NCT05837104 Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
| NCT ID | NCT05837104 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mclean Hospital |
| Condition | Bipolar I Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-12-13 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. * 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
Contact & Investigator
Virginie-Anne Chouinard, M.D.
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT05837104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Bipolar I Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05837104 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05837104 currently recruiting?
Yes, NCT05837104 is actively recruiting participants. Contact the research team at kcuklanz@mclean.harvard.edu for enrollment information.
Where is the NCT05837104 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT05837104 clinical trial?
NCT05837104 is sponsored by Mclean Hospital. The principal investigator is Virginie-Anne Chouinard, M.D. at Mclean Hospital. The trial plans to enroll 40 participants.
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