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Psych Congress  

Effect of Lurasidone on Cognition in Children and Adolescents With Bipolar Depression: Interim Analysis of a 2-year Open-label Extension Study

Authors  

Katherine Burdick, PhD – Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Robert Goldman, Head, Global Clinical Research and Medical Affairs – Sunovion Pharmaceuticals Inc.; Michael Tocco, Medical Director – Sunovion Pharmaceuticals Inc.; Ling Deng, PhD – Sunovion Pharmaceuticals Inc.; Antony Loebel, MD – Sunovion Pharmaceuticals Inc.

Sponsor  
Sunovion Pharmaceuticals Inc.Clinicaltrials.gov identifier: NCT01914393

Objective: To evaluate the long-term effects of lurasidone on cognition in children and adolescents with bipolar depression.

Methods: Patients (10-17 years) 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. Cognitive function was assessed with the Brief CogState battery, which evaluates four cognitive domains: processing speed, attention, visual learning, and working memory. Based on normative data, Z-scores were calculated. Results presented here are based on an interim analysis of data at 1-year.

Results: At interim analysis, 306 patients had entered the extension study. CogState data were available at OL baseline, weeks 28, 52, and 52 (LOCF) on 300, 225, 189, and 284 patients, respectively. The Cogstate Z-score indicated impairment at DB baseline on the composite score (-0.92), and in processing speed (-1.31), attention (-1.45), visual learning (-0.18), and working memory (-0.33). Mean change in Z-score, from DB baseline to OL-baseline, 28, 52, and 52-LOCF, respectively, were observed for the cognitive composite (+0.04, +0.23, +0.26, and +0.23), and for the CogState domains processing speed (-0.07, +0.21, +0.15, and +0.15), attention (+0.02, +0.20, +0.26, and +0.21), visual learning (+0.03, +0.21, +0.37, and +0.28), and working memory (+0.02, +0.09, +0.03, and -0.06).

Conclusions: Child and adolescent patients with bipolar depression who were treated with lurasidone did not demonstrate deleterious effects in cognitive performance as measured by the brief Cogstate battery during 1-year of open-label treatment.

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