A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Vitamin B6 Added to Usual Treatment for Adults With First Episode Bipolar I Disorder

What this Trial Is About

Researchers are evaluating the effects of Magnesium-vitamin B6 combined with standard treatment on symptoms of depression, stress, and anxiety in individuals experiencing their first episode of bipolar I disorder. This randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of this combination in the early phase of illness. It also explores changes in brain magnesium levels and energy metabolism, which are known to be altered in bipolar disorder. Participants receive either Magnesium-vitamin B6 tablets containing Magnesium citrate 100mg and Pyridoxine hydrochloride 10mg or a placebo. Both are taken three times daily for four weeks alongside usual treatment. The study includes a parallel design with randomized allocation and triple masking to ensure unbiased results. Throughout the trial, participants undergo assessments of depressive, anxiety, and stress symptoms, along with clinical evaluations using scales like the Clinical Global Impression CGI and cognitive tests. Brain energy metabolism and magnesium levels are measured by in vivo 31P magnetic resonance spectroscopy. Safety is monitored by tracking adverse events. The main outcome focuses on changes in depressive symptoms after four weeks of treatment.

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