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
Overview
- Phase
- Phase 2
- Intervention
- Magnesium vitamin B6
- Conditions
- Bipolar I Disorder
- Sponsor
- Mclean Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in depressive symptoms
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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.
Detailed Description
After a first episode of bipolar disorder, subsequent depressive and anxiety symptoms can pose a major challenge to an individual's recovery early in the illness. Individuals often have depressive and anxiety symptoms for a significant proportion of their time. These mood and anxiety symptoms are associated with higher risk for relapse, chronicity and disability. Previous studies have shown that the combination of Magnesium-vitamin B6 has beneficial effects on stress, and depressive and anxiety symptoms. This randomized, double-blind, placebo-controlled trial will assess the benefits of Magnesium-vitamin B6 in combination with treatment as usual (standard of clinical care) on depressive and anxiety symptoms and stress in individuals with bipolar disorder in the early phase of illness. In addition, the investigators aim to assess the effects of Magnesium-vitamin B6 on brain free \[Mg2+\] and energy metabolism, observed to be altered in bipolar disorder, measured by in vivo 31P magnetic resonance spectroscopy (31P MRS). Magnesium is a promising targeted intervention for bipolar disorder given its significant effects on energy metabolism.
Investigators
Virginie-Anne Chouinard, MD
Psychiatrist, Psychotic Disorders Division
Mclean Hospital
Eligibility Criteria
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.
Arms & Interventions
Magnesium vitamin B6
Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
Intervention: Magnesium vitamin B6
Placebo
Placebo tablet will be taken three times daily for four weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in depressive symptoms
Time Frame: 4 weeks
Change from baseline to week 4 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.
Secondary Outcomes
- Change in stress symptoms(4 weeks)
- Change in Clinical Global Impression (CGI) Scale(4 weeks)
- Changes in brain ATP(4 weeks)
- Changes in brain inorganic phosphate concentration(4 weeks)
- Changes in brain pH(4 weeks)
- Change in anxiety symptoms(4 weeks)
- Change in cognitive measure(4 weeks)
- Changes in brain PCr(4 weeks)
- Change in brain Mg2+ concentration(4 weeks)
- Change in adverse events(4 weeks)