Two Years of Lurasidone Appear Safe, Effective in Adolescents with Bipolar Depression

Up to 2 years of treatment with the antipsychotic lurasidone in children and adolescents with bipolar depression was generally safe, effective, and well-tolerated in an open-label extension study. Researchers published their findings online ahead of print in the Journal of Child and Adolescent Psychopharmacology.

“The completion rate of 55% in the study was notably high and supports the tolerability of lurasidone over 2 years of treatment. No new or unexpected adverse events were reported in the current study, and no deaths occurred,” wrote researchers from the University of Cincinnati College of Medicine and Sunovion Pharmaceuticals.

The open-label study enrolled 306 participants, ages 10 through 17, with bipolar depression who had completed 6 weeks of double-blind treatment with lurasidone or placebo. Some 63.7% of participants completed 52 weeks of treatment, and 54.9% completed a full 104 weeks of treatment. Approximately 10% of participants discontinued because of an adverse event, according to the study. Headaches, nausea, and somnolence were the most common adverse events.

Lurasidone was associated with minimal effects on weight, metabolic parameters, or prolactin. For example, average weight gains were 4.25 kilograms at week 52 and 6.75 kilograms at week 104 in participants, compared with gains of 3.76 kilograms and 6.67 kilograms, respectively, expected to occur without the medication.

Additionally, the study showed long-term improvement in depressive symptoms with lurasidone. The average change on Children’s Depression Rating Scale, Revised (CDRS-R), score was −13.4 at week 52 and −16.4 at week 104 among all participants who entered the study.

“Improvement in depression symptom severity was substantial,” researchers wrote, “with the magnitude of improvement that occurred during open-label treatment being comparable to what was observed during the initial 6-week double-blind treatment in the lurasidone group.”

—Jolynn Tumolo

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