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

Eligibility 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.
• * 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.
• * 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