Lurasidone Monotherapy Safe, Efficacious in Children, Adolescents With Bipolar Depression
Participants 10 to 17 years of age with bipolar I disorder who had been experiencing major depression for 1 to 12 months' duration with a CDRS-R score of ≥45 were considered for enrollment.
According to the results of a study published in the Journal of the American Academy of Child and Adolescent Psychiatry, lurasidone monotherapy was shown to improve symptoms of bipolar I depression and was well tolerated in children and adolescents.
In this 6-week randomized controlled trial, patients with bipolar I depression were randomly assigned to receive flexible doses of lurasidone (20-80 mg/d; n=175; mean age, 14.2 years; mean dosage, 33.6 mg/d) or placebo (n=172; mean age, 14.3 years). Depression symptoms were evaluated with the Children's Depression Rating Scale-Revised (CDRS-R; primary outcome) and the Clinical Global Impression-Bipolar-Severity (secondary outcome) at baseline through week 6. Treatment response was classified as at least a 50% reduction in depression symptom scores at 6 weeks. Safety and tolerability were monitored throughout the trial.
Lurasidone therapy was associated with significantly improved mean depressive symptom scores compared with placebo (−21.0 vs −15.3; P <.0001). Similarly, changes in Clinical Global Impression-Bipolar-Severity depression severity scores were significantly greater in the lurasidone group compared with the placebo group: −1.49 vs −1.05; P <.0001). Differences between the lurasidone and placebo groups were reported as early as week 2 and maintained through week 6.
At week 6, the least squares mean change in CDRS-R score was greater for the 15- to 17-year age group at −8.6, compared with the 10- to 14-year age group at −1.8. The researchers attributed the smaller change in the younger age group to a greater mean improvement at week 6 in the placebo group for participants aged 10 to 14 years (−17.3 vs −14.7).
A significantly greater proportion of participants in the lurasidone group were considered treatment responders compared with the placebo group (59.5% vs 36.5%; P <.0001), with a number needed to treat of 5. However, the proportion of participants achieving remission was not significantly different between groups (26.0% vs 18.8%; P =.082), with a number needed to treat of 14.
Lurasidone was associated with nausea and somnolence. No suicidal ideation was reported for participants in the lurasidone group. Overall, lurasidone was well tolerated.
The study authors concluded that "lurasidone (20-80 mg/d, flexibly-dosed) was associated with statistically significant and clinically meaningful improvement in depressive symptoms as assessed by the CDRS-R and [Clinical Global Impression-Bipolar-Severity] (primary and key secondary measures) at the week 6 study endpoint."
DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and safety of lurasidone in children and adolescents with bipolar I depression: a double-blind, placebo-controlled study. J Am Acad Child Adolesc Psychiatry. 2017;56(12):1015-1025.