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). This study examined potential treatment effects of EMPowerPlus (EMP+), a 36-ingredient multinutrient supplement, compared to placebo in a series of single subject ABAB double-blinded trials in 12 children age 6-14 years with severe mood dysregulation (SMD) as defined by Leibenluft and colleagues (2003). Each participant was enrolled in a 12-week ABAB trial consisting of four, three-week treatment conditions alternating between active EMP+ and matched placebo. The order of treatment conditions was masked to participant and interviewer to reduce assessment bias. Hypotheses included: 1) eight completers could be recruited in 6 months; 2) children aged 6-14 could ingest the supplement with >80% compliance; 3) in comparing active treatment phases to placebo phases: a) SMD symptoms would be significantly lower (SMD-module; Irritability, Depression, and Anxiety Questionnaire [IDA]) scores would be significantly lower; b) social functioning measured by the Parent Social Validation Assessment (PSVA) would be significantly higher; and c) measures of global functioning (Clinical Global Improvement [CGI] scale; Children's Global Assessment Scale [C-GAS]) would be significantly higher.
Twelve youth were recruited in nine months. Participant compliance ranged from an average of 47.30% to 95.88% across participants. The overall sample average medication compliance while in the study was 74.11% (SD = 22.29). Including missing data from those who dropped out of the study, average compliance was 26.54% (SD = 37.81). A series of nonparametric Related Samples Friedman’s Two-Way Analysis of Variance by Ranks and Related Samples Wilcoxon Signed Rank Tests were used to analyze main outcomes comparing SMD-module, IDA, PSVA, CGI, and C-GAS during active EMP+ treatment and placebo phases for individual participants as well as aggregate group data from parent, child, and summary scores. Results showed no significant differences across treatment conditions for any outcome measures examined on an individual level. Some aggregate analyses suggest potential treatment response for symptoms of irritability. However, additional aggregate analyses failed to support such a conclusion. Low rates of compliance and high attrition limit the ability to make inferences based on the data collected during this trial. Future methodologically rigorous studies are required to determine if improved participant compliance and retention will result in support of treatment effects of EMP+ supplementation, or if results will show no significant difference between active treatment and placebo. Suggestions for future research and limitations of the current study are discussed.