Evaluation of functionally meaningful measures for clinical trials of cognition enhancement in schizophrenia.

TitleEvaluation of functionally meaningful measures for clinical trials of cognition enhancement in schizophrenia.
Publication TypeJournal Article
Year of Publication2011
AuthorsGreen, MF, Schooler NR, Kern RS, Frese FJ, Granberry W, Harvey PD, Karson CN, Peters N, Stewart M, Seidman LJ, Sonnenberg J, Stone WS, Walling D, Stover E, Marder SR
JournalThe American journal of psychiatry
Volume168
Issue4
Pagination400-7
Date Published2011 Apr
ISSN1535-7228
KeywordsActivities of Daily Living, Adult, Clinical Trials as Topic, cognition, Female, Humans, Interviews as Topic, Male, Neuropsychological Tests, Outcome Assessment (Health Care), Psychometrics, Quality of Life, Reproducibility of Results, Schizophrenia, Schizophrenic Psychology
Abstract

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.

DOI10.1111/j.1399-5618.2012.00989.x
Alternate JournalAm J Psychiatry