RecruitingPhase 2NCT05837104

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

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


Sponsor

Mclean Hospital

Enrollment

40 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of magnesium and vitamin B6 supplements can reduce depressive symptoms in people with a first episode of bipolar I disorder who are already on stable psychiatric medications. The goal is to see if this safe, affordable supplement can serve as an add-on treatment to improve mood. **You may be eligible if...** - You are between 18 and 50 years old - You have been diagnosed with bipolar I disorder within the past 10 years - You have at least two mild depressive symptoms currently - Your manic symptoms are low (YMRS score below 15) - Your psychiatric medications have been stable for at least 2 weeks and are expected to stay unchanged for the 4-week study period **You may NOT be eligible if...** - You have active or severe manic symptoms - You have been diagnosed with schizophrenia, substance use disorder (within the past 2 months), or severe personality disorder - You weigh more than 350 pounds - You have unstable heart, kidney, liver, or neurological disease - You are pregnant or not using an accepted form of contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMagnesium vitamin B6

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

DRUGPlacebo

Placebo tablet, three times daily for four weeks.


Locations(1)

McLean Hospital

Belmont, Massachusetts, United States

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NCT05837104


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