Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder (NCT05837104)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: McLean Hospital โ Belmont, Massachusetts
Age range: 18 Years to 50 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- McLean Hospital โ Belmont, Massachusetts
๐ Contact the Study Coordinator
Phone: (617) 855-2637
Email: kcuklanz@mclean.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bipolar I Disorder
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- An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania โ Little Rock, Arkansas
- Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder โ Rochester, Minnesota
- A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder โ Huntsville, Alabama
- Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder โ Belmont, Massachusetts
Explore by condition: All Bipolar I Disorder clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.