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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
Who can join
Ages 18 to 50 · All sexes
Full eligibility criteria
Inclusion Criteria: * Persons between the ages of 18 and 50 * DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years * 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. * Young Mania Rating Scale (YMRS) scores of less than 15 * Ability to sign informed consent. * 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. Exclusion Criteria: * Unable to sign informed consent. * Persons weighing over 350lbs. * Declines to participate. * Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type. * 2 or more manic symptoms that meet DSM-V criteria. * Persons of childbearing potential who are not using a medically accepted means of contraception. * Persons who are deemed a serious suicide or homicide risk. * Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease. * 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. * Persons meeting criteria for bipolar mixed episode. * Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening. * Severe hypomagnesemia (serum magnesium of 0.45 mmol/L). * Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose. * Seizure disorder. * Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba. * Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation. * Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months. * Have any medical condition that would prevent blood draws. * Have a history of significant head injury. * Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) * Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6 * Patients taking psychostimulant medication
About the study
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.
What is being tested
- Magnesium vitamin B6 (drug)
- Placebo (drug)
Sponsor: Mclean Hospital · Participants: 40 · Started: Dec 13, 2023
Contact the study team
- Kyle Cuklanz, B.S. · Phone: 617-855-2637
- Virginie-Anne Chouinard, M.D. · Phone: 617-855-3034
Official record on ClinicalTrials.gov — NCT05837104
Locations in the U.S.
| Massachusetts | McLean Hospital, Belmont |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.