Using Magnesium and Vitamin B6 to Treat First Episode Bipolar Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled proof-of-concept study aimed at evaluating the efficacy and safety of Magnesium-vitamin B6 in combination with standard treatment for individuals experiencing their first episode of bipolar I disorder. The study focuses on alleviating symptoms of depression, anxiety, and stress, which are common challenges following the initial episode. Participants will undergo assessments of their mood and anxiety symptoms, as well as brain energy metabolism using advanced imaging techniques. The goal is to determine if this combination can improve recovery outcomes in early-stage bipolar disorder.

Why it matters

Who can join: the full rules

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, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.
* Young Mania Rating Scale (YMRS) scores of less than 15
* Ability to sign informed consent.
* Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study.

Exclusion Criteria:

* Unable to sign informed consent.
* Persons weighing over 350lbs.
* Declines to participate.
* Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.
* 2 or more manic symptoms that meet DSM-V criteria.
* Persons of childbearing potential who are not using a medically accepted means of contraception.
* Persons who are deemed a serious suicide or homicide risk.
* Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
* The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder.
* Persons meeting criteria for bipolar mixed episode.
* Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.
* Severe hypomagnesemia (serum magnesium of 0.45 mmol/L).
* Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.
* Seizure disorder.
* Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.
* Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.
* Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months.
* Have any medical condition that would prevent blood draws.
* Have a history of significant head injury.
* Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
* Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6
* Patients taking psychostimulant medication

Where it's running

• McLean Hospital
  Belmont, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Virginie-Anne Chouinard, M.D. — Mclean Hospital
• Study coordinator: Kyle Cuklanz, B.S.
• Email: kcuklanz@mclean.harvard.edu
• Phone: 617-855-2637

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.