Objective: Current psychotropic medications for childhood bipolar spectrum disorders (BPSD) are associated with significant adverse events. As nutrients play an important role in physical and mental health, they may be useful in treating mood disorders with few side effects. This open-label study explored the feasibility of testing therapeutic effects of a multinutrient supplement, Truehope EMPowerplus, for pediatric BPSD.
Design: Truehope EMPowerplus started at 1 capsule t.i.d. and escalated to a goal of 4 capsules t.i.d., which eight children attained. Four of these increased to the maximum dose, 5 capsules t.i.d. Mood symptoms were assessed seven times over eight weeks.
Subjects: Ten children, age 6-12 with BPSD were enrolled in 6.5 months. Seven participants completed the full trial. Three dropped out due to palatability and/or adherence issues.
Result: Mean medication adherence was 91%. With one-tailed nonparametric Fisher’s Randomization Tests, intent-to-treat analyses demonstrated a 37% decrease in depression scores (p<0.06) and a 45% decrease in mania scores (p<0.01) from the start of treatment through final visit, suggesting improvement and possible treatment response. Study completers demonstrated significant decreasing trends in both depression and mania scores from baseline to final visit (p<0.05). Side effects were minor and transient, mostly temporary gastric discomfort.
Conclusion: Future randomized, placebo-controlled trials of Truehope EMPowerplus are warranted and feasible.