[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bipolar-disorder-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bipolar-disorder-depression":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100609181","time-restricted-eating-tre-in-bipolar-disorder-100609181",false,"NCT07211217","Time Restricted Eating (TRE) in Bipolar Disorder","TREBD","Inclusion Criteria:\n\n* Adults (aged 18-65 years)\n* Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21\n* Currently experiencing depression (i.e., PHQ-9 ≥ 10)22\n* Currently overweight (i.e., Body mass index (BMI) \\> 30 kg\u002Fm2)\n* Provides Informed Consent\n\nExclusion Criteria:\n\n1. Dietary factors:\n\n   1. Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)\n   2. Concurrent dietary intervention or modification unrelated to study procedures\n2. Psychiatric factors:\n\n   1. Severe depression (i.e., PHQ-9\\>20)\n   2. Experiencing manic symptoms (i.e., ASRM \\\u003C 6)23\n   3. Active suicidal ideation (i.e., PHQ-9, item 9 \\>2)\n   4. Current alcohol\u002Fsubstance use disorder (as assessed with the Quick SCID)\n3. Medical factors:\n\n   1. Use of weight loss medications or supplements\n   2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months\n   3. Previous weight loss surgery\n   4. Malignancy within past 2 years\n   5. Major surgery within past 3 months\n   6. Medical instability considered to interfere with study procedures\n   7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)\n   8. Undergoing treatment for cancer\n   9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.\n4. Lifestyle and other factors:\n\n   a. Work or social schedules that would impede ability to adhere to study protocol\n5. Adherence factors:\n\n   1. Ability to adhere to study procedures","ALL","18 Years","65 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.",[27,28,29],"Bipolar Disorder (BD)","Bipolar Disorder Depression","Overweight (BMI > 30)",[31],"Time Restricted Eating","RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-15","ACTUAL",{"date":35,"type":21},{"date":39,"type":21},"2027-09-30",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"100632204","transcranial-photobiomodulation-for-bipolar-depression-100632204","NCT07510646","Transcranial Photobiomodulation for Bipolar Depression","A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression","Inclusion Criteria:\n\n* • Diagnosis of bipolar depression\n\n  * Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher\n  * Capable of providing consent\n  * Currently inpatient or outpatient\n  * Ability to communicate in spoken and written English fluently enough to complete the required study assessments\n\nExclusion Criteria:\n\n* Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10\n\n  * Currently psychotic\n  * Judged to be at serious and imminent suicidal risk\n  * Currently has alcohol or substance use disorder (meeting criteria in the past 1 months)\n  * Unstable medical conditions\n  * Inability to consent or to complete study procedures\n  * Changes in medications or use of augmentative devices and other interventions in the 4 weeks prior to the study\n  * Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study\n  * Current pregnancy or intention to become pregnant",{"count":20,"type":21},[24],"This study the effectiveness and safety of light therapy device targeted at the brain using a wearable device, the Vielight RX Gamma as a treatment for bipolar depression. Up to forty patients with bipolar disorder will be enrolled into the study and will either receive active treatment with the Vielight RX Gamma or sham (inactive device). They will be administered the devices in clinic 5days\u002Fweek for 6 weeks. Changes in disease symptoms, cognitive function, pain, quality of life and rest EEG changes will be assessed.",[55,27,28],"Bipolar",[57,58,59,60,61,62],"photobiomodulation","PBM","Vielight","bipolar disorder","bipolar depression","light therapy","NOT_YET_RECRUITING","2026-04-01",{"date":66,"type":36},"2026-04-03",{"date":68,"type":21},"2026-07-01",{"date":70,"type":21},"2027-07-01",{"name":72,"class":73},"Vielight Inc.","INDUSTRY",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":17,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":43},"100611858","hd-tdcs-for-adolescent-bipolar-depression-targeting-s1-100611858","NCT07246044","HD-tDCS for Adolescent Bipolar Depression Targeting S1","High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial","Inclusion Criteria:\n\n* Between 12 and 18 years of age;\n* Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K- SADS-PL, patients' age\\\u003C 18 years old);\n* A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) \\\u003C12;\n* Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase;\n* Participants and 1 or 2 parents (patients' age\\\u003C 18 years old) provide informed consent after the detailed description of the study.\n\nExclusion Criteria:\n\n* Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening;\n* Comorbidity of other DSM-IV axis I disorders or personality disorders;\n* Judged clinically to be at serious suicidal risk;\n* Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;\n* Unstable medical conditions, e.g., severe asthma;\n* Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;\n* Mental retardation or autism spectrum disorder;\n* Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);\n* Contraindications to tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion);\n* Current drug\u002Falcohol abuse or dependence;\n* Pregnant or lactating female.","12 Years",{"count":83,"type":21},100,[24],"This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.",[87,88,89,90,28],"Adolescent","Bipolar Depression","tDCS","Primary Somatosensory Cortex",[92,93,61,94],"primary somatosensory cortex","adolescent","high-definition transcranial direct current stimulation","2025-11-17",{"date":97,"type":36},"2025-11-24",{"date":99,"type":36},"2025-09-16",{"date":101,"type":21},"2027-12-31",{"name":103,"class":42},"Jiangsu Province Nanjing Brain Hospital"]