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

Summary

This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.

Eligibility

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 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.

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

Conditions5

Locations1 site

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