[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-depressive-diorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-depressive-diorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,70,99,136,163,195],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100614573","phase-1-rct-of-psilocybin-assisted-cbt-for-depression-100614573",false,"NCT07281352","RCT of Psilocybin-assisted CBT for Depression","Psilocybin-Assisted Cognitive Behavioral Therapy for Depression","Inclusion Criteria:\n\n* Ages 21-60,\n\n  * Able to swallow capsules,\n  * Patients with a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),\n  * Active current depressive symptoms (i.e., scores \\>16 on the Hamilton-Depression Rating Scale (HAM-D) covering the prior 2 weeks; Hamilton, 1986),\n  * Have an identified support person who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,\n  * For women of child-bearing potential - using one form of highly effective contraception (e.g., oral contraceptive pill) and willingness to continue contraceptive use for duration of study\n  * Patient has been medically cleared for the study by a physician.\n\nExclusion Criteria:\n\n* A personal or family history (first or second-degree) of psychosis or bipolar disorder\n\n  * Resting blood pressure above 140 systolic, 90 diastolic (averaged across four separate measurements)\n  * Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),\n  * Active suicidality (as indicated by a 3 or greater on item 3 of the HAM-D) or other psychiatric disturbance requiring acute treatment\n  * Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan),\n  * Currently receiving cognitive behavioral therapy,\n  * Any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition\n  * A history of stroke or Transient Ischemic Attack (TIA)\n  * Epilepsy or history of seizures\n  * Insulin-dependent diabetes\n  * Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months\n  * Positive urine drug screen for illicit substances\n  * Use of other psychedelics or ketamine within prior 12 months\n  * Adverse prior reaction to a psychedelic agent\n  * Pregnant, trying to get pregnant, or nursing","ALL","21 Years","60 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder.\n\nThis study is a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).",[28],"Major Depressive Diorder",[30,31],"psilocybin","cognitive behavioral therapy","RECRUITING","2026-02-11",{"date":35,"type":36},"2026-02-12","ACTUAL",{"date":38,"type":36},"2026-01-05",{"date":40,"type":21},"2027-11-30",{"name":42,"class":43},"University of California, Los Angeles","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100621322","phase-4-neurocircuitry-mechanisms-and-efficacy-of-lumateperone-as-adjunctive-therapy-for-major-depressive-disorder-and-history-of-early-life-abuse-100621322","NCT07369115","Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse","Intra-Cellular Therapies, Inc. \u002F \"A Randomized, Double-blind, Placebo-controlled, Single Site Study to Evaluate the Efficacy of Lumateperone for the Treatment of Major Depressive Disorder (MDD) and Early Life Trauma in Adult Patients Aged 21 to 70 Years","ITI-ELA-MDD","Inclusion Criteria:\n\n1. Provide written informed consent before the initiation of any study-specific procedures.\n\n   NOTE: Patients who are unable to independently provide informed consent will be ineligible to participate in this study.\n2. Male or female, between the ages of 21 and 70 years, inclusive;\n3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision (DSM-5-TR) criteria for Major Depressive Disorder (MDD) without psychotic symptoms, as confirmed by a trained rater using the modified Structured Clinical Interview (DIAMOND) for DSM-5,\n4. MADRS total score ≥ 22 at Screening (Visit 1) and Baseline (Visit 2)\n5. Endorse \\>=1 physical or sexual assault prior to age 16 on the interview-based trauma assessment.\n\n   Many studies refer to early life trauma as prior to age 18. Here we define early life assault as less than 16, rather than 18, in order to ensure a clearer separation between early life and adulthood. While another option might be to restrict even further (e.g., age of trauma \\\u003C 10), for feasibility (e.g., facilitating recruitment) and generalizability (e.g., results extend to MDD and early life trauma more broadly than just early childhood trauma), we decided on physical or sexual assault prior to age 16.\n\n   Regarding the focus on physical or sexual assault, there are two main reasons. First, the definition of physical and sexual assault can more easily be operationalized through a behavioral description of an event (e.g., has anyone hit you with a fist, has anyone hit you with an object, etc), enabling more precise assessment and detection. Second, there is a robustly elevated risk for mood disorders following assaultive traumas relative to non-assaultive traumas. As such, there is greater clinical need to establish adjunctive treatments among those experiencing assaultive traumas.