The Efficacy and Safety of Lurasidone in Adolescent Patients with Schizophrenia: Results of Functional and Quality of Life Measures from a 6-week, Double-blind, Placebo-controlled Study

Abstract

Introduction

Lurasidone, an atypical antipsychotic, demonstrated efficacy and safety in adults with schizophrenia.

Objective/Aims

To evaluate the efficacy and safety of lurasidone in adolescent patients with schizophrenia.

Methods

Adolescents (13–17 years old) with schizophrenia were randomly assigned to six weeks of double-blind treatment with lurasidone 37 mg/day, 74 mg/day or placebo. An ANCOVA using an LOCF approach was performed to assess change from baseline on secondary study endpoints: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) and Children's Global Assessment Scale (CGAS).

Results

Patients were randomized to lurasidone 37 mg/d (n = 108), 74 mg/day (n = 106), or placebo (n = 112). Placebo-adjusted LS mean improvement at week 6 on the PQ-LES-Q was 5.3 (P = 0.001) and 5.8 (P < 0.001) for the 37 mg/day and 74 mg/day groups, respectively; and, on the CGAS was 4.6 (P = 0.002) and 4.9 (P < 0.001) for the 37 mg/day and 74 mg/d groups, respectively. The most common adverse events occurring at ≥ 5% in either lurasidone group and at least twice the rate of placebo were: nausea, somnolence, akathisia, vomiting and sedation. Mean change in weight at week 6 for placebo, 37 mg/day, and 74 mg/day groups was 0.05 kg, 0.17 kg, and 0.49 kg, respectively. Lurasidone treated patients did not show clinically meaningful differences from placebo on laboratory measures of cholesterol, triglycerides, glucose, and prolactin.

Conclusions

Adolescent patients with schizophrenia treated with lurasidone demonstrated significant improvement in quality of life and function. Lurasidone was generally well-tolerated and associated with minimal changes in weight and metabolic parameters. Sponsored by Sunovion Pharmaceuticals Inc. ClinicalTrials.gov identifier: NCT01911429.

Disclosure of interest

Dr. Findling receives or has received research support, acted as a consultant and/or served on a speaker's bureau for Alcobra, American Academy of Child & Adolescent Psychiatry, American Physician Institute, American Psychiatric Press, Bracket, CogCubed, Cognition Group, Coronado Biosciences, Dana Foundation, Elsevier, Forest, Guilford Press, Ironshore, Johns Hopkins University Press, Jubilant Clinsys, KemPharm, Lundbeck, Merck, NIH, Neurim, Novartis, Otsuka, Oxford University Press, Pfizer, Physicians Postgraduate Press, Purdue, Rhodes Pharmaceuticals, Roche, Sage, Shire, Sunovion, Supernus Pharmaceuticals, Transcept Pharmaceuticals, Tris, Validus, and WebMD. Drs. Goldman, Cucchiaro, Deng, and Loebel are employees of Sunovion Pharmaceuticals Inc.