit drugs or drugs of abuse at screening, a week prior to treatment, and during the trial (any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion)\n* Abnormal and clinically significant results on a physical examination performed within one month of study participation by a general practitioner, vital signs, ECG, or laboratory test at screening\n* QTc prolongation on ECG\n* Uncontrolled or insulin-dependent diabetes\n* History of seizure disorder except for seizures from electroconvulsive therapy and\u002For febrile seizures in childhood\n* Diagnosis of any mild or major neurocognitive disorder meeting DSM-5 criteria and based on clinical interview\u002Fcognitive screening by a psychiatrist\n* History of stroke, recent myocardial infarction (\\\u003C 1 year from signing of ICF), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF\n* Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he\u002Fshe takes part in the study\n* Exposure to psilocybin or any other psychedelic in the past 12 months prior to screening and\u002For during the current MDE and use of psychedelics, such as ayahuasca\u002FLSD, during the current depressive episode\n* History of substance use and\u002For alcohol use disorder, of moderate severity or greater, in the past 12 months\n* Current enrolment in an interventional study for depression or participation in such within 30 days of screening\n* Serial blood counts to achieve a value to meet eligibility - abnormalities in screening\u002Fbaseline blood work (complete blood counts, electrolyte panel, etc.) will be reviewed by MD, then repeated serially until abnormalities resolve.","64 Years",{"count":145,"type":23},[147],"The goal of this neuroimaging clinical trial is to test whether psilocybin produces significant immediate changes in functional brain activity in networks associated with mood regulation and depression compared to placebo in patients with depression. The trial aims to determine if psilocybin:\n\n1. Changes connectivity within brain networks associated with mood and depression\n2. Changes blood flow in brain regions associated with mood and depression\n\nParticipants will be attend two treatment sessions where they receive an oral medication and supportive psychotherapy. At each session, participants will undergo an MRI scan after drug administration but prior to psychotherapy. Participants will be randomly to assigned to one of two groups that will receive, 1) microcrystalline cellulose (25mg) at the first visit and psilocybin (25mg) at the second visit, or 2) psilocybin (25mg) at both visits, respectively. Differences between groups will be compared to understand what effects on brain activity are specific to psilocybin.",[29,161],[522,523,524,92,495,525],"Psilocybin","Neuroimaging","MRI","Psychedelic","2026-03-24",{"date":528,"type":35},"2026-03-30",{"date":530,"type":35},"2025-05-28",{"date":532,"type":23},"2029-05",{"name":534,"class":42},"Sunnybrook Health Sciences Centre",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":18,"sex":19,"minAge":542,"maxAge":53,"enrollmentInfo":543,"targetDuration":4,"studyType":56,"phases":545,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":78},"100585149","phase-1-psilocybe-cubensis-mushrooms-with-or-without-fluoxetine-for-refractory-depression-100585149","NCT06898606","Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression","COGUNILA","Inclusion Criteria Age: ≥25 and \\\u003C65 years. Diagnosis: Current Major Depressive Disorder (MDD), moderate to severe, per DSM-5-TR, confirmed with SCID-5.\n\nBaseline severity: MADRS ≥20 at baseline (reassessed at the pre-dose visit to confirm ongoing eligibility).\n\nPartial Response in the current episode (PRD): ≥1 adequate antidepressant trial in this episode (therapeutic dose for ≥6-12 weeks, adherence ≥80%) with \\\u003C50% symptom reduction or clinically significant residual symptoms.\n\nClinical stability and ability to provide informed consent; willingness to comply with all study procedures (preparation, dosing session, integration, and follow-ups).\n\nContraception: For participants with reproductive potential, negative pregnancy test and agreement to use effective contraception during the study.\n\nExclusion Criteria Psychiatric disorders: Bipolar I\u002FII disorder, any psychotic disorder, or current MDD with psychotic features; first-degree family history of psychotic or bipolar disorder.\n\nSuicide risk: Acute suicidal risk, e.g., active suicidal ideation with intent or plan, recent attempt, or clinical judgment requiring urgent intervention.\n\nInteracting medications: Current use of serotonergic antidepressants (SSRI\u002FSNRI\u002FMAOI, clomipramine) or other pro-serotonergic agents (e.g., triptans, linezolid, lithium, tramadol, dextromethorphan) that cannot be discontinued per protocol-defined washout.\n\nOther psychotropics: Unstable doses of antipsychotics, mood stabilizers, or long-acting benzodiazepines within the last 2 weeks; need for medications that would compromise blinding on the dosing day.\n\nPsychotherapy changes: Initiation or major change in psychotherapy within 2 weeks prior to baseline (to preserve clinical stability).\n\nMedical conditions: Clinically significant or unstable medical illness (cardiovascular, neurological, hepatic, renal), prolonged QTc, known hypersensitivity\u002Fcontraindication to fluoxetine or study materials.\n\nPregnancy or breastfeeding. Substance use: Current substance use disorder (excluding nicotine\u002Fcaffeine) within the past 3 months; non-medical cannabis use that cannot meet the pre-dose abstinence window (e.g., ≥72 h).