Current treatments for childhood mood dysregulation rely on psychotropic medications that are associated with significant adverse events (Kowatch et al., 2005). Human nutrition research suggests nutrients play an important role in physical and mental health and may be useful in treating mood dysregulation without the side effects of contemporary pharmaceuticals (Kaplan, Crawford, Field, & Simpson 2007). The current open-label study explored the feasibility of testing possible therapeutic effects of a multinutrient supplement, EMPowerplus (EMP+), as treatment for childhood mood dysregulation. Ten children, age 6-12 with mood dysregulation were recruited. All received EMP+ treatment. Mood symptoms were assessed seven times over an eight week trial. Blood draws were taken at baseline and final visits for nutrient analyses. Hypotheses included: 1) The sample can be recruited in 5 months; 2) Children aged 6-12 can swallow the supplement with >80% compliance; 3) Micronutrient levels of iron, copper, magnesium and zinc and vitamins B1, B6, B12, E and folate will increase after eight weeks of supplementation; 4) Depression scores, measured by the KDRS, will show a decreasing trend over the course of supplement treatment; and 5) Mania scores, measured by the KMRS, will show a decreasing trend over the course of supplement treatment.
Results showed recruitment was completed in 6.5 months. Three participants terminated due to palatability and compliance issues. The mean sample compliance rate was approximately 91%. Of the seven study completers, all maintained at least 93% compliance and two maintained 100% compliance. Twelve, one-tailed Fisher Randomization Tests were computed, showing significant increases in blood levels of vitamins A, B6, D, E (alpha tocopherol) and folate from pre- to post-supplementation for the seven study completers (p<0.05). Two, one-tailed Fisher Randomization Tests showed significant decreasing trends in depression and mania scores for the seven study completers from baseline to the final visit, suggesting improvement and possible treatment response (p<0.05). Overall, results of this feasibility trial suggest recruitment for future studies is possible and may improve with summer recruitment. Also, children who meet swallowing inclusion criteria will likely have high medication compliance, but those who struggle swallowing capsules may not benefit from this intervention. This trial also shows children tolerate fasting and blood draw procedures well. Lastly, although open-label, significant decreasing trends in depression and mania scores throughout supplementation suggest future randomized, placebo-controlled trials of EMP+ are warranted. Suggestions for future research and limitations of the current study are discussed.