The DOI matches its Crossref record; 38 of the 38 references it cites were found in a registry or an index.
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“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]
In the citing paper
“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]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
What are the functional consequences of neurocognitive deficits in schizophrenia?
(1996) · American Journal of Psychiatry · doi:10.1176/ajp.153.3.321 · Cited by 3,516
Self-citationThe MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity
Nuechterlein, K. H., Green, M. F., Kern, R. S., Baade, L. E., Barch, D. M., Cohen, J. D., Essock, S., Fenton, W. S., Frese, F. J., Gold, J. M., et al. (2008) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2007.07010042 · Cited by 2,342
Self-citationLongitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS
Green, M. F., Kern, R. S., & Heaton, R. K. (2004) · Schizophrenia Research · doi:10.1016/j.schres.2004.09.009 · Cited by 1,422
Self-citationKeefe, R. S. E. (2007) · Archives of General Psychiatry · doi:10.1001/archpsyc.64.6.633 · Cited by 1,096
Self-citationKahn, R. S., Fleischhacker, W. W., Boter, H., Davidson, M., Vergouwe, Y., Keet, I. P., Gheorghe, M. D., Rybakowski, J. K., Galderisi, S., Libiger, J., et al. (2008) · The Lancet · doi:10.1016/s0140-6736(08)60486-9 · Cited by 1,088
Green, M. F., Nuechterlein, K. H., Gold, J. M., Barch, D. M., Cohen, J., Essock, S., Fenton, W. S., Frese, F., Goldberg, T. E., Heaton, R. K., et al. (2004) · Biological Psychiatry · doi:10.1016/j.biopsych.2004.06.023 · Cited by 919
Self-citationMilev, P., Ho, B., Arndt, S. V., & Andreasen, N. C. (2005) · American Journal of Psychiatry · doi:10.1176/appi.ajp.162.3.495 · Cited by 919
The MATRICS Consensus Cognitive Battery, part 2: co-norming and standardization
Kern, R. S., Nuechterlein, K. H., Green, M. F., Baade, L. E., Fenton, W. S., Gold, J. M., Keefe, R. S. E., Mesholam-Gately, R., Mintz, J., Seidman, L. J., et al. (2008) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2007.07010043 · Cited by 744
Self-citationPatterson, T., Goldman, S., McKibbin, C. L., Hughs, T., & Jeste, D. V. (2001) · Schizophrenia Bulletin · doi:10.1093/oxfordjournals.schbul.a006870 · Cited by 740
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
Self-citation
Research works printed but not linked: 2
- 2009, Schizophrenia Bulletin, 35, 358
- Bellack, 1994, Journal of abnormal psychology, 103, 371, 10.1037/0021-843X.103.2.371 · DOI
Cited by
Sorted by citations
Items 101–154 of 154
Horan, W. P., Kalali, A. H., Brannan, S. K., Drevets, W., Leoni, M. J., Mahableshwarkar, A. R., Martin, W. J., Rao, S., Reuteman-Fowler, C., Sauder, C. L., et al. (2025) · Schizophrenia Bulletin · doi:10.1093/schbul/sbae151 · Cited by 12
Functional Outcome in Patients With Schizophrenia: The Concept and Measurement
Sumiyoshi, C., & Sumiyoshi, T. (2015) · Activitas Nervosa Superior · doi:10.1007/bf03379619 · Cited by 11
Minzenberg, M., Yoon, J. H., Soosman, S. K., & Carter, C. S. (2018) · Translational Psychiatry · doi:10.1038/s41398-018-0104-z · Cited by 10
Cognition in schizophrenia: Summary Nice Consultation Meeting 2012
Nutt, D., Wied, C. C. G., Arango, C., Keefe, R. S. E., Penadés, R., Murphy, D., Robbins, T. W., & Sahakian, B. J. (2013) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2013.03.005 · Cited by 9
Self-citationGreek, R., & Hansen, L. A. (2012) · Biological Systems Open Access · doi:10.4172/2329-6577.1000109 · Cited by 10
Horan, W. P., Depp, C. A., Hurst, S., Linthicum, J., Vargas, G. S., Klein, H., Keefe, R. S. E., & Harvey, P. D. (2023) · Schizophrenia Bulletin Open · doi:10.1093/schizbullopen/sgad012 · Cited by 8
Self-citationJavitt, D. C. (2025) · American Journal of Psychiatry · doi:10.1176/appi.ajp.20241187 · Cited by 7
Tcheremissine, O. V., Castro, M. A., & Gardner, D. R. (2011) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.2012.634798 · Cited by 6
