Objective: The aim of the current study was to evaluate the long-term safety and effectiveness of lurasidone in pediatric bipolar depression.
Method: Patients 10-17 years with bipolar I depression who completed 6 weeks of double-blind (DB), placebo-controlled treatment with lurasidone were enrolled in a 2-year, open-label (OL) study of lurasidone (20-80 mg/d). The primary efficacy measure was the Children’s Depression Rating Scale, Revised (CDRS-R).
Results: 306 patients entered the extension study; 195 completed 52 weeks, and 168 completed 104 weeks. Mean CDRS-R total score at DB baseline was 59.4 in patients treated with lurasidone (ie, LUR-LUR), and 58.7 in patients treated with placebo (ie, PBO-LUR); and mean CDRS-R total score at OL baseline (after 6 weeks of DB treatment) was 36.6 in the LUR-LUR group and 41.9 in the PBO-LUR group. Mean change from OL baseline in CDRS-R total scores at weeks 52 and 104 were -13.4 and -16.4, respectively. The most frequent adverse events were headache (23.9%), nausea (16.4%) and somnolence (combined) (12.1%). Small median changes from DB baseline to weeks 52/104 were noted for total cholesterol (0.0/-2.5 mg/dL) and triglycerides (+1.0/+8.0 mg/dL); and mean changes in weight at weeks 52/104 were +4.3/+6.8 kg (vs. an expected weight gain of +3.8/+6.7 kg, based on age-and-gender adjusted CDC growth chart).
Conclusion: Two years of treatment with lurasidone in children and adolescents with bipolar depression was well-tolerated and associated with few effects on weight and metabolic parameters. Patients also continued to experience improvement in depressive symptoms during long-term treatment with lurasidone.