Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

NCT05837104 | Recruiting Phase 2

• 1 other identifier: 2022P001911
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Depression, Anxiety; Stress; Bipolar I Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms

  Change from baseline to week 4 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.

  4 weeks

Secondary Outcomes (10)

• Change in anxiety symptoms

  4 weeks

• Change in stress symptoms

  4 weeks

• Change in Clinical Global Impression (CGI) Scale

  4 weeks

• Change in cognitive measure

  4 weeks

• Changes in brain ATP

  4 weeks

Other Outcomes (8)

• Change in World Health Organization Disability Assessment Schedule (WHODAS) score

  4 weeks

• Change in World Health Organization Quality of Life (WHOQOL) score

  4 weeks

• Change in Mg blood level

  4 weeks

Study Arms (2)

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.

Drug: Magnesium vitamin B6

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

Placebo tablet, three times daily for four weeks.

Placebo

Magnesium vitamin B6 DRUG

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

Also known as: MagnéVie B6®

Magnesium vitamin B6

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unable to sign informed consent.
• Persons weighing over 350lbs.
• Declines to participate.
• Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.
• 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.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Virginie-Anne Chouinard, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle Cuklanz, B.S.

CONTACT

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

Virginie-Anne Chouinard, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Psychotic Disorders Division

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: December 13, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)