Micronutrients as Adjunctive Treatment for Bipolar Disorder

NCT03541031 | Unknown DMC

• 1 other identifier: 17-1-M-354
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in Side Effects

  A composite z-score calculated from three separate z-scores for: (1) medication dosage, measured in haloperidol equivalents, valproic acid equivalents, lithium dose, fluoxetine equivalents, or lorazepam equivalents; (2) Clinical Global Impression (CGI) score, a measure of schizophrenia symptoms and illness at the time of assessment, with scores ranging from 1 (not at all ill) to 7 (extremely ill); and (3) UKU Side Effect score, which rates 48 single items of adverse side effects, clustered into four subgroups (psychic, neurological, autonomic and other side effects), on a scale of 1 to 4.

  Baseline and every month for 1 year

Secondary Outcomes (12)

• Changes in Symptom Severity

  Baseline and every 3 months for 1 year

• Changes in Mania Symptoms

  Baseline and every 3 months for 1 year

• Changes in Anxiety Symptoms

  Baseline and every 3 months for 1 year

• Changes in Depression

  Baseline and every 3 months for 1 year

• Changes in Quality of Life (patient-reported)

  Baseline and every month for 1 year

Study Arms (2)

Micronutrient & Fish oil

EXPERIMENTAL

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.

Dietary Supplement: Micronutrient & Fish oil

Olive oil & Safflower oil

PLACEBO COMPARATOR

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.

Dietary Supplement: Olive oil & Safflower oil

Interventions

Micronutrient & Fish oil 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).

Also known as: EMPowerplus™ & Peak EPA

Micronutrient & Fish oil

Olive oil & Safflower oil DIETARY_SUPPLEMENT

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

Olive oil & Safflower oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eastern Maine Medical Center: lead

Study Sites (1)

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Micronutrients; Fish Oils; Olive Oil; Safflower Oil

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Lewis Mehl-Madrona, MD, PhD

  Eastern Maine Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Michaud, BS

CONTACT

207-973-7175; dmichaud@emhs.org

Janet Bayleran, PhD

CONTACT

207-973-7352; jbayleran@emhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: May 30, 2018
• Study Start: May 29, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

US (1)