\n6. Participants must have been treated with the same dose of antidepressant therapy for at least 6 weeks, with less than 50% improvement, and be committed to stay on the same stable dosing regimen for the Screening period and for the entire study, at or above the minimally adequate dose in the ATRQ. Documentation of stable and ongoing ADT must be verified by documentation from the subject's psychiatrist, pharmacist, primary care physician, or other qualified healthcare professional.\n7. Females of childbearing potential agree to use at least an acceptable method of birth control (including but not limited to hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from the time informed consent is provided through the end of the SFU period. NOTE: Females of non-childbearing potential (defined as either permanently sterilized, or post-menopausal females \\[defined as at least one year with no menses without an alternative medical explanation\\]) are exempt from the birth control requirement.\n8. Ability to follow study instructions and likely to complete all required visits.\n\nExclusion Criteria:\n\n1. Has a current primary DSM-5-TR psychiatric diagnosis other than Major depressive disorder. These include: PTSD, OCD, Bipolar Disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder. Intellectual disability, Dementia or other cognitive disorders. Moderate or severe substance use disorder (excluding for nicotine)\n2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his\u002Fher participation in the study or\n\n2a. At Screening (Visit 1), the patient scores \"yes\" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS within 6 months prior to Screening; or\n\n2b. At Screening (Visit 1), the patient has history of suicidal attempt(s) within 1 year prior to Screening (Visit 1); or\n\n2c. At Baseline\u002Frandomization (Visit 2), the patient scores \"yes\" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or\n\n2d. At Screening (Visit 1) or Baseline (Visit 2), scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered MADRS; or\n\n2e.Considered to be an imminent danger to himself\u002Fherself or others.\n\n3\\. MRI contraindications: History of shrapnel or other metal or electronic implants in the body(such as pacemakers, aneurysm clips, ferrous surgical devices, metallic tattoos on the head, etc.). The patient has received electroconvulsive therapy (ECT), vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the past 1 year;\n\n4\\. The patient has known hypersensitivity or intolerance to lumateperone, or to any of the excipients\n\n5\\. Treatment with a depot\u002Flong-acting injectable antipsychotic within 1 cycle before Screening (Visit 1)\n\n6\\. The following agents are excluded and must be discontinued at Screening (Visit 1):\n\n6a. Any moderate or strong cytochrome P450 3A4 inhibitor (CYP3A4), or any CYP3A4 inducer 6b. Central opioid agonists\u002Fantagonists, including tramadol 6c. Central opioid agonists\u002Fantagonists, including tramadol 6d. Dietary supplements and medical foods unless approved by the Sponsor or designee. Daily multivitamin use is permitted\n\n7\\. Monoamine oxidase inhibitors within 14 days prior to Baseline\u002FRandomization (Visit 2)\n\n8.Other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system.\n\n9\\. The patient plans to initiate psychotherapy or make changes to existing psychotherapy during the study (patients who are participating in stable psychotherapy or psychotherapy as a part of their treatment are allowed to enroll);\n\n10\\. The patient has participated in a previous clinical trial with lumateperone, or has had exposure to any investigational product within 6 months of the baseline visit or participated in \\> 2 clinical studies of an investigational product with a central nervous system indication.\n\n11\\. The patient is pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1). On Day 1 (Baseline\u002FVisit 2), female patients of childbearing potential must have a negative urine pregnancy test prior to study drug administration;\n\n12\\. The patient has a positive test for alcohol or drugs of abuse (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, or opioids\u002Fopiates) at Screening (Visit 1).\n\n13\\. The patient has abnormal laboratory values or clinical findings at Screening (Visit 1) including, but not limited to:\n\n13a. