NCT03541031.

Study name	Micronutrients as Adjunctive Treatment for Bipolar Disorder
Methods	Randomised controlled trial
Participants	Stable adult outpatients with bipolar disorder, type I or II (DSM‐V criteria)
Interventions	Supplementation with a 36‐ingredient vitamin/mineral mix (Micronutrient) and an omega‐3 fatty acid supplement (fish oil) vs matched double placebo in a 3:2 ratio for a year
Outcomes	Primary outcome: Composite z‐score for side effects, calculated from 3 separate z‐scores that measure medication dosage, illness intensity (Clinical Global Impression score), and adverse side effects (UKU Side Effect score) Secondary outcomes: Symptom severity based on the Positive and Negative Symptom Scale (PANSS) Mania symptoms based on the Young Mania Rating Scale (YMRS) Anxiety symptoms based on the Hamilton Anxiety Scale (HAM‐A) Depression symptoms based on the Montgomery‐Asberg Depression Rating Scale (MADRS) Quality of life, patient‐reported by My Medical Outcome Profile version 2 (MYMOP‐2) Nutritional status based on the Mini Nutritional Assessment scale (MNA) Functionality, patient‐reported on the 24‐item Behavior and Symptom Identification Scale (BASIS‐24) Vital signs (waist circumference, body mass index, blood pressure, heart rate, respirations)
Starting date	May 2018
Contact information	Principal Investigator: Lewis Mehl‐Madrona, MD, PhD Eastern Maine Medical Center
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