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Mineral and Vitamin Supplement

Magnesium + Vitamin B6 for Bipolar Disorder

Phase 2
Recruiting
Led By Virginie-Anne Chouinard, M.D.
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persons between the ages of 18 and 45
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; with HAM-D total scores of 15 or lower.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Summary

This trial will study if a combination of magnesium & vitamin B6 can help treat depression, stress, & anxiety in people with bipolar I disorder.

Who is the study for?
This trial is for adults aged 18-45 with a recent diagnosis of bipolar I disorder, experiencing certain symptoms like depressed mood and anxiety. They should have moderate to severe stress but not be in a manic state, as shown by specific rating scales. Participants must be stable on their current psychiatric meds with no changes expected during the study.Check my eligibility
What is being tested?
The trial is testing if adding Magnesium vitamin B6 to usual treatment helps reduce depression, stress, and anxiety in those having their first episode of bipolar I disorder. It's a randomized test where patients won't know if they're getting the actual supplement or a placebo.See study design
What are the potential side effects?
While not specified here, common side effects from supplements like Magnesium vitamin B6 could include stomach upset, diarrhea, or nausea. Since it's being tested for safety too, part of this trial will monitor participants for any unexpected reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I have at least two symptoms of depression but my overall depression is mild.
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I am experiencing high levels of stress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depressive symptoms
Secondary outcome measures
Change in Clinical Global Impression (CGI) Scale
Change in adverse events
Change in anxiety symptoms
+7 more
Other outcome measures
Change in Extrapyramidal Symptom Rating Scale (ESRS) total score
Change in Global Functioning Scale - Social and Role (GFS) total score
Change in Mg blood level
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium vitamin B6Experimental Treatment1 Intervention
Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet will be taken three times daily for four weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Bipolar Disorder, such as lithium, work through neuroprotective and neurotrophic mechanisms, enhancing neuronal plasticity and stabilizing mood by modulating neurotransmitter systems and second messenger pathways. Magnesium supports neurotransmitter function, while Vitamin B6 aids in neurotransmitter synthesis, both crucial for maintaining balanced brain chemistry. These mechanisms are vital for Bipolar Disorder patients as they help stabilize mood swings, reduce the frequency and severity of episodes, and improve overall brain health, thereby enhancing the quality of life.
An Oldie but Goodie: Lithium in the Treatment of Bipolar Disorder through Neuroprotective and Neurotrophic Mechanisms.

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,621 Total Patients Enrolled
35 Trials studying Bipolar Disorder
2,242 Patients Enrolled for Bipolar Disorder
Virginie-Anne Chouinard, M.D.Principal InvestigatorMclean Hospital
1 Previous Clinical Trials
90 Total Patients Enrolled
~27 spots leftby Dec 2025