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 2 × the upper limit of normal (ULN) 13b. Total bilirubin \\> 1.0 × ULN 13c. Hemoglobin \\\u003C 8 g\u002FdL (80 g\u002FL) for females and \\\u003C 9 g\u002FdL (90 g\u002FL) for males 13d. Absolute neutrophil count (ANC) \\\u003C 1200 cells\u002FμL (1.2 × 109 cells\u002FL); 13e. Thyroid-stimulating hormone (TSH) outside of normal reference range AND free T3 or free T4 outside of the reference range. Free T3 and Free T4 will only be evaluated if TSH is outside of reference range; 13f. Poorly controlled diabetes as defined by a glycosylated hemoglobin (HbA1c) \\>7.5%, despite standard care \\[\\> 58 mmol\u002Fmol\\]; 13g. Positive test for hepatitis B surface antigen and\u002For hepatitis B core antibody immunoglobulin M at screening; positive hepatitis C antibody at Screening (Visit 1), with the exception of a patient for whom the reflex HCV RNA test is negative; 13h. Any other clinically significant abnormal laboratory result obtained at screening (Visit 1)\n\n14\\. ECG abnormalities where the patient has corrected QT interval using the Fridericia formula (QTcF) \\> 450 msec for males or \\> 470 msec for females and\u002For heart rate \\\u003C 50 bpm, or evidence of clinically significant bundle-branch blocks at Screening (Visit 1)\n\n15\\. The patient has any of the following conditions:\n\nCardiac: uncontrolled angina, or history of a myocardial infarction within 3 months prior to screening, or history of a clinically significant cardiac arrhythmia including antipsychotic drug-induced corrected QT interval prolongation, or any other cardiac disorder;\n\nMalignancy: Any diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years;\n\nGastrointestinal: history of gastric bypass or any other condition that results in malabsorption;\n\nEndocrine: hypo- or hyperthyroidism unless treated and stable with no medication changes for at least three months prior to screening, diabetes, unless considered stable with no changes in treatment for at least three months prior to screening;\n\nHepatic: Hepatitis B or Hepatitis C; moderate or severe hepatic impairment (Child-Pugh B or C);\n\nPulmonary: history of diagnosed and untreated obstructive sleep apnea;\n\nNeurological: history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or central sleep apnea, or significant brain trauma, or other cognitive disorder; History of movement disorders.\n\nInfectious: History of human immunodeficiency virus (HIV) infection.\n\nNote: Any other medical condition, or medical conditions that are stable with treatment (eg, hypertension, hypercholesterolemia, or thyroid abnormalities) are allowed as long as the condition has been stable for at least 3 months prior to Screening (Visit 1); treatments for these conditions are documented, kept stable, and are expected to be unchanged during the study; and the condition is not thought to affect safe participation in the study or relevant study outcomes in the opinion of the Investigator.\n\n16\\. The patient is judged by the Investigator to be inappropriate for the study;\n\n17\\. Patient is homeless;\n\n18\\. Patient does not speak english;","70 Years",{"count":20,"type":21},[56],"PHASE4","The purpose of this clinical research study is to understand how effective and safe an investigational study drug called lumateperone is and whether it works to reduce the severity of depressive symptoms in adults with Major Depressive Disorder (MDD) and early life trauma. The main questions it aims to answer are:\n\nAim 1: To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the treatment of patients with Major Depressive Disorder and early life abuse.\n\nAim 2: To assess neurocircuitry encoding of threat and reward learning as predictors of lumateperone response and as mechanisms of treatment action, and assess the change from pre-dose to post-dose of task-evoked brain activation.",[28,59],"Early Life Trauma","NOT_YET_RECRUITING","2026-01-23",{"date":63,"type":36},"2026-01-27",{"date":65,"type":21},"2026-02",{"date":67,"type":21},"2030-01",{"name":69,"class":43},"University of Texas at Austin",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":53,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100620814","imagery-rescripting-in-primary-care-100620814","NCT07362511","Imagery Rescripting in Primary Care","Imagery Rescripting Within Primary Care to Manage Depression: A Single-Case Experimental Design","IMPACT MADE","Inclusion Criteria:\n\n* Main complaint of depressive feelings, as indicated by both the mental health assistant and the patient.\n* HADS score for the depression subscale ≥ 11.\n* Ability to understand, read, write and speak Dutch or English.\n* Age between 18 and 70.\n* Willingness to participate in the study and treatment.\n\nExclusion Criteria:\n\n* Acute suicide risk (BDI-II-item9 score of 3).