Micronutrients as Adjunctive Treatment for Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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Bipolar disorder is a common neuropsychiatric illness with high rates of morbidity and mortality. Despite available medications to treat bipolar disorder, recurrence rates are high. Bipolar disorder is conventionally treated with typical or antipsychotic medications are well described and include the increased risk of acute kidney injury, cataracts, decreased cognitive function, increased risk for myocardial infarction and stroke, metabolic syndrome and type 2 diabetes mellitus, and dyslipidemia. Related to this, mortality rates are elevated among people with bipolar disorder compared to the general population. Men with the diagnosis of bipolar disorder live, on average 13.6 years less than the general population, and for women, 12.1 years less.

This RCT (randomized clinical trial) compares a 36-ingredient Micronutrient supplement and Fish oil supplement to matched double placebo in patients randomized to receive one or the other for 52 weeks. One hundred twenty (120) patients are randomized in a 3:2 ratio to Micronutrient + Fish oil or to placebo, respectively. All patients are stably medicated adult outpatients with bipolar disorder (type I or type II). Medical supervision is provided with monthly appointments. At the end of the 52 weeks, all participants will be offered the opportunity of entering a 52-week open-label extension. The primary hypothesis is that active supplementation will allow significantly more reduction of conventional medication than placebo will, without a significant increase in symptoms and with significantly fewer side effects/adverse events.

The objective of this study is to assess the efficacy of Micronutrient supplement + Fish oil compared with placebo in stably medicated adults with bipolar disorder I and II, in improving nutritional status, allowing conventional medication to be effective at lower doses and with fewer side effects at the end of 52 weeks of therapy as assessed under randomized and fully blinded conditions. The primary outcome measure is a composite z-score for side effects, calculated from three separate z-scores that measure medication dosage, illness intensity (Clinical Global Impression score), and adverse side effects (UKU Side Effect score). Secondary outcomes include

* Symptom severity using the Positive and Negative Symptom Scale (PANSS)
* Mania symptoms using the Young Mania Rating Scale (YMRS)
* Anxiety symptoms using the Hamilton Anxiety scale (Ham-A)
* Depression symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS)
* Quality of life, patient-reported using My Medical Outcome Profile version 2 (MYMOP-2)
* Nutritional status using the Mini Nutritional Assessment scale (MNA)
* Functionality, patient-reported using the 24-item Behavior and Symptom Identification Scale (BASIS-24)
* Vital signs (waist circumference, body mass index, blood pressure, heart rate, and respirations)

Treatment-emergent adverse events are documented at each appointment using the Adverse Event Log. Participants are screened and their suitability for the trial confirmed at the first visit. If suitability is confirmed, informed consent is obtained and they enter the randomized phase. Participants are seen monthly for 12 months, at which time (1) their medication is optimized (graded reduction in dose by 10% per month, upwards if symptoms are above the acceptable level and downwards if an acceptable level of symptom relief has been achieved); (2) symptoms and side effects are recorded; and (3) questionnaires are administered.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double-blind, randomized clinical trial that will assign 120 stable adult outpatients with bipolar disorder, type I or II (DSM-V criteria) to supplementation with a 36-ingredient vitamin/mineral mix (Micronutrient) and an omega-3 fatty acid supplement (Fish oil) (N=72) or to matched double placebo (N=48) in a 3:2 ratio for a year.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Only one individual (unblind coordinator) will know which patients are receiving placebo and which are receiving active micronutrients. She will have no contact with the subjects. All research and clinical staff and all patients will be blinded to what they are actually receiving. The unblind coordinator has verified that the placebos appear identical in appearance to the active micronutrients. The placebos have been manufactured by the same companies that make the actual micronutrients.

Study Groups

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Micronutrient & Fish oil

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 Type EXPERIMENTAL

Micronutrient & Fish oil

Intervention Type DIETARY_SUPPLEMENT

Capsule containing a 36-ingredient micronutrient formula (EMPowerplus™) which has been widely researched for its usefulness in several psychiatric conditions. The second product is a capsule containing Fish oil (Wiley's Finest™ Wild Alaskan Fish Oil Peak EPA; 700 mg EPA plus DHA per capsule).

Olive oil & Safflower oil

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.

Group Type PLACEBO_COMPARATOR

Olive oil & Safflower oil

Intervention Type DIETARY_SUPPLEMENT

Olive oil capsule manufactured to mimic Micronutrient and safflower oil capsule manufactured to mimic Fish oil

Interventions

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Micronutrient & Fish oil

Capsule containing a 36-ingredient micronutrient formula (EMPowerplus™) which has been widely researched for its usefulness in several psychiatric conditions. The second product is a capsule containing Fish oil (Wiley's Finest™ Wild Alaskan Fish Oil Peak EPA; 700 mg EPA plus DHA per capsule).

Intervention Type DIETARY_SUPPLEMENT

Olive oil & Safflower oil

Olive oil capsule manufactured to mimic Micronutrient and safflower oil capsule manufactured to mimic Fish oil

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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EMPowerplus™ & Peak EPA

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

Participants will be excluded from the study for any of the following reasons:

1. Evidence of untreated or unstable thyroid disease (until it is treated and stabilized).
2. Known abnormality of mineral metabolism (e.g., Wilson's disease) until stabilized.
3. Unable to speak English
4. Any hypervitaminosis syndrome
5. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No