Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Trial of Magnesium Vitamin B6 With Treatment as Usual in First Episode Bipolar I Disorder
Led by Mclean Hospital · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Magnesium-vitamin B6 combined with standard treatment on symptoms of depression, stress, and anxiety in people who have experienced their first episode of bipolar I disorder. This randomized, double-blind, placebo-controlled trial aims to understand how this combination impacts mood symptoms and brain energy metabolism, which are often altered in bipolar disorder and can affect recovery early in the illness. Participants will be randomly assigned to receive either Magnesium vitamin B6 tablets (containing Magnesium citrate 100 mg and Pyridoxine hydrochloride 10 mg) or placebo tablets. Both groups will take the tablets three times daily for four weeks, alongside their usual treatment. The study will also measure brain magnesium levels and energy metabolism using specialized magnetic resonance spectroscopy techniques. During the four-week treatment period, participants will undergo assessments of depressive, anxiety, and stress symptoms, along with cognitive evaluations and clinical global impressions. Brain imaging studies will monitor changes in brain energy markers and magnesium concentration. Safety will be closely monitored by recording any adverse events. The total study participation includes screening, treatment, and follow-up assessments over the four-week treatment duration.
CONDITIONS
Brief Title
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons between the ages of 18 and 50
- Diagnosis of bipolar I disorder with illness onset in the last 10 years
- At least two symptoms on the Hamilton Rating Scale of Depression, including depressed mood, feelings of guilt, or anxiety-related symptoms
- Young Mania Rating Scale score less than 15
- Ability to sign informed consent
- Stable disorder with no change in psychiatric medications within 2 weeks before screening and expected stability during the 4-week study period
You will not qualify if you...
- Unable to sign informed consent
- Weight over 350 pounds
- Declines to participate
- Diagnosis of bipolar NOS, cyclothymia, or schizoaffective bipolar type
- Presence of 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 including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological diseases
- Recent substance use disorders or psychiatric diagnoses including schizophrenia, delusional disorder, psychotic disorders, acute bereavement, severe borderline or antisocial personality disorder
- Bipolar mixed episode
- Exposure to levodopa, quinidine, or proton-pump inhibitors within 3 months prior to screening
- Severe hypomagnesemia
- Use of investigational psychotropic drugs within past 6 months except one-time dose
- Seizure disorder
- Use of certain dietary supplements such as SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba
- Previous vagus nerve stimulation or deep brain stimulation
- Electroconvulsive therapy or transcranial magnetic stimulation within last 3 months
- Medical conditions preventing blood draws
- History of significant head injury
- Rare hereditary diseases affecting sugar metabolism
- Allergies to magnesium citrate, pyridoxine hydrochloride, or components of Magne B6
- Use of psychostimulant medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants take either Magnesium vitamin B6 or placebo tablets three times daily in addition to their usual treatment for bipolar disorder.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
Research Team
K
Kyle Cuklanz, B.S.
V
Virginie-Anne Chouinard, M.D.
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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