FDA Approves Lurasidone for Pediatric Bipolar Depression
March 8, 2018   

The US Food and Drug Administration (FDA) has approved lurasidone for the treatment of major depressive episodes associated with bipolar I disorder in pediatric patients (ages 10 to 17). The approval is based on the results of a 6-week, randomized, double-blind, placebo-controlled, flexible-dose trial that included 347 pediatric patients (ages 10 to 17) with bipolar depression. Lurasidone (20–80 mg once daily) was associated with clinically and statistically significant improvement compared to placebo, as assessed by change from baseline on the Children's Depression Rating Scale, Revised (CDRS-R) total score. The most common treatment-emergent adverse effects compared to placebo were nausea, weight gain, and insomnia. Lurasidone is also approved in pediatric patients for the treatment of schizophrenia (ages 13 to 17) and in adults for the treatment of bipolar depression (monotherapy and adjunct to lithium or valproate) and schizophrenia.

Full prescribing information for lurasidone

Interested in learning more about managing mood disorders in children and adolescents? Check out the resources below.

Pre-Conference Academy: Child and Adolescent Psychiatry, November 7, 2018
Agenda and registration information
Glad, Mad, or Sad: Diagnosing and Treating Pediatric Mood Disorders (Members only)