Safety and Effectiveness of Long-term Treatment With Lurasidone in Children and Adolescents With Bipolar Depression: Interim Analysis of a 2-year Open-label Extension Study

Objective: To evaluate the long-term safety and efficacy of lurasidone in children and adolescents with bipolar depression.

Methods: Patients (10-17 years) with bipolar depression who completed 6 weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL) extension study in which patients were continued on lurasidone 20-80 mg/d or switched from placebo to lurasidone. The primary efficacy measure was the Children’s Depression Rating Scale, Revised (CDRS-R).

Results: At this interim analysis, 306 patients had entered the extension study, of whom 43.8% had discontinued and 25.5% were still ongoing. Mean CDRS-R total scores at DB and OL baselines were 59.0 and 39.2, respectively. Mean change from OL baseline in the CDRS-R total scores at weeks 28, 52, 76, and 104 were -9.9, -13.4, -14.3, and -14.8, respectively. Responder rates (≥50% reduction from DB baseline in CDRS-R total score) at OL baseline, and at weeks 52, and 104 were 51.0%, 88.4%, and 91.6%, respectively. The most frequent adverse events were headache (21.3%), nausea (15.1%), and somnolence (9.5%). Median changes from DB baseline to weeks 52/104 were noted for total cholesterol (-0.0/-3.0 mg/dL), triglycerides (+1.0/+6.0 mg/dL), and hemoglobin A1c (0.0/0.0 mg/dL); and mean changes in weight at weeks 52/104 were +4.2/+6.7 kg (vs. an expected weight gain of +3.8/+6.9 kg, based on CDC growth chart).

Conclusions: In children and adolescents with bipolar depression, 2 years of treatment with lurasidone was generally well-tolerated with minimal effects on weight and metabolic parameters; continued improvement was observed in depressive symptoms.

Clinicaltrials.gov identifier: NCT01914393