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

NCT05837104 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

DRUG

Magnesium vitamin B6

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

DRUG

Placebo

Placebo tablet, three times daily for four weeks.

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Virginie-Anne Chouinard, M.D. · Mclean Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05837104 on ClinicalTrials.gov