Cuesta, M. J., Sánchez-Torres, A. M., Lorente-Omeñaca, R., Zandio, M., Moreno-Izco, L., & Peralta, V. (2020) · Psychiatry Research · doi:10.1016/j.psychres.2020.113404 · Cited by 6
Development of a Virtual Reality Assessment of Everyday Living Skills
Ruse, S. A., Davis, V. G., Atkins, A. S., Krishnan, K. R. R., Fox, K. H., Harvey, P. D., & Keefe, R. S. E. (2014) · Journal of Visualized Experiments · doi:10.3791/51405-v · Cited by 6
Self-citationGuzman, A., Klein, H., Keefe, R. S. E., Horan, W. P., & Harvey, P. D. (2024) · Psychiatry Research · doi:10.1016/j.psychres.2024.116121 · Cited by 5
Self-citationMethods for Delivering and Evaluating the Efficacy of Cognitive Enhancement
Harvey, P. D., & Keefe, R. S. E. (2015) · Handbook of experimental pharmacology · doi:10.1007/978-3-319-16522-6_1 · Cited by 5
Self-citationPezzella, P., Caporusso, E., Mucci, A., Bucci, P., Giordano, G. M., Amore, M., Rocca, P., Rossi, A., Bertolino, A., Ventura, J., et al. (2024) · Schizophrenia Bulletin Open · doi:10.1093/schizbullopen/sgae020 · Cited by 5
Reducing off‐label prescribing in psychiatry
Hickie, I. B. (2014) · The Medical Journal of Australia · doi:10.5694/mja14.00050 · Cited by 5
Kraus, M., Gold, J. M., Barch, D. M., Walker, T. M., Chun, C. A., Buchanan, R. W., Csernansky, J. G., GOFF, D. C., Green, M. F., Jarskog, L. F., et al. (2019) · Schizophrenia Research Cognition · doi:10.1016/j.scog.2019.100161 · Cited by 4
Self-citationLenderking, W. R., Atkinson, M. J., Ladd, M. K., Savva, Y., Sommer, S., Sidovar, M. F., & Hastedt, C. (2024) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-024-00731-x · Cited by 3
Tan, Y., Zong, X., Li, H., Feng, M., He, J., Sun, X., Zhang, Y., Wang, X., Yao, J. J., & Hu, M. (2025) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2025.1675079 · Cited by 3
Greek, R. (2014) · Biological Systems Open Access · doi:10.4172/2329-6577.1000124 · Cited by 3
HEINSSEN, R. K., Morris, S. E., & Sherrill, J. T. (2024) · Schizophrenia Bulletin · doi:10.1093/schbul/sbae109 · Cited by 4
Consenso argentino sobre diagnóstico y tratamiento de la esquizofrenia resistente al tratamiento
Corral, R. M. (2021) · Vertex Revista Argentina de Psiquiatría · doi:10.53680/vertex.v32i154.119 · Cited by 13
Molina, J. D. D., Quintero, J., García-Laredo, E., Lopez-Munoz, F. J., Correas-Lauffer, J., Barbudo, E., Ceverino, A., Mur, C., & Garcı́a-Resa, E. (2019) · American Journal of Therapeutics · doi:10.1097/mjt.0000000000000956 · Cited by 3
Miyamoto, S., Merrill, D. B., Jarskog, L. F., Fleishhacker, W. W., Marder, S. R., & Lieberman, J. A. (2015) · Wiley eBooks · doi:10.1002/9781118753378.ch104 · Cited by 4
Self-citationTulliez, S., Karantzoulis, S., Marcus, J. C., Casamayor, M., Blanchard, C., Goenjian, H. A., Kantrowitz, J. T., Shirikjian, L., Sonnenberg, J. G., Reuteman-Fowler, C., et al. (2025) · Schizophrenia · doi:10.1038/s41537-025-00619-9 · Cited by 2
Self-citationHarvey, P. D., Keefe, R. S. E., Kallestrup, P., Czaja, S. J., Klein, H., & Horan, W. P. (2024) · Schizophrenia Research Cognition · doi:10.1016/j.scog.2024.100331 · Cited by 2
Self-citationPharmacological approaches to cognitive enhancement
Harvey, P. D. (2013) · Cambridge University Press eBooks · doi:10.1017/cbo9781139003872.016 · Cited by 2
Neuropsychological Assessment and Neurophysiological Evaluation
Giuliano, A. J., Bruder, G. E., & Seidman, L. J. (2015) · Wiley eBooks · doi:10.1002/9781118753378.ch37 · Cited by 2
Yang, L., Tang, Y., Zhu, J., Xu, L., Wang, M., Sun, W., & Shi, C. (2025) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s497602 · Cited by 1
Ganesh, A., Sujanthan, S., Muir, R. T., Joundi, R. A., Hill, M. D., Quinn, T. J., Menon, B. K., Sajobi, T. T., Rabin, J. S., Dainty, K. N., et al. (2026) · Circulation · doi:10.1161/circulationaha.125.077180 · Cited by 1
Schmidt, S. J., & Roder, V. (2015) · Springer eBooks · doi:10.1007/978-3-319-13245-7_1 · Cited by 1
Neuropsychological and Neurophysiological Assessment
Fiorillo, A., Sokhadze, E. M., & Sampogna, G. (2023) · Springer eBooks · doi:10.1007/978-3-030-42825-9_114-1 · Cited by 1