\n* If the mental health assistant suspects that the patient may have a primary diagnosis of bipolar disorder, psychosis, substance use disorder, low IQ, or if the patient suffers from serious neurological problems such as dementia, then the patient is not included. There will not be a formal assessment of a primary diagnosis.","18 Years",{"count":80,"type":21},12,[82],"NA","In the current study we aim to investigate the feasibility, acceptability, and effectiveness of ImRs offered by mental health assistants within primary care to reduce depressive symptoms. In a single-case experimental design (SCED) study, the following hypotheses will be tested:\n\n1. ImRs results in a reduction of depressive symptoms compared to baseline, and this reduction lasts up to six months.\n2. Patients with complaints of depressive symptoms find ImRs an acceptable form of intervention when offered by mental health assistants within a general practice setting.\n\nParticipants will wait for 2-4 weeks and then receive 5 sessions of ImRs over a period of 10 weeks. During these sessions, negative memories related to their depressed feelings are rescripted.",[28,85,86],"Low Self-Esteem","Mood Disorders",[88,89,90],"Imagery Rescripting","Depression","Primary care","2026-01-14",{"date":61,"type":36},{"date":94,"type":36},"2025-12-01",{"date":96,"type":21},"2027-01-31",{"name":98,"class":43},"University of Amsterdam",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":107,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":44},"100565403","creating-a-global-research-database-that-connects-genetic-information-and-long-term-health-data-to-improve-personalized-treatment-for-people-with-serious-mental-illness-100565403","NCT06641726","Creating a Global Research Database That Connects Genetic Information and Long-term Health Data to Improve Personalized Treatment for People With Serious Mental Illness","Developing an Internationally-diverse, Linked Genomic and Longitudinal Phenotypic Research Dataset to Accelerate Precision Psychiatry for Patients With Serious Mental Illness","GlobalMinds","Inclusion Criteria:\n\n\\- All participants must have an electronic health record in a primary or secondary care service.\n\nMental Health cohort(s) • Have received a diagnosis and\u002For treatment\u002Freferral for mental illness for MDD, BD, Schizophrenia.\n\n• Having an available electronic health record\n\n• Current age 18+ (no upper age limit)\n\n• Can speak English Dementia cohort\n\n• Participants aged 18+ (no upper age limit)\n\n• Currently alive and are, or have been, old age psychiatry patients\n\n•\n\nReceived relevant diagnosis or referral:\n\nEITHER\n\n• Clinical diagnosis of dementia, mild cognitive impairment (MCI) or subjective cognitive impairment (SCI) OR\n\n• Memory clinic referral\n\n• Must be willing and able to complete a validated cognitive assessment (MoCA or SLUMS).\n\nAll dementia patients will undergo the extended biomarker analysis.\n\nExclusion Criteria:\n\n\\- Mental Health cohort(s)\n\n• Patients without capacity to provide consent. Dementia cohort\n\n• Inability to understand spoken and\u002For written spoken English\n\n• Individuals with intellectual disability.\n\n• Patients with dementia in Creutzfeldt-Jakob disease (CJD), Huntington's, HIV dementia, alcohol-related dementia, intellectual disability, traumatic brain injury at any time.\n\n• Patients diagnosed with depression (only an exclusion criterion for MCI\u002FSCI patients), psychosis, bipolar disorder prior in the pre-index period - to be checked at screening.","110 Years",{"count":109,"type":21},50000,"14 Days","OBSERVATIONAL","This observational study aims to provide new insights into the nature and classification of severe mental illness and dementias that in time should help improve diagnostic practise, and enable the development of new and improved treatments. The investigators will achieve aims by gathering information and biological samples from over 50,000 research participants and then linking this information with participants' electronic health records, genetic and other potential markers of mental illnesses (called biomarkers, derived from biological samples). The investigators will use this resource to analyse how potential risk factors - genetic, other biological and non-biological (related to the participants' life circumstances) - influence participants' experiences, symptoms, and outcomes (both mental and physical health). The investigators will also use advanced analysis to assess whether there may be better ways of grouping together and understanding the experiences of those with severe mental illnesses and dementias. Given the value and importance of this resource for advancing mental health research, the investigators will also make the data available to other researchers to pursue these broad research aims.",[114,115,28,116],"Bipolar Disorder (BD)","Schizophrenia Disorders","Dementia",[118,119,120,121,122,123,124,125],"cross-sectional","observational","bioresource","biomarkers","whole