Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
Bipolar I Disorder, Depression, Anxiety, Stress
About this trial
This is an interventional treatment trial for Bipolar I Disorder focused on measuring First episode Bipolar Disorder, Magnesium vitamin B6, Brain energy metabolism, Depression, Anxiety, Stress
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Magnesium vitamin B6
Placebo
Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
Placebo tablet will be taken three times daily for four weeks.