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

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT05837104
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnesium vitamin B6 — DRUG
    Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
  • Placebo — DRUG
    Placebo tablet, three times daily for four weeks.

Study Details

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.

Key Dates

Start date
Dec 13, 2023
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Magnesium vitamin B6
    Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
  • Placebo Comparator: Placebo
    Placebo tablet will be taken three times daily for four weeks.

Primary Outcome Measure

Change in depressive symptoms [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Kyle Cuklanz, B.S.
[email protected]
617-855-2637
Virginie-Anne Chouinard, M.D.
[email protected]
617-855-3034
Virginie-Anne Chouinard, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Belmont, MA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
McLean Hospital· Belmont, MA

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