genome sequencing","linked bioresource","dementia","neuropsychiatric","2025-09-30",{"date":128,"type":36},"2025-10-03",{"date":130,"type":36},"2025-05-16",{"date":132,"type":21},"2035-07-01",{"name":134,"class":135},"Akrivia Health","INDUSTRY",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100572055","efficacy-and-safety-of-dtms-in-adolescent-major-depressive-disorder-100572055","NCT06728280","Efficacy and Safety of DTMS in Adolescent Major Depressive Disorder","Efficacy and Safety of Deep Transcranial Magnetic Stimulation in Adolescent Major Depressive Disorder: a Prospective Double-Blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients of all genders, aged between 11 and 23 years old, and right-handedness.\n* In accordance with the diagnostic criteria for the major depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n* The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (M.I.N.I).\n* Beck Depression Inventory, Second Edition (BDI-II): total BDI-II score\\> 13 at screening.\n* Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.\n\nExclusion Criteria:\n\n* A diagnosis of other psychiatric disorders in the DSM-5.\n* Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the subject in completing the procedures required by the study.\n* History of significant neurologic disease, including subdural hematoma, brain tumor, unexpected seizure\u002Fepilepsy disorder, or history of significant head trauma.\n* Have obvious suicide risk, or have actual suicide behavior within 6 months before the screening.\n* History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial Direct Current Stimulation (tDCS), or transcranial Alternating Current Stimulation (tACS) treatments for any disorders.\n* There are contraindications to magnetic resonance imaging (MRI) scanning or TMS treatment, such as metal or electronic instruments.\n* Participation in any investigational drug trial within 6 months before the baseline visit.\n* Other conditions that are not suitable for the study object in the researcher's judgment.","11 Years","23 Years",{"count":146,"type":21},100,[82],"The goal of this randomized controlled trial is to explore the efficacy and safety of two different dTMS devices in adolescent depression: deep TMS H1 coil and deep TMS H7 coil.\n\nThe main questions it aims to answer are:\n\nType of study: Clinical trial. Participant population: Adolescents with major depressive disorder (MDD). Objective: To explore whether the H7 coil is no less effective than the H1 coil for adolescents with MDD, further providing clinicians with additional treatment options for patients.",[28],[151,28,152],"deep transcranial magnetic stimulation","adolescents","2025-03-10",{"date":155,"type":36},"2025-03-12",{"date":157,"type":36},"2024-12-31",{"date":159,"type":21},"2026-06-30",{"name":161,"class":43},"Zhifen Liu",2,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":162},"100571374","phase-1-qeeg-brain-signature-of-depression--neuromodulation-induced-recovery-100571374","NCT06719427","qEEG Brain Signature of Depression & Neuromodulation-induced Recovery","Quantitative Electroencephalography to Longitudinally Assess the Functional Brain Signature of Treatment-resistant Depression and Recovery With Therapeutic Neuromodulation","Inclusion Criteria:\n\n* A diagnosis of Depression based on Diagnostic and Statistical Manual (DSM) 5.0 criteria.\n* Receiving a neuromodulation (rTMS) treatment for depression at the HCN\n* Physically healthy\n* Age 18-80, inclusive.\n* Able to provide informed consent and comply with the study protocol.\n* Patients will not be excluded solely based on communication (i.e., non-English speaking) unless they have exclusion criteria that is the cause of the communication difficulties.\n\nExclusion Criteria:\n\n* Moderate substance use disorder or greater severity based on DSM 5.0 criteria and confirmed by a study MD on clinical assessment.\n* Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy)\n* A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and\u002For psychosis at the time of study enrollment.