Evaluation of Functionally Meaningful Measures for Clinical Trials of Cognition Enhancement in Schizophrenia
Authors:
- Michael F. GreenMGMichael F. Green
- Nina R. SchoolerNSNina R. Schooler
- Robert S. KernRKRobert S. Kern
- Fred J. FreseFFFred J. Frese
- Wendy GranberryWGWendy Granberry
- Philip D. HarveyPHPhilip D. Harvey
- Craig N. KarsonCKCraig N. Karson
- Nancy PetersNPNancy Peters
- Michelle StewartMSMichelle Stewart
- Larry J. SeidmanLSLarry J. Seidman
- John SonnenbergJSJohn Sonnenberg
- William S. StoneWSWilliam S. Stone
- 1 April 2011
- journal article
- research article
- Published by American Psychiatric Association Publishing in American Journal of Psychiatry
- Vol. 168 (4) , 400-407
Abstract
Objective:Because reduction of psychotic symptoms in schizophrenia does not result in adequate community functioning, efforts have shifted to other areas, such as cognitive impairment. The U.S. Food and Drug Administration requires that drugs for cognition enhancement in schizophrenia show improvement on two distinct outcome measures in clinical trials: an accepted cognitive performance battery and a functionally meaningful coprimary measure. The authors examined the reliability, validity, and practicality of functionally meaningful measures. Method:In this four-site validation study, schizophrenia patients were assessed at baseline (N=166) and 4 weeks later (N=144) on performance-based (Independent Living Scales, Test of Adaptive Behavior in Schizophrenia [TABS], and UCSD Performance-based Skills Assessment [UPSA]) and interview-based (Cognitive Assessment Interview and Clinical Global Impression Scale for Cognition) candidate coprimary measures. In addition, cognitive performance, community functioning,...Keywords
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