Micronutrients as Adjunctive Treatment for Bipolar Disorder

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT03541031

Run by

Eastern Maine Medical Center

People needed

120

Starts

2018-05-29

Expected to finish

2019-06-30

Last updated by the study team

2018-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participants will be excluded from the study for any of the following reasons:
• Evidence of untreated or unstable thyroid disease (until it is treated and stabilized).
• Known abnormality of mineral metabolism (e.g., Wilson's disease) until stabilized.
• Unable to speak English
• Any hypervitaminosis syndrome
• Acute suicidality (until stabilized).
• Participation in the study will not alter the participants' clinical care except that they will be provided Micronutrients and Fish oil (or placebos for each) and will participate in a monthly evaluation of the effect of adding these Micronutrients. We will ask them what other supplements they are taking and will instruct them not to take supplements that contain any of the same ingredients that they will receive in the study so as to avoid exceeding the maximum dose allowed.

Where it is running

• Eastern Maine Medical Center — Bangor, Maine, United States (enrolling)

Full record on ClinicalTrials.gov

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