Evaluation of functionally meaningful measures for clinical trials of cognition enhancement in schizophrenia.
|Title||Evaluation of functionally meaningful measures for clinical trials of cognition enhancement in schizophrenia.|
|Publication Type||Journal Article|
|Year of Publication||2011|
|Authors||Green, 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|
|Journal||The American journal of psychiatry|
|Date Published||2011 Apr|
|Keywords||Activities 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|
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.
|Alternate Journal||Am J Psychiatry|