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.
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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
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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