Recruiting
Phase 2

Magnesium Vitamin B6

Sponsor:

Mclean Hospital

Code:

NCT05837104

Conditions

Bipolar I Disorder

Depression, Anxiety

Stress

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Magnesium vitamin B6

Placebo

Study Details

Brief summary:

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.

Conditions

Bipolar I Disorder

Depression, Anxiety

Stress

Study ID

NCT05837104

Start date

Dec 13, 2023

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Magnesium vitamin B6

Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.

placebo comparator: Placebo

Placebo tablet will be taken three times daily for four weeks.

Interventions

Magnesium vitamin B6

Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.

Placebo

Placebo tablet, three times daily for four weeks.

Primary outcome measure

  • Change in depressive symptoms [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Kyle Cuklanz, B.S.

617-855-2637kcuklanz@mclean.harvard.edu

Virginie-Anne Chouinard, M.D.

617-855-3034vchouinard@mclean.harvard.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Kyle Cuklanz, B.S.

617-855-2637kcuklanz@mclean.harvard.edu

Virginie-Anne Chouinard, M.D.

617-855-3034vchouinard@mclean.harvard.edu

Principal Investigator:

Virginie-Anne Chouinard, M.D.

More Information

Sponsor

Mclean Hospital

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • First episode Bipolar Disorder
  • Magnesium vitamin B6
  • Brain energy metabolism
  • Depression
  • Anxiety
  • Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-06-25.