Objective: To evaluate the effect of micronutrients (minerals and vitamins) on adult psychosis when added to conventional medications by using a placebo-controlled randomized design with a 1-month open-label run-in.
Design: Longitudinal comparison study following a randomized, controlled trial that had failed because participants declined to undergo randomization.
Setting/Locations: Rural primary care and psychiatry clinic in northern New England (town of 16,000 people).
Participants: People older than age 18 years diagnosed with a psychotic disorder who were receiving medications.
Intervention: Fifty consecutive clients seen in 1 month’s time were invited to participate; 19 completed a 1-month open-label phase of the addition of a micronutrient to their medication regimen; all 19 then withdrew rather than risk randomization to a placebo. This finding itself was important, so the study was restructured to compare the response of those 19 patients during 24 months of micronutrients + medication to the response of the 31 people who declined participation, enriched by an additional 28 consecutive patients recruited over the second month of the study. This yielded a total of 59 patients who received medication without micronutrients.
Outcome measures: All clients were evaluated with the Positive and Negative Symptom Scale and the Clinical Global Impression scale at study baseline and after 3, 6, 9, 12, 15, 18, and 24 months. Psychosis was confirmed with clinical interview by using Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, criteria. All participants had normal physical examinations and laboratory studies.
Results: Outcomes were similar for both groups until 15 months, although the micronutrient group used significantly less antipsychotic medication throughout that time ( p < 0.001). At 15 months, the micronutrients + medication group exhibited significantly fewer symptoms than the medication-only group, a difference that was even stronger at 24 months.
Conclusions: Micronutrients may appear to be a beneficial long-term, adjunctive strategy for people with psychotic disorders, allowing for smaller doses of medication to achieve the same effectiveness with fewer side effects.