Actively Recruiting
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
Led by Mclean Hospital · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 50 years old
- Diagnosed with bipolar I disorder with illness onset within the last 10 years
- At least two specific symptoms on the Hamilton Rating Scale of Depression including depressed mood or anxiety
- Young Mania Rating Scale score less than 15
- Able to provide informed consent
- Stable psychiatric condition with no medication changes in the 2 weeks before screening and expected stability during the 4-week study
You will not qualify if you...
- Unable to provide informed consent
- Weighing more than 350 pounds
- Declining to participate
- Diagnosed with bipolar NOS, cyclothymia, or schizoaffective bipolar type
- Having two or more manic symptoms meeting DSM-V criteria
- Persons of childbearing potential not using medically accepted contraception
- Serious suicide or homicide risk
- Unstable medical illnesses such as cardiovascular, liver, kidney, respiratory, endocrine, neurological, or blood diseases
- Current or recent substance use disorder within 2 months
- Diagnosed with schizophrenia, delusional disorder, psychotic disorders not otherwise specified, schizoaffective disorder, acute bereavement, severe borderline or antisocial personality disorder
- Meeting criteria for bipolar mixed episode
- Exposure to levodopa, quinidine, or proton-pump inhibitors within 3 months
- Severe low magnesium levels (serum magnesium 0.45 mmol/L or less)
- Use of investigational psychotropic drugs within 6 months unless a single dose
- History of seizure disorder
- Use of dietary supplements such as SAMe, St. John's Wort, DHEA, Inositol, or Ginkgo biloba
- Prior vagus nerve stimulation or deep brain stimulation
- Electroconvulsive therapy or transcranial magnetic stimulation within the last 3 months
- Medical conditions preventing blood draws
- History of significant head injury
- Hereditary diseases like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome
- Allergies to magnesium citrate anhydrous, pyridoxine hydrochloride, or components of Magne B6
- Taking psychostimulant medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
K
Kyle Cuklanz, B.S.
CONTACT
V
Virginie-Anne Chouinard, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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