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Cited by 438Schizophrenia research and treatmentStatistical Methods in Clinical TrialsPharmaceutical studies and practices

A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia

Buchanan, R. W·2005·Schizophrenia Bulletin
DOI 10.1093/schbul/sbi020
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Abstract

OBJECTIVE: On April 23, 2004, a joint meeting of the FDA, NIMH, MATRICS investigators, and experts from academia and the pharmaceutical industry was convened to develop guidelines for the design of clinical trials of cognitive-enhancing drugs for neurocognitive impairments in patients with schizophrenia. METHOD: Experts were asked to address specific questions relating to clinical trial design of adjunctive/co-treatment and broad spectrum agents. At the workshop, experts reviewed relevant evidence before offering the discussion panel proposed guidelines for a given subset of questions. The discussion panel, which consisted of presenters and representatives from FDA, NIMH, academia, and industry, deliberated to reach consensus on suggested guidelines. When evidence was insufficient, suggested guidelines represent the opinion of a cross-section of the presenters and discussion panel. RESULTS: Guidelines were developed for inclusion criteria, the use of co-primary outcome measures, and statistical approaches for study design. Consensus was achieved regarding diagnostic and concomitant medication inclusion criteria and on the use of cognitive screening measures. A key guideline was to limit the trial to patients in the residual phase of their illness, who have a predefined level of positive, negative, and affective symptoms. The most difficult issues were the feasibility of including a co-primary measure of functional improvement and the choice of comparator agent for a trial of a broad spectrum agent (with antipsychotic and cognitive-enhancing effects). CONCLUSIONS: The suggested guidelines represent reasonable starting points for trial design of cognitive-enhancing drugs, with the understanding that new data, subsequent findings, or other methodological considerations may lead to future modifications.

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  • The MATRICS initiative facilitated the development of guidelines for the design of clinical trials of drugs for neurocognitive impairment in schizophrenia.

    “The joint academic, government, and industry Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative facilitated the development of guidelines for the design of clinical trials of drugs for neurocognitive impairment in schizophrenia17”

    From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [17]

  • A randomized, double-blind placebo-controlled add-on design was recommended by the MATRICS panel.

    “A randomized, double-blind placebo-controlled add-on design was recommended by the MATRICS panel17”

    From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [17]

  • A majority of completed and ongoing trials follow the MATRICS guidelines for studying an adjunctive/cotreatment agent in a randomized, placebo-controlled trial consisting of clinically stable participants with schizophrenia.

    “In general, a majority of completed and ongoing trials follow the MATRICS guidelines17 for studying an adjunctive/cotreatment agent in a randomized, placebo-controlled trial consisting of clinically stable participants with schizophrenia.17,51–53”

    From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [17]

  • The original MATRICS guidelines specify that a phase 3 registration trial should be of sufficient duration to show an enduring effect on cognition (at least 6 months).

    “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 [17]

  • The MATRICS guidelines noted that in general, it is not necessary to exclude subjects with a high level of cognitive functioning in whom further improvement in cognition would not be expected to be demonstrated because with a properly constructed cognitive test battery, this level of performance is very rare.

    “The MATRICS guidelines17 noted that in general, it is not necessary to exclude subjects with a high level of cognitive functioning in whom further improvement in cognition would not be expected to be demonstrated because with a properly constructed cognitive test battery, this level of performance is very rare.”

    From Clinical trials of potential cognitive-enhancing drugs in schizophrenia: what have we learned so far? (2013) · cites this paper as [17]

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Authors
Buchanan, R. W.
Corresponding author
Buchanan, R. W
ORCID
Buchanan, R. W
Venue
Schizophrenia Bulletin
Publisher
Oxford University Press (OUP)
Published
2005-01-01
Volume
31
Issue
1
Pages
5-19
ISSN
  • 0586-7614 (ISSN-L)
  • 1745-1707
DOI
10.1093/schbul/sbi020
OpenAlex
W2105454368
Cited by
438
References
90
Citations by year
2026: 5 · 2025: 11 · 2024: 7 · 2023: 8 · 2022: 8 · 2021: 9 · 2020: 11 · 2019: 13 · 2018: 14 · 2017: 16 · 2016: 24 · 2015: 27 · 2014: 33 · 2013: 32 · 2012: 24
FWCI
18.73
Type
journal article
Language
en
Open access
closed
Locations
  • Schizophrenia Bulletin (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (n01mh022006-001)
  • National Institute of Mental Health (MH22006)
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 › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords
schizophrenia, neurocognitive impairment
MeSH terms
Clinical Trials as Topic, Cognition Disorders, Combined Modality Therapy, Health Promotion, Humans, Mental Health Services, National Institute of Mental Health (U.S.), Brief Psychiatric Rating Scale, Psychotherapy, Schizophrenia, Severity of Illness Index, Antipsychotic Agents, United States, United States Food and Drug Administration, Treatment Outcome, Guidelines as Topic, Polypharmacy

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