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

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Treatments: Pyridoxal; Pyridoxine; Vitamin B 6

Criteria

Inclusion Criteria:

• Persons between the ages of 18 and 45

• DSM V diagnosis of bipolar I disorder, onset of illness in the last 7 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; with HAM-D total scores of 15 or lower.

• Moderate to extremely severe stress at screening, defined as a DASS-42 stress subscale score of >18

• 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 currently taking antidepressants.

• 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