OBJECTIVE: The aim of this study was to evaluate the effects of aripiprazole treatment on individual Young Mania Rating Scale (YMRS) line items in pediatric subjects with manic or mixed episodes associated with bipolar I disorder to better understand the discrete symptom improvements. METHODS: This was a post hoc analysis of the YMRS line item data from a 4-week, multicenter, randomized, double-blind, placebo-controlled study. Two hundred ninety-six eligible subjects were randomized to aripiprazole 10 mg/day (n = 98), aripiprazole 30 mg/day (n = 99), or placebo (n = 99). The primary endpoint was the mean change in YMRS total scores from baseline to week 4. Effect sizes and treatment effect on individual line items were calculated. RESULTS: Of the 296 subjects, 237 (80.1%) completed the 4-week study. Seven of the 11 YMRS line items showed a statistically significant improvement in both aripiprazole treatment groups versus placebo. Using the data for the pooled doses, the three YMRS line items with the greatest effect size at week 4 were irritability (effect size = 0.7; treatment effect = 1.43; p < 0.001), aggressive behavior (effect size = 0.7; treatment effect = 1.38; p < 0.001), and increased motor activity/energy (effect size = 0.6; treatment effect = 0.86; p < 0.001). CONCLUSION:Aripiprazole improved a broad spectrum of symptoms across the YMRS scale.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate the effects of aripiprazole treatment on individual Young Mania Rating Scale (YMRS) line items in pediatric subjects with manic or mixed episodes associated with bipolar I disorder to better understand the discrete symptom improvements. METHODS: This was a post hoc analysis of the YMRS line item data from a 4-week, multicenter, randomized, double-blind, placebo-controlled study. Two hundred ninety-six eligible subjects were randomized to aripiprazole 10 mg/day (n = 98), aripiprazole 30 mg/day (n = 99), or placebo (n = 99). The primary endpoint was the mean change in YMRS total scores from baseline to week 4. Effect sizes and treatment effect on individual line items were calculated. RESULTS: Of the 296 subjects, 237 (80.1%) completed the 4-week study. Seven of the 11 YMRS line items showed a statistically significant improvement in both aripiprazole treatment groups versus placebo. Using the data for the pooled doses, the three YMRS line items with the greatest effect size at week 4 were irritability (effect size = 0.7; treatment effect = 1.43; p < 0.001), aggressive behavior (effect size = 0.7; treatment effect = 1.38; p < 0.001), and increased motor activity/energy (effect size = 0.6; treatment effect = 0.86; p < 0.001). CONCLUSION:Aripiprazole improved a broad spectrum of symptoms across the YMRS scale.