Clinical Trial

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

Recruiting Phase 2
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-04-28; most recent amendment 2026-06-22.
Status change: Not Yet Recruiting → Recruiting 2023-12-15
Trial Details
NCT Number NCT05837104
Lead Sponsor Mclean Hospital
Conditions Bipolar I Disorder, Depression, Anxiety, Stress
Enrollment 40 participants
Start Date 2023-12-13
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-25