RecruitingPhase 2NCT05837104

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

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder

Sponsor

Mclean Hospital

Enrollment

40 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Depression, Anxiety Stress Bipolar I 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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

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 Criteria22

Unable to sign informed consent.
Persons weighing over 350lbs.
Declines to participate.
Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.
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