TY - JOUR
T1 - Characteristics of the MATRICS Consensus Cognitive Battery in a 29-site antipsychotic schizophrenia clinical trial
AU - Keefe, Richard S.E.
AU - Fox, Kolleen Hurley
AU - Harvey, Philip D.
AU - Cucchiaro, Josephine
AU - Siu, Cynthia
AU - Loebel, Antony
N1 - Funding Information:
This study was designed and supported by Dainippon Sumitomo Pharma America . NeuroCog Trials trained the cognitive testers and conducted data quality review. Analyses were completed by Dr. Cynthia Sui in consultation with the manuscript co-authors. The decision to submit the paper for publication was made by all co-authors.
Funding Information:
Dr. Keefe wrote the first draft of the paper. All other authors edited and commented on versions of the manuscript and approved the final version. This study was designed and supported by Drs. Loebel, Cucchiaro, and others at Dainippon Sumitomo Pharma America, now Sunovion. NeuroCog Trials trained the cognitive testers and conducted data quality review under the supervision of Drs Fox and Keefe. Analyses were completed by Dr. Cynthia Sui in consultation with the manuscript co-authors. Dr. Harvey consulted on the design of the study.
Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2011/2
Y1 - 2011/2
N2 - Objective: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Project produced a battery of tests, the MATRICS Consensus Cognitive Battery (MCCB), designed to assess cognitive treatment effects in clinical trials of patients with schizophrenia. In validation studies, the MCCB demonstrated excellent reliability, minimal practice effects and significant correlations with measures of functional capacity. This study addresses whether the MCCB demonstrates these favorable characteristics when administered in the context of the type of large multi-site industry trial for which it was designed. Methods: In a clinical trial comparing risperidone and lurasidone, 323 clinically-stable outpatients with schizophrenia at 29 sites were assessed with MCCB at screening and a median of 15. days later at baseline. A measure of functional capacity, the UCSD Performance-based Skills Assessment - Brief (UPSA-B) was administered at baseline. Results: All 323 (100%) patients had sufficient data for computing a composite score according to the MCCB criteria. The test-retest reliability of the MCCB composite score was excellent (ICC. = 0.88). The severity of cognitive impairment was T = 24.7 (SD. = 12.1) at screening and T = 26.7 (SD. = 12.4) at baseline. The MCCB composite score demonstrated a large correlation with the UPSA-B composite score (r = 60, df = 304, p< .001). The practice effect on the composite score was small (z = 0.18). Discussion: In the context of a 29-site antipsychotic trial in stable outpatients with schizophrenia, the MCCB is sensitive to cognitive deficits in all domains, demonstrates excellent test-retest reliability and small practice effects, and is strongly correlated with a leading measure of functional capacity.
AB - Objective: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Project produced a battery of tests, the MATRICS Consensus Cognitive Battery (MCCB), designed to assess cognitive treatment effects in clinical trials of patients with schizophrenia. In validation studies, the MCCB demonstrated excellent reliability, minimal practice effects and significant correlations with measures of functional capacity. This study addresses whether the MCCB demonstrates these favorable characteristics when administered in the context of the type of large multi-site industry trial for which it was designed. Methods: In a clinical trial comparing risperidone and lurasidone, 323 clinically-stable outpatients with schizophrenia at 29 sites were assessed with MCCB at screening and a median of 15. days later at baseline. A measure of functional capacity, the UCSD Performance-based Skills Assessment - Brief (UPSA-B) was administered at baseline. Results: All 323 (100%) patients had sufficient data for computing a composite score according to the MCCB criteria. The test-retest reliability of the MCCB composite score was excellent (ICC. = 0.88). The severity of cognitive impairment was T = 24.7 (SD. = 12.1) at screening and T = 26.7 (SD. = 12.4) at baseline. The MCCB composite score demonstrated a large correlation with the UPSA-B composite score (r = 60, df = 304, p< .001). The practice effect on the composite score was small (z = 0.18). Discussion: In the context of a 29-site antipsychotic trial in stable outpatients with schizophrenia, the MCCB is sensitive to cognitive deficits in all domains, demonstrates excellent test-retest reliability and small practice effects, and is strongly correlated with a leading measure of functional capacity.
KW - Clinical trials
KW - Cognition
KW - MCCB
KW - Neuropsychology
KW - Reliability
KW - Schizophrenia
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U2 - 10.1016/j.schres.2010.09.015
DO - 10.1016/j.schres.2010.09.015
M3 - Article
C2 - 21075600
AN - SCOPUS:78951492158
VL - 125
SP - 161
EP - 168
JO - Schizophrenia Research
JF - Schizophrenia Research
SN - 0920-9964
IS - 2-3
ER -