OBJECTIVES: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, EMPowerplus™ (EMP+), for pediatric BPSD. DESIGN:EMP+ was started at one capsule t.i.d. and escalated to a goal of four capsules t.i.d., which eight children attained. Four (4) of these increased to the maximum dose, five capsules t.i.d. Mood symptoms were assessed seven times over 8 weeks. SUBJECTS:Ten (10) children, age 6-12 with BPSD, were enrolled in 6.5 months. Seven (7) participants completed the full trial. Three (3) dropped out due to palatability and/or adherence issues. RESULTS: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. CONCLUSIONS: Future randomized, placebo-controlled trials of EMP+ are warranted and feasible.
RCT Entities:
OBJECTIVES: 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, EMPowerplus™ (EMP+), for pediatric BPSD. DESIGN: EMP+ was started at one capsule t.i.d. and escalated to a goal of four capsules t.i.d., which eight children attained. Four (4) of these increased to the maximum dose, five capsules t.i.d. Mood symptoms were assessed seven times over 8 weeks. SUBJECTS: Ten (10) children, age 6-12 with BPSD, were enrolled in 6.5 months. Seven (7) participants completed the full trial. Three (3) dropped out due to palatability and/or adherence issues. RESULTS: 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. CONCLUSIONS: Future randomized, placebo-controlled trials of EMP+ are warranted and feasible.
Authors: L Eugene Arnold; Mary A Fristad; Barbara L Gracious; Jeanette M Johnstone; Bonnie J Kaplan; Charles W Popper; Julia J Rucklidge Journal: Prim Care Companion CNS Disord Date: 2016-04-28
Authors: Elisabeth A Frazier; Barbara Gracious; L Eugene Arnold; Mark Failla; Chureeporn Chitchumroonchokchai; Diane Habash; Mary A Fristad Journal: J Child Adolesc Psychopharmacol Date: 2013-10 Impact factor: 2.576