Cited by 154Schizophrenia research and treatmentStatistical Methods in Clinical TrialsDementia and Cognitive Impairment Research

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The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?

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Buchanan, R. W., Keefe, R. S. E., Umbricht, D., Green, M. F., Laughren, T., Marder, S. R.·2011·Schizophrenia Bulletin

DOI 10.1093/schbul/sbq038PMC PMC3196938

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Abstract

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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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.
ORCID: Buchanan, R. W.
Keefe, R. S. E.
Umbricht, D.
Green, M. F.
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
DOI: 10.1093/schbul/sbq038
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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The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?

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