Neuropsychological and Neurophysiological Assessment
Fiorillo, A., Sokhadze, E. M., & Sampogna, G. (2024) · Springer eBooks · doi:10.1007/978-3-030-51366-5_114 · Cited by 2
Modality Shift Effect in Psychiatric Disorders – a New Look at an Old Paradigm
Krag, P. J., Licht, R. W., & Nielsen, R. E. (2016) · European Psychiatry · doi:10.1016/j.eurpsy.2016.08.010 · Cited by 1
LAUGHREN, T. P. (2013) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2013.04.007 · Cited by 1
Self-citationPerformance-based measures of functioning in schizophrenia
Depp, C. A., de Dios, L. V., Mausbach, B. T., & Patterson, T. L. (2013) · Cambridge University Press eBooks · doi:10.1017/cbo9781139003872.015
Assessment and treatment of cognitive impairment and related features
Harvey, P. D. (2013) · Cambridge University Press eBooks · doi:10.1017/cbo9781139003872.014
Der Einfluss des kognitiven Status schizophren Erkrankter auf Zielkriterien der Psychoedukation
Wrege, J. S. (2015) · Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver · doi:10.17169/refubium-5311
Effects of add-on mirtazapine on neurocognition in schizophrenia
Stenberg, J. (2014) · Työväentutkimus Vuosikirja
Time to Re-focus onto Cognitive Symptoms in Schizophrenia
Reddy, M. S. S., & Mythri, S. V. (2016) · Indian Journal of Psychological Medicine · doi:10.4103/0253-7176.178765
Harvey, P. D., & Keefe, R. S. E. (2012) · Cambridge University Press eBooks · doi:10.1017/cbo9780511977640.013
Self-citationLeppert, R. (2011) · eDiss (Georg-August-Universität Göttingen) · doi:10.53846/goediss-953
Translational behavioral research using common marmosets in the psychiatric field
Enomoto, T., & Ikeda, K. (2019) · Folia Pharmacologica Japonica · doi:10.1254/fpj.153.28
Full recovery in first-episode schizophrenia: Long-term cognitive functioning and functional outcome
Fu, S. (2019) · NORA - Norwegian Open Research Archives
Mental Health Retrosight: Perspectives
Pollitt, A., Diepeveen, S., Guthrie, S., Horvitz-Lennon, M. V., Jones, M. M., Chonaill, S. N., Schultz, D. J., Pincus, H. A., Grant, J., & Wooding, S. (2013) · RAND Corporation eBooks · doi:10.7249/rr451
Sarno, E. S. D. (2020) · Digital Library of Theses and Dissertations (Universidade de São Paulo) · doi:10.11606/d.5.2020.tde-16062021-140712
Schmidt, S. J., & Roder, V. (2015) · Springer eBooks · doi:10.1007/978-88-470-5735-7_1
Roder, V., & Schmidt, S. J. (2013) · Springer eBooks · doi:10.1007/978-3-642-21440-0_1
Okusaga, O. O., Vijayan, K. V., & Rumbaut, R. E. (2023) · medRxiv · doi:10.1101/2023.01.10.23284409
Dondé, C., Bastin, J., Pouchon, A., Costes, N., Fakra, E., Galvao, F., Gay, A., Haesebaert, F., Lamalle, L., Mérida, I., et al. (2023) · Trials · doi:10.1186/s13063-023-07160-z
Neuropsychological and Functional Assessment of Cognitive Impairments in Schizophrenia
Recio-Barbero, M., Losada-León, N., Mentxaka, O., Cabezas-Garduño, J., & Segarra, R. (2023) · Methods in molecular biology · doi:10.1007/978-1-0716-3307-6_10
Evolving Concepts for the Assessment and Treatment of Schizophrenia
Giordano, G. M., Pezzella, P., Gäebel, W., & Galderisi, S. (2024) · Cambridge University Press eBooks · doi:10.1017/9781009067287.015
Petersen, J. Z., Kjærstad, H. L., Porten, M. N., Kessing, L. V., & Miskowiak, K. W. (2025) · Bipolar Disorders · doi:10.1111/bdi.70051 · Cited by 1
Dondé, C., Bastin, J., Pouchon, A., Costes, N., Fakra, É., Galvão, F., Gay, A., Haesebaert, F., Lamalle, L., Mérida, I., et al. (2023) · Figshare · doi:10.6084/m9.figshare.22610681
Pharmacological Treatment of Cognitive Impairment in Schizophrenia
Neff, M. A., & Harvey, P. D. (2025) · Comprehensive approach to psychiatry · doi:10.1007/978-3-032-06209-3_12
Tyburski, E. M., Zawadzka, E., Bober, A., Karabanowicz, E., Podwalski, P., Samochowiec, J., Michalczyk, A., Mueller, S. T., Szelepajło, M., Misiak, B., et al. (2026) · Scientific Reports · doi:10.1038/s41598-026-40643-y
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
