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

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