Effect of Lurasidone on Cognition in Adolescents With Schizophrenia: Analysis of a 2-year Open-label Extension Study

Objective: To evaluate the short and long-term effects of lurasidone on cognitive performance in adolescents with schizophrenia.

Methods: Patients ages 13-17 with schizophrenia who completed 6 weeks of double-blind (DB) fixed-dose treatment with lurasidone were eligible to enroll in a 2-year, open-label (OL), flexible-dose (20-80 mg/d) extension study. Cognitive function was assessed with the Brief CogState battery, which evaluates 4 cognitive domains: psychomotor speed, attention, visual learning, and working memory. Based on normative data, Z-scores were calculated for each of the 4 cognitive domains, and for an overall composite score.

Results: After 6 weeks of DB treatment, mean change in cognitive composite Z-score was -0.09, +0.11, and -0.10 for lurasidone 40 mg and 80 mg, and placebo, respectively. A total of 271 patients completed 6 weeks of DB treatment and entered the 2-year OL study. The sample sizes with Cogstate data available at each assessment time-point were: OL-baseline (n=267), week 28 (n=206), week 52 (n=182), Week 76 (n=167), and week 104 (n=147). Mean change in Z-score, from DB baseline to OL weeks 0 (OL-baseline), 28, 52, 76, and 104, respectively, were observed for the cognitive composite (+0.04, +0.16, +0.18, +0.03, +0.06), and for the CogState domains psychomotor speed (-0.08, -0.01, -0.05, -0.35, -0.39), attention (-0.00, -0.01, -0.08, -0.29, -0.44), visual learning (+0.19, +0.46, +0.64, +0.70, +0.93), and working memory (+0.18, +0.25, +0.59, +0.52, +0.48).

Conclusions: Over the course of this 2-year study of adolescents with schizophrenia, treatment with lurasidone was not associated with deleterious effects on overall cognitive function.