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After six weeks, youth with bipolar depression assigned to daily lurasidone showed significant improvements in their Children’s Depression Rating Scale–Revised (CDRS-R) scores compared with those assigned to placebo. Youth taking lurasidone also demonstrated improvements in anxiety, quality of life, and global functioning.
“In addition to significantly higher responder rates in patients treated with lurasidone versus placebo, the clinical relevance of improvement in the lurasidone group is underscored by the observed change in mean [global functioning] score from <50 at baseline (‘moderate-to-severe impairment in functioning’) to >60 at study endpoint (‘generally functioning pretty well’),” wrote Melissa DelBello, M.D., of the University of Cincinnati College of Medicine and colleagues. “The consistency of improvement across primary, key secondary, and all other secondary efficacy measures further substantiates the overall effectiveness of lurasidone in this pediatric population with bipolar depression.”
This study included 347 pediatric patients aged 10 to 17 with bipolar I disorder and CDRS-R scores of at least 45. The participants were randomly assigned to either lurasidone (20-80 mg daily) or placebo. At the study endpoint, CDRS-R total scores dropped 21 points in the lurasidone group compared with 15.3 points in the placebo group. Overall response rates (≥50% reduction from baseline to week 6 in CDRS-R total score) were 59.5% and 36.5% for the lurasidone and placebo groups, respectively.
DelBello and colleagues noted the improvements seen in the current study were comparable to those seen in a clinical trial of olanzapine/fluoxetine combination (OFC) therapy, but lurasidone had a better tolerability profile.
The dropout rates among patients due to adverse events were low and similar for both groups in the lurasidone study (1.7% compared with 14.1% in the aforementioned OFC study). The two most common adverse events among patients taking lurasidone were nausea and somnolence. There were no significant differences in weight gain between lurasidone and placebo groups.
For related information, see the FOCUS article “Management of Bipolar Disorder in Children and Adolescents,” by DelBello and colleagues.
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