4.3 EFFECT OF LURASIDONE ON BODY WEIGHT AND LABORATORY PARAMETERS IN ADOLESCENT PATIENTS WITH SCHIZOPHRENIA: RESULTS FROM A 6-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objectives: To evaluate the effect of short-term treatment with lurasidone on body weight, metabolic parameters, and prolactin levels in adolescent patients with schizophrenia. Methods: In a multicenter, placebo-controlled study, adolescents (13-17 years old) with schizophrenia (DSM-IV-TR criteria) were randomly assigned to 6 weeks of double-blind treatment with fixed-dose lurasidone 40 mg/d, 80 mg/d, or placebo. Safety analyses included change from baseline to week 6 in body weight (mixed-model repeated-measures analysis) and laboratory parameters (rank analysis ofcovariance [ANCOVA] with the last observation carried forward[LOCF]). Results: A total of 326 patients (mean age=15.4 years) were randomized and received lurasidone 40 mg/d (N=108), 80 mg/d (N=106), or placebo (N=112). Least-squares mean change in weight at week 6 for the lurasidone 40 mg/d, 80 mg/d, and placebo groups was 0.17 kg, 0.49 kg, and 0.05 kg, respectively. Median change at week 6 (LOCF) in total cholesterol (overall) was -4.0 mg/dL, -2.0 mg/dL, and -7.0 mg/dL, respectively; in triglycerides was -2.0 mg/dL, 7.0 mg/dL, and -2.0 mg/dL, respectively; and in glucose was 0.0 mg/dL, 1.0 mg/dL, and 0.0 mg/dL, respectively. Median change in prolactin level at week 6 (LOCF) in male patients was 0.8 ng/mL, 1.0 ng/mL, and 0.0 ng/mL for the lurasidone 40 mg/d, 80 mg/d, and placebo groups, respectively; and in female patients was 0.6 ng/mL, 4.4 ng/mL, and 0.7 ng/mL, respectively. Conclusions: Lurasidone was not associated with clinically meaningful effects on body weight, lipids, glucose, or prolactin in this placebo-controlled trial involving adolescent patients with acute schizophrenia. These findings require confirmation in longer-term studies, they but provide support for the safety of lurasidone as a potential treatment for adolescents with schizophrenia. Longer-term, open-label safety data are currently being collected.