drugset / Trial / NCT05837104

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

NCT05837104

Phase 2 Recruiting 40 enrolled Mclean Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 100 mg Oral
Subject Pyridoxine Unknown 10 mg Oral