BANGOR, Maine – A cutting edge study on the effect of micronutrients as a supporting treatment for bipolar disorder is currently underway in Bangor, Maine, led by Lewis Mehl-Madrona, MD, at Northern Light Family Medicine and Residency.
“The purpose of this 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.
A follow-up open label phase will allow all participants, including those previously taking the placebo, to try the active micronutrient treatment for an additional twelve months.
Additional Participants Needed
The objective of this study is to assess the effectiveness of a micronutrient supplement + fish oil compared with placebo. To achieve this, the study needs a total of one hundred subjects who complete the first twelve months of the study. The prevalence of this disorder in the general population is only 3% and it has been difficult to recruit sufficient subjects. Researchers need to recruit and enroll an additional fifty people in the study. All participants must live in the vicinity of Bangor, Maine. Those interested in enrolling in the study should contact Edwina at 207.973.9013.
Additional Funding for Open Label Phase Needed
Once the study participants complete the first twelve months of the randomized study they will transition onto the open label phase of the study. This is less intensive but will still involve quarterly check in, data collected and the micronutrient supplement + fish oil dispensed to participants by the researchers.
Our hypothesis is the micronutrients and fish oil improves nutritional status and as we do not know the nutritional baseline of participants at the start the study, the longer we can follow the participants the better we will be able to understand the impact of taking this dose of vitamins over time. To achieve this we will need an additional $25,000 so the participants can check in quarterly, the data collected and the analysis completed.
The study was first made possible by a generous donor to Dr. Bonnie Kaplan’s Nutrition & Mental Health Research Fund at the Foundation for Excellence in Mental Health Care.
“Evidence is steadily growing for the relationship between dietary quality and mental health, and for the select use of nutrient-based supplements to address nutritional deficiencies,” explains Lewis Mehl-Madrona, MD, the study’s principal investigator.
Some of the earliest research studies on nutrients relevant to mental illness observed irritability and mood problems in people known to be deficient in the B vitamins, while recent work on folic acid (vitamin B9) suggests that low levels may be associated with depressive symptomatology and poor response to antidepressant medication. There are roughly 90 years of scientific literature demonstrating the relevance of dietary nutrients for mental health, forming the rationale for including the use of micronutrients. These are compelling reasons to explore the role of nutrition in the treatment of psychiatric disorders.
Detailed Study Description
Bipolar disorder is a common neuropsychiatric illness with mortality rates elevated among people with bipolar disorder compared to the general population
Many of the medications used to treat bipolar disorder increase the risk for acute kidney injury, cataracts, decreased cognitive function, increased risk for myocardial infarction and stroke, metabolic syndrome such as type 2 diabetes mellitus and dyslipidemia. Also, psychiatric disorders are prevalent and costly to families and society.
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 Micronutrient + Fish oil to placebo, respectively. All patients are stable, medicated adult outpatients with bipolar disorder (type I or type II). Medical supervision is provided with monthly appointments. At the end of the twelve months, all participants will be offered the opportunity of entering an additional twelve month 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 stable 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 twelve months 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)
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 (2) symptoms and side effects are recorded; and (3) questionnaires are administered.