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

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 DepressionHAM-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 screeningand expected to not require addition of any new psychiatric medications during theduration 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 ofcontraception.

• 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, activewithin 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disordersnot 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 toscreening.

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

• Persons who have taken an investigational psychotropic drug within the past 6 monthsunless the investigational drug was a one-time dose.

• Seizure disorder.

• Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginkobiloba.

• Previous treatment with the following procedures: vagus nerve stimulation, or deepbrain stimulation.

• Have a history of electroconvulsive therapy (ECT) or transcranial magneticstimulation (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 orglucose-galactose malabsorption syndrome (rare hereditary diseases)

• Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochlorideor any of the other components of Magne B6

• Patients taking psychostimulant medication