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

Prior treatment

• Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening.
• Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose.
• Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation.
• Patients taking psychostimulant medication

Other illness

• 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.
• Seizure disorder.
• 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.

Lab values

• Severe hypomagnesemia (serum magnesium of 0.45 mmol/L).
• 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

Other

• 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.
• Persons meeting criteria for bipolar mixed episode.
• Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba.

• 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.