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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor

213 Previous Clinical Trials

21,654 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for participation in this study?

"This clinical trial seeks 40 individuals with a DSM V diagnosis of bipolar I disorder, who meet the following criteria: between 18 and 45 years old, less than 7 years since initial manifestation, minimum two symptoms on HAM-D (with total score 15 or lower), DASS 42 stress subscale scores over 18, YMRS under 15, willing to sign an informed consent form and no expected changes in psychiatric medications during the 4 week duration."

Answered by AI

How extensive is the patient cohort taking part in this research endeavor?

"Correct. Evidence on clinicaltrials.gov reveals that this examination, which was initially posted on December 13th 2023, is presently recruiting. Approximately 40 patients need to be enlisted from 1 medical clinic."

Answered by AI

Does the eligibility for this experiment extend to adults aged 18 or above?

"This clinical trial is accepting participants aged 18 to 45 years old."

Answered by AI

Is the current enrollment window for this research still open?

"Indeed, clinicaltrials.gov reveals that this research is actively seeking out participants. It was originally posted on December 13th 2023 and updated as recently as December 15th of the same year. Forty individuals are required for enrollment from a single medical site."

Answered by AI

Has the FDA sanctioned Magnesium vitamin B6 for use in treatment?

"Magnesium vitamin B6 is still a relatively novel medical intervention, so it received a rating of 2. This reflects the Phase 2 status of this treatment - while there are some safety data points available, efficacy has yet to be established."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Virginie-Anne Chouinard, MD 2023. "Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837104.

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