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Micronutrient & Fish oil for Bipolar Disorder

N/A
Waitlist Available
Led By Lewis Mehl-Madrona, MD, PhD
Research Sponsored by Eastern Maine Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals enrolled will be adult outpatients with a diagnosis of bipolar disorder I or II, receiving care at the Family Medicine Center & Residency Program of Eastern Maine Medical Center in Bangor, Maine. Participants must be able to complete questionnaires and examinations and comply with protocols.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 4 months for 1 year
Awards & highlights

Study Summary

The purpose of the trial is to determine whether a 36-ingredient Micronutrient supplement (primarily vitamins and minerals) and Fish oil (omega-3 fatty acid) supplement improves nutritional status and allows lower doses of conventional medications to be effective for bipolar disorder with fewer side effects, when studied under randomized and fully blinded conditions and compared to a placebo. All participants must live in the vicinity of Bangor, Maine.

Eligible Conditions
  • Bipolar Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 4 months for 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 4 months for 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Side Effects
Secondary outcome measures
Changes in Anxiety Symptoms
Changes in Basal Metabolic Index
Changes in Blood Pressure
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Micronutrient & Fish oilExperimental Treatment1 Intervention
Fish oil capsule by mouth 3 capsules daily, remaining constant throughout the study and Micronutrient capsule by mouth beginning with a fixed schedule of 2 capsules twice daily and increasing monthly by 2 capsules twice daily up to a maximum of 16 capsules/day.
Group II: Olive oil & Safflower oilPlacebo Group1 Intervention
Safflower oil capsule by mouth 3 capsules daily, remaining constant throughout the study and Olive oil capsule by mouth beginning with a fixed schedule of 2 capsules twice daily and increasing monthly by 2 capsules twice daily up to a maximum of 16 capsules/day.

Find a Location

Who is running the clinical trial?

Eastern Maine Medical CenterLead Sponsor
6 Previous Clinical Trials
11,026 Total Patients Enrolled
Lewis Mehl-Madrona, MD, PhDPrincipal InvestigatorEastern Maine Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Micronutrients as Adjunctive Treatment for Bipolar Disorder
Lewis Mehl-Madrona, MD 2018. "Micronutrients as Adjunctive Treatment for Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03541031.
All > Bipolar Disorder
~17 spots leftby May 2025
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