The first phase of the Cognitive Neuroscience Treatment Research to Improve Cognition
in Schizophrenia (CNTRICs) initiative focused on the identification of cognitive constructs
from human and animal neuroscience that were relevant to understanding cognitive deficits
in schizophrenia, as well as promising task paradigms that could be used to assess
these constructs behaviorally. The current phase of CNTRICs has the goal of expanding
this initial work by including measures of brain function that can augment these behavioral
tasks as biomarkers to be used in drug development processing. Here we review many
of the psychometric issues that need to be addressed regarding the development and
inclusion of such methods in the drug development process. In addition, we review
quality assurance concerns, issues associated with multicenter trials, concerns associated
with potential pharmacologic confounds on imaging measures, as well as power and analysis
considerations. Although review is couched in the context of the use of biomarkers
for treatment studies in schizophrenia, we believe the issues and suggestions included
are relevant to the entire range of neuropsychiatric disorders as well as to a wide
range of imaging modalities (i.e., functional magnetic resonance imaging, positron
emission tomography, event-related potentials, electroencephalography, transcranial
magnetic stimulation, near infrared spectroscopy, etc.) and are relevant to both pharmacologic
and psychological intervention approaches.
Key Words
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Article info
Publication history
Published online: February 22, 2011
Accepted:
January 6,
2011
Received in revised form:
January 5,
2011
Received:
September 26,
2010
Identification
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© 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
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- Standardization, Integration, and Sharing—Leveraging Research InvestmentsBiological PsychiatryVol. 70Issue 1
- PreviewCognitive impairment has been recognized as a significant cause of disability in schizophrenia for more than 20 years (1,2), but the development of effective treatments for cognitive impairment in schizophrenia has been slow to advance. The National Institute of Mental Health (NIMH) Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative (3) brought together members of academia, the pharmaceutical industry, and the US Food and Drug Administration to increase the viability of drug development by establishing consensus guidelines for study methodology, identifying promising targets for further investigation, and developing a standardized cognitive battery for use as end points in clinical trials.
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