TY - JOUR
T1 - Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial
AU - Stroup, Scott
AU - Appelbaum, Paul
AU - Swartz, Marvin
AU - Patel, Mukesh
AU - Davis, Sonia
AU - Jeste, Dilip
AU - Kim, Scott
AU - Keefe, Richard
AU - Manschreck, Theo
AU - McEvoy, Joseph Patrick
AU - Lieberman, Jeffrey
N1 - Funding Information:
This article was based on results from the Clinical Antipsychotic Trials of Intervention Effectiveness project, supported with Federal funds from the National Institute of Mental Health under contract NO1 MH90001. The aim of this project is to examine the comparative effectiveness of antipsychotic drugs in conditions for which their use is clinically indicated, including schizophrenia and Alzheimer's disease. The project was carried out by principal investigators from the University of North Carolina, Duke University, the University of Southern California, the University of Rochester, and Yale University in association with Quintiles, Inc.; the program staff of the Division of Interventions and Services Research of the NIMH; and investigators from 56 sites in the United States (CATIE Study Investigators Group). AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Forest Pharmaceuticals, Inc., Janssen Pharmaceutica Products, L.P., Eli Lilly and Company, Novartis AG, Otsuka Pharmaceutical Co., Ltd., Pfizer Inc., Schering-Plough Corporation, and Zenith Goldline Pharmaceuticals, Inc., provided medications for the studies. This work was also supported by the Foundation of Hope of Raleigh, NC. CATIE Study Investigators Group include: Lawrence Adler, MD, Clinical Insights; Mohammed Bari, MD, Synergy Clinical Research; Irving Belz, MD, Tri-County/ MHMR; Raymond Bland, MD, SIU School of Medicine; Thomas Blocher, MD, MHMRA of Harris County; Brent Bolyard, MD, Cox North Hospital; Alan Buffenstein, MD, The Queen's Medical Center; John Burruss, MD, Baylor College of Medicine; Matthew Byerly, MD, University of Texas Southwestern Medical Center at Dallas; Jose Canive, MD, Albuquerque VA Medical Center; Stanley Caroff, MD, Behavioral Health Service; Charles Casat, MD, Behavioral Health Center; Eugenio Chavez-Rice, MD, El Paso Community MHMR Center; John Csernansky, MD, Washington University School of Medicine; Pedro Delgado, MD, University Hospitals of Cleveland; Richard Douyon, MD, VA Medical Center; Cyril D'Souza, MD, Connecticut Mental Health Center; Ira Glick, MD, Stanford University School of Medicine; Donald Goff, MD, Massachusetts General Hospital; Silvia Gratz, MD, Eastern Pennsylvania Psychiatric Institute; George T. Grossberg, MD, St. Louis University School of Medicine-Wohl Institute; Mahlon Hale, MD, New Britain General Hospital; Mark Hamner, MD, Medical University of South Carolina and Veterans Affairs Medical Center; Richard Jaffe, MD, Belmont Center for Comprehensive Treatment; Dilip Jeste, MD, University of California-San Diego, VA Medical Center; Anita Kablinger, MD, Louisiana State University Health Sciences Center; Ahsan Khan, MD, Psychiatric Research Institute; Steven Lamberti, MD, University of Rochester Medical Center; Michael T. Levy, MD, PC, Staten Island University Hospital; Jeffrey Lieberman, MD, University of North Carolina at Chapel Hill; Gerald Maguire, MD, University of California Irvine; Theo Manschreck, MD, Corrigan Mental Health Center; Joseph McEvoy, MD, Duke University Medical Center; Mark McGee, MD, Appalachian Psychiatric Healthcare System; Herbert Meltzer, MD, Vanderbilt University Medical Center; Alexander Miller, MD, University of Texas Health Science Center at San Antonio; Del D. Miller, MD, University of Iowa; Henry Nasrallah, MD, University of Cincinnati Medical Center; Charles Nemeroff, MD, PhD, Emory University School of Medicine; Stephen Olson, MD, University of Minnesota Medical School; Gregory F. Oxenkrug, MD, St. Elizabeth's Medical Center; Jayendra Patel, MD, University of Mass Health Care; Frederick Reimherr, MD, University of Utah Medical Center; Silvana Riggio, MD, Mount Sinai Medical Center-Bronx VA Medical Center; Samuel Risch, MD, University of California-San Francisco; Bruce Saltz, MD, Henderson Mental Health Center; Thomas Simpatico, MD, Northwestern University; George Simpson, MD, University of Southern California Medical Center; Michael Smith, MD, Harbor- UCLA Medical Center; Roger Sommi, PharmD, University of Missouri; Richard M. Steinbook, MD, University of Miami School of Medicine; Michael Stevens, MD, Valley Mental Health; Andre Tapp, MD, VA Puget Sound Health Care System; Rafael Torres, MD, University of Mississippi; Peter Weiden, MD, SUNY Downstate Medical Center; James Wolberg, MD, Mount Sinai Medical Center.
Funding Information:
This project was supported by NIH Research Grant #1 K23 MH67002-01A1 funded by the National Institute of Mental Health and the Office of the Director, Office of Behavioral and Social Research (OD/OBSSR), and by the National Association of Research in Schizophrenia and Affective Disorders.
PY - 2005/12/1
Y1 - 2005/12/1
N2 - 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. Method: 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.
AB - 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. Method: 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.
KW - Cross-sectional study
KW - Informed consent
KW - Mental competency
KW - Research subjects
KW - Schizophrenia
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U2 - 10.1016/j.schres.2005.08.007
DO - 10.1016/j.schres.2005.08.007
M3 - Article
C2 - 16182516
AN - SCOPUS:27744497490
SN - 0920-9964
VL - 80
SP - 1
EP - 8
JO - Schizophrenia Research
JF - Schizophrenia Research
IS - 1
ER -