Tests magnesium with vitamin B6 alongside usual care in first-episode bipolar disorder

Trial details

Who runs it

Mclean Hospital

Trial code

NCT05837104

Record updated

25 June 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening; Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose; Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation; Patients taking psychostimulant medication; 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; Seizure disorder; 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; Severe hypomagnesemia (serum magnesium of 0.45 mmol/L); 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; 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; Persons meeting criteria for bipolar mixed episode; Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.

ClinicalTrials.gov NCT05837104