[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":30,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":47,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mclean Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Magnesium vitamin B6","EXPERIMENTAL","Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.",[13],"Drug: Magnesium vitamin B6",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo tablet will be taken three times daily for four weeks.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.",[9],[26],"MagnéVie B6®",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo tablet, three times daily for four weeks.",[15],null,[32],{"name":33,"affiliation":5,"role":34},"Virginie-Anne Chouinard, M.D.","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Kyle Cuklanz, B.S.","CONTACT","617-855-2637","kcuklanz@mclean.harvard.edu",{"name":33,"role":38,"phone":42,"phoneExt":30,"email":43},"617-855-3034","vchouinard@mclean.harvard.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"McLean Hospital","RECRUITING","Belmont","Massachusetts","02478","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-71.17867,42.39593,{"lat":57,"lon":56},[60,61,62],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},{"name":33,"role":38,"phone":42,"phoneExt":30,"email":43},{"name":33,"role":34,"phone":30,"phoneExt":30,"email":30},{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Virginie-Anne Chouinard, MD","Psychiatrist, Psychotic Disorders Division","100503580","phase-2-efficacy-and-safety-of-magnesium-vitamin-b6-in-first-episode-bipolar-disorder-100503580",false,"NCT05837104","Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder","A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder","Inclusion Criteria:\n\n* Persons between the ages of 18 and 50\n* DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years\n* Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.\n* Young Mania Rating Scale (YMRS) scores of less than 15\n* Ability to sign informed consent.\n* Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study.\n\nExclusion Criteria:\n\n* Unable to sign informed consent.\n* Persons weighing over 350lbs.\n* Declines to participate.\n* Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.\n* 2 or more manic symptoms that meet DSM-V criteria.\n* Persons of childbearing potential who are not using a medically accepted means of contraception.\n* Persons who are deemed a serious suicide or homicide risk.\n* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.\n* The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder.\n* Persons meeting criteria for bipolar mixed episode.\n* Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.\n* Severe hypomagnesemia (serum magnesium of 0.45 mmol\u002FL).\n* Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.\n* Seizure disorder.\n* Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.\n* Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.\n* Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months.\n* Have any medical condition that would prevent blood draws.\n* Have a history of significant head injury.\n* Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n* Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6\n* Patients taking psychostimulant medication","ALL","18 Years","50 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.",[84,85,86],"Bipolar I Disorder","Depression, Anxiety","Stress",[88,9,89,90,91,86],"First episode Bipolar Disorder","Brain energy metabolism","Depression","Anxiety","2026-06-22",{"date":94,"type":95},"2026-06-25","ACTUAL",{"date":97,"type":95},"2023-12-13",{"date":99,"type":78},"2026-10",{"name":5,"class":6},1]