title: Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial.
abstract: OBJECTIVE
  Uncertainty regarding the degree to which persons with schizophrenia may lack decision-making capacity, and what the predictors of capacity may be led us to examine the relationship between psychopathology, neurocognitive functioning, and decision-making capacity in a large sample of persons with schizophrenia at entry into a clinical trial.
  
  
  METHODS
  In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial, a clinical trial sponsored by the National Institute of Mental Health designed to compare the effectiveness of antipsychotic drugs, subjects were administered the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) and had to demonstrate adequate decision-making capacity before randomization. The MacCAT-CR, the Positive and Negative Syndrome Scale (PANSS), and an extensive neurocognitive battery were completed for 1447 study participants.
  
  
  RESULTS
  The neurocognitive composite score and all 5 neurocognitive subscores (verbal memory, vigilance, processing speed, reasoning, and working memory) were positive correlates of the MacCAT-CR understanding, appreciation, and reasoning scales at baseline. Higher levels of negative symptoms, but not positive symptoms, were inversely correlated with these three MacCAT-CR scales. Linear regression models of all three MacCAT-CR scales identified working memory as a predictor; negative symptoms made a small contribution to the understanding and appreciation scores.
  
  
  CONCLUSIONS
  Negative symptoms and aspects of neurocognitive functioning were correlated with decision-making capacity in this large sample of moderately ill subjects with schizophrenia. In multiple regression models predicting performance on the MacCAT-CR scales, working memory was the only consistent predictor of the components of decision-making capacity. Individuals with schizophrenia who have prominent cognitive dysfunction, especially memory impairment, may warrant particular attention when participating in research.
authors.affiliation: Department of Psychiatry, University of North Carolina at Chapel Hill, CB# 7160, Chapel Hill, NC 27599-7160, USA. sstroup@med.unc.edu
authors.forename: Scott
authors.initials: S
authors.lastname: Stroup
authors.forename: Paul
authors.initials: P
authors.lastname: Appelbaum
authors.forename: Marvin
authors.initials: M
authors.lastname: Swartz
authors.forename: Mukesh
authors.initials: M
authors.lastname: Patel
authors.forename: Sonia
authors.initials: S
authors.lastname: Davis
authors.forename: Dilip
authors.initials: D
authors.lastname: Jeste
authors.forename: Scott
authors.initials: S
authors.lastname: Kim
authors.forename: Richard
authors.initials: R
authors.lastname: Keefe
authors.forename: Theo
authors.initials: T
authors.lastname: Manschreck
authors.forename: Joseph
authors.initials: J
authors.lastname: McEvoy
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lieberman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use; D003072:Cognition Disorders / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology*; D003430:Cross-Sectional Studies; D003657:Decision Making; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D012559:Schizophrenia / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D012720:Severity of Illness Index
chemical_list: D014150:Antipsychotic Agents