\n* History of seizure disorder\n* Pregnant","80 Years",{"count":146,"type":21},[24],"This study aims to explore how repetitive transcranial magnetic stimulation (rTMS), a treatment for depression, affects brain function. Depression disrupts the brain's complex network or regions that regulate cognition, emotion, and behavior. rTMS targets these disruptions to restore network function. To measure these effects, researchers will use dry quantitative EEG (qEEG), a new technology that records brain electrical activity quickly (15 minutes compared to 1 hour for traditional EEG) without the need for gel or lengthy electrode setups. This study will evaluate a novel qEEG activity developed by iMediSync (Republic of South Korea) in patients treated with neuromodulation for depression before, during, and up to 12 months after treatment to see if changes in brain activity to identify patterns associated with symptomatic improvement and relapse risk. Findings could help personalize depression treatments by predicting patient outcomes and optimizing care.",[28],[176,177,86,178,179,180,181,182,183,184,185],"Transcranial Magnetic Stimulation","Treatment-resistant Depression","Mental Disorders","Depressive Disorder","Depressive Disorder, Major","Depressive Disorder, Treatment-Resistant","qEEG","resting-state connectivity","neuromodulation","brain networks","2025-02-26",{"date":188,"type":36},"2025-03-03",{"date":190,"type":36},"2025-01-06",{"date":192,"type":21},"2028-01-01",{"name":194,"class":43},"Sunnybrook Health Sciences Centre",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":44},"100563434","stress-management-with-real-time-bio-signal-biofeedback-100563434","NCT06616116","Stress Management with Real-time Bio-signal Biofeedback","Development and Verification of Effectiveness of Biofeedback Contents for Stress Management Using Real-time Bio-signal Monitoring Device","Inclusion Criteria:\n\n* Individuals aged 15 to 59 years.\n* Patients diagnosed with mood disorders (e.g., bipolar disorder, major depressive disorder) through screening and clinician interviews, according to DSM-5.\n* Patients with accompanying anxiety symptoms.\n* Patients with stress symptoms (Perceived Stress Scale score ≥ 10)\n* Individuals able to independently complete questionnaires and communicate in Korean.\n* Individuals who voluntarily agree to participate in weekly treatment sessions.\n\nExclusion Criteria:\n\n* Patients diagnosed with major psychiatric disorders other than mood disorders (e.g., schizophrenia, substance use disorders including alcohol, obsessive-compulsive disorder).\n* Patients diagnosed with bipolar disorder who are currently experiencing acute psychotic symptoms or are in a manic state.\n* Individuals with acute suicidal ideation.\n* Individuals with co-occurring personality disorders (e.g., borderline personality disorder, antisocial personality disorder, narcissistic personality disorder).\n* Individuals who have participated in mindfulness-based cognitive therapy within the last 3 months.\n* Individuals currently receiving other non-pharmacological treatments (e.g., cognitive-behavioral therapy, psychoanalysis).\n* Individuals with neurological damage or conditions that may cause brain injury (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, significant head trauma with loss of consciousness lasting more than 5 minutes).\n* Individuals diagnosed with cardiovascular diseases (e.g., hypertension, coronary artery disease, arrhythmia).\n* Individuals with hearing impairment or tinnitus.\n* Individuals with impaired ability to understand the study's purpose or make decisions about participation (e.g., IQ \\< 70, dementia).\n* Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.","15 Years","59 Years",{"count":146,"type":21},[82],"The goal of this clinical trial is to learn if the real-time bio-signal monitoring device (Neuronicle FX2 device), combined with mindfulness-based cognitive therapy (MBCT), helps manage stress and improves symptoms of mood disorders, such as depression and anxiety. The main questions this study aims to answer are:\n\n* Does real-time bio-signal feedback mindfulness using the Neuronicle FX2 reduce perceived stress in participants with mood disorders?\n* Does it lead to improvements in depressive and anxiety symptoms?\n\nResearchers will compare participants receiving real-time biofeedback with the Neuronicle FX2 to those receiving no feedback during mindfulness sessions to see if the device enhances the effectiveness of stress management and symptom improvement.\n\nParticipants will:\n\n* Undergo mindfulness-based cognitive therapy (MBCT) once a week for 8 weeks.\n* Half of the participants will receive real-time biofeedback using the Neuronicle FX2 device during mindfulness sessions, while the other half will not be provided biofeedback.\n* Visit the clinic every week for their mindfulness sessions and assessments.\n* Wear the Neuronicle FX2 device during mindfulness exercises, which will measure brainwave activity (EEG) and heart rate variability (HRV).\n* Participate in assessments before, during, and after the program (8wks, 16wks) to evaluate their stress, depression, and anxiety levels.",[114,28],[209,210,211,212,213],"biosignal","neurofeedback","mindfulness","bipolar disorder","major depressive disorder","2024-09-24",{"date":216,"type":36},"2024-09-27",{"date":218,"type":36},"2024-06-13",{"date":220,"type":21},"2025-12-31",{"name":222,"class":43},"Seoul National University Hospital"]