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

نویسندگان

  • Michael F Green
  • Nina R Schooler
  • Robert S Kern
  • Fred J Frese
  • Wendy Granberry
  • Philip D Harvey
  • Craig N Karson
  • Nancy Peters
  • Michelle Stewart
  • Larry J Seidman
  • John Sonnenberg
  • William S Stone
  • David Walling
  • Ellen Stover
  • Stephen R Marder
چکیده

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.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Functional co-primary measures for clinical trials in schizophrenia: results from the MATRICS Psychometric and Standardization Study.

OBJECTIVE During the consensus meetings of the National Institute of Mental Health Measurement and Treatment Research to Improve Cognition in Schizophrenia (NIMH-MATRICS) Initiative, the U.S. Food and Drug Administration took the position that a drug for this purpose should show changes on 1) an accepted consensus cognitive performance measure and 2) an additional measure (i.e., a co-primary) t...

متن کامل

Simulating real world functioning in schizophrenia using a naturalistic city environment and single-trial, goal-directed navigation

OBJECTIVE To develop a virtual reality platform that would serve as a functionally meaningful measure of cognition in schizophrenia and that would also complement standard batteries of cognitive tests during clinical trials for cognitive treatments in schizophrenia, be amenable to human neuroimaging research, yet lend itself to neurobiological comparison with rodent analogs. METHOD Thirty-thr...

متن کامل

Adapting social neuroscience measures for schizophrenia clinical trials, part 3: fathoming external validity.

It is unknown whether measures adapted from social neuroscience linked to specific neural systems will demonstrate relationships to external variables. Four paradigms adapted from social neuroscience were administered to 173 clinically stable outpatients with schizophrenia to determine their relationships to functionally meaningful variables and to investigate their incremental validity beyond ...

متن کامل

The Role of Social Cognition in Predicting the Social Functioning in Patients With Chronic Schizophrenia

Objectives: Patients with schizophrenia are characterized with deficiencies in various aspects of social functioning. Given the relationship between social functioning deficits and relapse in these patients, identification of underlying factors is of significant importance. Thus, in this study, the contribution of each dimension of social cognition (Emotion Perception [EP], Theory of Mind [ToM]...

متن کامل

Validation of a Computerized test of Functional Capacity

Regulatory guidance for schizophrenia cognition clinical trials requires that the assessment of cognitive change is accompanied by a functionally meaningful endpoint. However, currently available measures are challenged by resistance to change, psychometric weaknesses, and for interview-based assessments, dependence upon the presence of an informant. The aims of the current study were to: 1) as...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:
  • The American journal of psychiatry

دوره 168 4  شماره 

صفحات  -

تاریخ انتشار 2011