\n\nAny condition that, in the investigator's opinion, would make participation unsafe or interfere with the assessments.\n\nWashout note (to include in Procedures\u002FEligibility):\n\nSSRIs\u002FSNRIs: 7 days or ≥5 half-lives; prior fluoxetine: ≥6 weeks; MAOIs: ≥14 days before randomization\u002Fdosing. Participants must be willing and able to follow the washout schedule.","25 Years",{"count":544,"type":23},24,[546,147],"PHASE1","This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a psychedelic-assisted psychotherapy session in adults with treatment-resistant major depressive disorder (TRD). Eligible participants (ages 25-64) have DSM-5-TR MDD, moderate-severe, MADRS ≥20, and partial response in the current episode (≥1 adequate antidepressant trial of 6-12 weeks with \\\u003C50% symptom reduction). All participants receive one dosing session with 3g of standardized Psilocybe mushrooms - with batch assay (e.g., LC-MS) to determine the amount of psilocybin and psilocin present in the sample - with manualized preparation and integration. Participants are randomized 1:1 to fluoxetine 20 mg\u002Fday or matching placebo for 4 weeks, started 2 weeks before the psychedelic session and continued 2 weeks after. Masking is quadruple (participant, care provider, investigator, outcomes assessor). The primary outcome is change in MADRS from Baseline to Week 4, assessed by a remote, blinded rater. Key secondary outcomes include response (≥50% MADRS reduction) and remission (MADRS ≤10) at Week 4, and durability at Week 6. Exploratory outcomes assess the psychedelic experience (5D-ASC, SOCQ), psychological flexibility (AAQ-10), and safety\u002Ftolerability (UKU and adverse events). Findings will be interpreted as estimates with 95% confidence intervals to inform the design of a subsequent confirmatory trial.",[29],[522,92,550,551,552],"Fluoxetine","Treatment","Psychedelics",{"date":501,"type":35},{"date":555,"type":35},"2024-09-05",{"date":557,"type":23},"2026-11-20",{"name":559,"class":42},"Federal University of Latin American Integration",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":18,"sex":19,"minAge":185,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":56,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":453},"100607656","intervention-effect-of-temporal-interference-stimulation-tis-on-depressive-disorder-100607656","NCT07191392","Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder","Inclusion Criteria:\n\n* the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD\\>17, BSS\\>6, PHQ-15\\>5.\n* the age ranged from 18 to 65 years old, and the length of education was more than 5 years.\n* the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.\n\nExclusion Criteria:\n\n* accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.\n* accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.\n* accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective","60 Years",{"count":568,"type":23},60,[58],"To investigate the effect of Temporal Interference Stimulation (TIS) on associative memory (AM) in patients with depressive disorder",[29,572],"Temporal Interference Stimulation","2026-03-09",{"date":575,"type":35},"2026-03-10",{"date":577,"type":35},"2025-09-01",{"date":579,"type":23},"2026-06",{"name":581,"class":42},"The Second Hospital of Anhui Medical University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":19,"minAge":52,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":56,"phases":591,"briefSummary":592,"conditions":593,"keywords":598,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":78},"100623481","act-for-veterans-with-ibd-and-mental-health-challenges-100623481","NCT07397195","ACT for Veterans With IBD and Mental Health Challenges","Using Acceptance and Commitment Training to Promote Rehabilitation and Engagement in Values-Centered Living in Veterans Adapting to Inflammatory Bowel Disease and Mental Health Challenges (RECLAIM)","RECLAIM","Inclusion Criteria:\n\n* Diagnosis of IBD as confirmed by the medical record\n* Current diagnosis of a depressive, anxiety, or trauma-related disorder\n\nExclusion Criteria:\n\n* Severe IBD symptoms that would prevent full participation in the study (i.e., hospitalized in the past 30 days, surgery in the past 30 days)\n* Significant cognitive impairment\n* Active suicidality\n* Uncontrolled psychosis or bipolar disorder",{"count":145,"type":23},[58],"Many Veterans with gastrointestinal disorders, such as inflammatory bowel disease (IBD), also have mental health conditions. IBD and mental health conditions can worsen one another through the brain-gut axis, leading to dramatic deficits in psychosocial functioning and quality of life (QOL). Yet, few Veterans with comorbid IBD and mental health conditions receive psychotherapy and no evidence-based psychotherapies have been tested in Veterans with these comorbidities. Adapting brief acceptance and commitment therapy (ACT) to the specific to the needs of these patients and embedding treatment into routine gastroenterology care may increase Veterans' access to efficient and effective rehabilitative care. This study aims to adapt and test an integrated, 1-Day ACT intervention tailored to the specific needs of Veterans with IBD and mental health conditions to improve psychosocial functioning and QOL.",[594,595,596,29,268,597],"Inflammatory Bowel Diseases","Crohn's Disease","Ulcerative Colitis","Stress