Sunovion announced positive results from a Phase 3 study of Latuda (lurasidone HCI) in children aged 10 to 17 years with major depressive episodes associated with bipolar I disorder.

This placebo-controlled study included 347 individuals aged 10 to 17 with bipolar depression. Individuals were randomized to receive either once-daily Latuda 20-80mg or placebo. Results showed a statistically significant change from baseline to Week 6 in favor of Latuda vs. placebo in the Clinical Global Impression-Bipolar Version, Severity of Illness (CBI-BP-S) score (–1.49 vs. –1.05; effect size = 0.44, P<0.0001) and the Children’s Depression Rating Scale, Revised (CDRS-R) score (–21.0 vs. –15.3; effect size = 0.45, P<0.0001).

“More treatments are needed that not only improve bipolar depression symptoms in children and adolescents, but that are also well-tolerated,” said Kiki Chang, MD, Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center. 

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The most common side effects for Latuda versus placebo were nausea (16% vs. 5.85%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs 2.3%).

The full data from this study will be presented at the 2017 Annual Meeting of the American Psychiatric Association, it has also been sent to the Food and Drug Administration to support a supplemental New Drug Application (sNDA).

Latuda, an atypical antipsychotic, is already approved for the treatment of major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate in adults and for the treatment of schizophrenia in patients  ≥13 years of age.

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