Magnesium and Vitamin B6 for Bipolar Disorder

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

Recruiting Phase 2 Interventional Study
Bipolar I Disorder Depression, Anxiety Stress
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mclean Hospital · Other
Who this trial is looking for

This trial is looking for adults aged 18 to 50 who have been diagnosed with bipolar I disorder within the last 10 years. Participants will take Magnesium and Vitamin B6 along with their usual treatment to help manage their symptoms of depression, stress, and anxiety over 4 weeks.

Are You a Good Fit for This Trial?
Rules you out Substance use disordersSchizophreniaBipolar mixed episodeSeizure disorderSevere hypomagnesemia

You may be able to join if

  • I am between 18 and 50 years old.
  • I have been diagnosed with bipolar I disorder within the last 10 years.
  • I have at least two specific symptoms of depression.
  • I have a Young Mania Rating Scale score of less than 15.
  • I can sign the consent form.
  • My disorder is stable, and I haven't changed my psychiatric medications in 2 weeks.

You may not be able to join if

  • I cannot sign the consent form.
  • I weigh over 350 lbs.
  • I do not want to participate.
  • I have been diagnosed with bipolar NOS, cyclothymia, or schizoaffective bipolar type.
  • I am at serious risk of suicide or homicide.
  • I have an unstable medical illness.
  • I have a history of significant head injury.
  • I have allergies to magnesium citrate or vitamin B6.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Persons between the ages of 18 and 50 * DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years * Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic…
Contacts

Kyle Cuklanz, B.S.

617-855-2637

kcuklanz@mclean.harvard.edu

CONTACT

Virginie-Anne Chouinard, M.D.

617-855-3034

vchouinard@mclean.harvard.edu

CONTACT