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Study details
Enrolling now

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

Mclean Hospital
NCT IDNCT05837104ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

40

Study length

about 2.1 years

Ages

18–50

Locations

1 site in MA

What this study is about

Researchers are testing whether magnesium vitamin B6, combined with usual treatment, can help reduce symptoms of depression, stress, and anxiety in people experiencing their first episode of bipolar I disorder. The trial will last for 749 days.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Magnesium vitamin B6
  • 2.Take Placebo

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

Enzyme Interactions

Drug routes

oral (Oral Tablet)

Endpoints

Primary: Change in depressive symptoms

Secondary: Change in adverse events, Change in anxiety symptoms, Change in stress symptoms

Body systems

Psychiatry / Mental Health