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RECRUITING
NCT05837104
PHASE2

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

Sponsor: Mclean Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-12-13

Completion Date

2026-10

Last Updated

2026-01-23

Healthy Volunteers

No

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.

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States