Cited by 159Schizophrenia research and treatmentPsychological Testing and AssessmentDementia and Cognitive Impairment Research

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Evaluation of Functionally Meaningful Measures for Clinical Trials of Cognition Enhancement in Schizophrenia

Green, Michael F., Schooler, Nina R., Kern, Robert S., Frese, Fred J., Granberry, Wendy, Harvey, Philip D., Karson, Craig N., Peters, Nancy, Stewart, Michelle, Seidman, Larry J., Sonnenberg, John, Stone, William S., Walling, David, Stover, Ellen, Marder, Stephen R.·2011·American Journal of Psychiatry

DOI 10.1176/appi.ajp.2010.10030414

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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, and clinical symptoms were assessed. Both full and short forms of the performance-based measures were evaluated. RESULTS: All measures were well tolerated by patients, had adequate test-retest reliability, and showed good utility as a repeated measure. Measures differed in their correlation with cognitive performance, with performance-based measures having stronger correlations than interview-based measures. None of the measures had notable floor or ceiling effects or missing data. CONCLUSIONS: Among the full-form measures, the UPSA was judged to have the strongest overall properties. Among the short forms, the TABS and UPSA appeared to have the strongest features. Use of the short forms saves time, but at the cost of lower test-retest reliability and weaker correlations with cognitive performance.

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Authors: Green, M. F., Schooler, N. R., Kern, R. S., Frese, F. J., Granberry, W., Harvey, P. D., Karson, C. N., Peters, N., Stewart, M., Seidman, L. J., Sonnenberg, J., Stone, W. S., Walling, D., Stover, E., & Marder, S. R.
Affiliations: Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Corresponding author: Green, Michael F.
ORCID: Green, Michael F.
Schooler, Nina R.
Kern, Robert S.
Harvey, Philip D.
Seidman, Larry J.
Stone, William S.
Walling, David
Marder, Stephen R.
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2011-04
Volume: 168
Issue: 4
Pages: 400-407
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/appi.ajp.2010.10030414
OpenAlex: W2151080668
Cited by: 159
References: 23
Citations by year: 2026: 3 · 2025: 4 · 2024: 5 · 2023: 3 · 2022: 11 · 2021: 3 · 2020: 7 · 2019: 8 · 2018: 13 · 2017: 6 · 2016: 12 · 2015: 18 · 2014: 12 · 2013: 18 · 2012: 23
FWCI: 14.20
Type: journal article
Language: en
Open access: closed
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Funders: U.S. Public Health Service (HHSN278 200441003C)
National Institute of Mental Health (MH042392)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Social Sciences › Psychology › Applied Psychology › Psychological Testing and Assessment
Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Keywords: schizophrenia, cognitive enhancement, community functioning, test-retest reliability, performance-based measures, cognitive impairment
MeSH terms: Activities of Daily Living, Adult, Clinical Trials as Topic, Cognition, Female, Humans, Interviews as Topic, Male, Neuropsychological Tests, Psychometrics, Quality of Life, Schizophrenia, Schizophrenic Psychology, Reproducibility of Results, Outcome Assessment, Health Care

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Evaluation of Functionally Meaningful Measures for Clinical Trials of Cognition Enhancement in Schizophrenia

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