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The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?
Open accessAbstract
The Food and Drug Administration (FDA)-National Institute of Mental Health (NIMH)-Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) clinical trial guidelines for cognitive-enhancing drugs in schizophrenia and the MATRICS Consensus Cognitive Battery (MCCB) were designed to facilitate novel compound development in the treatment of cognitive impairments. Several studies have recently utilized the FDA-NIMH-MATRICS guidelines and MCCB and allow an evaluation of the feasibility of guideline implementation and MCCB performance. In light of the study results, we would recommend the following inclusion criteria revisions-(1) clinical status and symptom inclusion criteria: maximum allowed score for hallucinations and delusions should be increased from moderate to moderately severe and the negative symptom criterion should be dropped in phase 2 studies; (2) antipsychotic medication inclusion criteria: first-generation antipsychotics should be allowed, but only in the context of no concomitant anticholinergic agents and minimal extrapyramidal symptoms, and antipsychotic polypharmacy should be allowed in the absence of pertinent pharmacokinetic or pharmacodynamic considerations; and (3) people who use illicit substances should not be allowed in phase 1B or 2A proof-of-concept studies but may be included in phase 2B and 3 studies in which proof of effectiveness and generalizability of results become more important goals. These revisions are recommended to enhance recruitment while maintaining sufficient methodological rigor to ensure the validity of study results. The MCCB has been shown to have excellent psychometric characteristics, including reliability for multisite clinical trials, clinical relevance for real-world functioning, and possible sensitivity to behavioral treatment, and should continue to serve as the standard outcome measure for cognitive enhancement studies in schizophrenia.
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“Based on experience from early studies that used the MATRICS clinical trial guidelines, the MATRICS investigators recommended revision of the inclusion criteria to enhance recruitment while maintaining sufficient methodological rigor.20”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [20]
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“The original MATRICS guidelines17 specify that a phase 3 registration trial should be of sufficient duration to show an enduring effect on cognition (ie, at least 6 months), and this recommendation remained unchanged in their recent revision.20”
From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [20]
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Self-citationThe MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity
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Self-citationLongitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS
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The MATRICS Consensus Cognitive Battery, part 2: co-norming and standardization
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A Separate Disease Within the Syndrome of Schizophrenia
Kirkpatrick, B. W., Buchanan, R. W., Ross, D. E., & Carpenter, W. T. (2001) · Archives of General Psychiatry · doi:10.1001/archpsyc.58.2.165 · Cited by 651
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Millan, M. J., Agid, Y., Brüne, M., Bullmore, E. T., Carter, C. S., Clayton, N. S., Connor, R., Davis, S., Deakin, B., DeRubeis, R. J., et al. (2012) · Nature Reviews Drug Discovery · doi:10.1038/nrd3628 · Cited by 1,292
Cognitive Impairment in Schizophrenia
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Self-citationTargeting the correct HDAC(s) to treat cognitive disorders
Fischer, A., Sananbenesi, F., Mungenast, A. E., & Tsai, L. (2010) · Trends in Pharmacological Sciences · doi:10.1016/j.tips.2010.09.003 · Cited by 365
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Social Cognition Psychometric Evaluation: Results of the Initial Psychometric Study
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Metadata
- Authors
- Buchanan, R. W., Keefe, R. S. E., Umbricht, D., Green, M. F., Laughren, T., & Marder, S. R.
- Affiliations
- University of Maryland, Baltimore (US)
- Duke Medical Center (US)
- F. Hoffmann-La Roche AG (CH)
- University of California, Los Angeles (US)
- United States Food and Drug Administration (US)
- Corresponding author
- Buchanan, R. W.
- Venue
- Schizophrenia Bulletin
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-04-21
- Volume
- 37
- Issue
- 6
- Pages
- 1209-1217
- ISSN
- 0586-7614 (ISSN-L)
- 1745-1701
- PMC
- PMC3196938
- OpenAlex
- W2126154566
- Cited by
- 154
- References
- 38
- Citations by year
- 2026: 2 · 2025: 8 · 2024: 10 · 2023: 8 · 2022: 4 · 2021: 6 · 2020: 6 · 2019: 10 · 2018: 7 · 2017: 4 · 2016: 11 · 2015: 19 · 2014: 14 · 2013: 20 · 2012: 10
- FWCI
- 9.84
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Schizophrenia Bulletin (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Abbott Laboratories
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- GlaxoSmithKline
- Sanofi
- CHDI Foundation
- F. Hoffmann-La Roche
- Dainippon Sumitomo Pharma
- H. Lundbeck A/S
- National Institutes of Health (n01mh022006-001)
- U.S. Public Health Service (HHSN278 200441003C)
- National Institute of Mental Health (MH22006)
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Keywords
- nootropic drugs
- MeSH terms
- Adult, Clinical Trials as Topic, Cognition, Humans, National Institute of Mental Health (U.S.), Neuropsychological Tests, Research Design, Schizophrenia, Schizophrenic Psychology, Antipsychotic Agents, United States, United States Food and Drug Administration, Guidelines as Topic, Nootropic Agents
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