Disorders, Post-Traumatic",[599,600,594,192,29,597],"Acceptance and Commitment Therapy","Veterans","2026-02-02",{"date":603,"type":35},"2026-02-09",{"date":605,"type":23},"2028-01-01",{"date":607,"type":23},"2032-06-30",{"name":609,"class":610},"VA Office of Research and Development","FED",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":18,"sex":19,"minAge":52,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":619,"conditions":620,"keywords":622,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":78},"100612349","gut-microbiota-in-ibd-with-comorbid-depressive-disorder-100612349","NCT07252427","Gut Microbiota in IBD With Comorbid Depressive Disorder","Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder","Inclusion Criteria:\n\nIBD with Depressive Disorder Group:\n\n1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).\n2. History of depressive disorder diagnosis or previous use of antidepressant medications.\n3. Age ≥ 18 years.\n4. Willingness to participate and provision of written informed consent.\n\nIBD without Depressive Disorder Group:\n\n1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).\n2. No history of depressive disorder diagnosis\n3. No previous use of antidepressant medications.\n4. Age ≥ 18 years.\n5. Willingness to participate and provision of written informed consent.\n\nControl Group:\n\n1. No history of inflammatory bowel disease, depressive disorder, or use of antidepressant medications.\n2. No gastrointestinal symptoms (e.g., diarrhea, constipation, abdominal pain) within the past 3 months, and no history of gastrointestinal diseases.\n3. Age ≥ 18 years.\n4. Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).\n2. Use of antibiotics or probiotic supplements within the past 6 months.\n3. Inability or difficulty in providing biological samples.\n4. Missing essential patient information.",{"count":113,"type":23},"Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited.\n\nThis study aims to investigate the diversity changes in the gut microbiome and metabolome of patients with comorbid IBD and depressive disorder through multi-omics approaches, to identify specific microbial and metabolic signatures associated with the comorbidity of these two conditions, and to provide a molecular basis for elucidating the underlying mechanisms.",[621,29],"Inflammatory Bowel Disease",[621,29,623,624,625],"Comorbidity","Gut Microbiome","Metabolomics","2026-01-22",{"date":628,"type":35},"2026-01-23",{"date":630,"type":35},"2025-03-16",{"date":632,"type":23},"2027-11-30",{"name":634,"class":42},"Fang Tang",{"id":636,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":637,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":639,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":643,"leadSponsor":645,"locationsCount":43},"100547441",{"count":638,"type":23},900,[28,29,30],"2026-01-20",{"date":626,"type":35},{"date":37,"type":35},{"date":644,"type":23},"2026-03-31",{"name":41,"class":42},{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":18,"sex":19,"minAge":52,"maxAge":566,"enrollmentInfo":653,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":655,"conditions":656,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":78},"100616903","validation-of-the-accuracy-of-an-ai-based-system-for-diagnosing-depressive-disorders-100616903","NCT07311668","Validation of the Accuracy of an AI-Based System for Diagnosing Depressive Disorders","Accuracy of an Artificial Intelligence-Based System for Diagnosing Depressive Disorders: A Paired Comparison With Psychiatrist Clinical Diagnoses","1. Subjects with anxiety disorders （1）Inclusion Criteria:\n\n   * In accordance with ICD-11 for Depressive Disorders;\n   * Between the ages of 18-60;\n   * Ability to use computers or smartphone;\n   * Native Chinese speaker;\n   * Signing informed consent. （2）Exclusion Criteria:\n   * With severe psychiatric symptoms requiring hospitalization, or unable to complete the required assessment and treatment;\n   * With a high risk of suicide or self-injury;\n   * With severe physical diseases, central nervous system diseases, or substance abuse;\n   * With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.\n2. Health Control （1）Inclusion Criteria:\n\n   * Not meet ICD-11 criteria for Mental Disorders;\n   * Between the ages of 18-60;\n   * Ability to use computers or smartphone;\n   * Native Chinese speaker;\n   * Signing informed consent. （2）Exclusion Criteria:\n   * With mental illness, or unable to complete the required assessment and treatment;\n   * With severe physical diseases, central nervous system diseases, or substance abuse;\n   * With intellectual, visual, or auditory impairments that affect their ability to interact with aided-diagnostic systems.\n3. Psychiatrist （1）Inclusion Criteria:\n\n   * Over 18 years old;\n   * A minimum of three years' experience in anxiety and other mental health fields;\n   * Intermediate or higher professional title;\n   * Currently employed in the selected test region;\n   * Signing informed consent.",{"count":654,"type":23},100,"The trial aimed to evaluate the accuracy of an artificial intelligence-based system for diagnosing depressive disorders. Specifically, it sought to determine whether the system's assessment validity is non-inferior to that of psychiatric specialists.",[29],"2025-12-29",{"date":659,"type":35},"2025-12-31",{"date":661,"type":23},"2026-02-01",{"date":663,"type":23},"2026-03-15",{"name":665,"class":42},"Shanghai Mental Health Center"]