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- W2105454368 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." @default.
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- W2105454368 date "2005-01-01" @default.
- W2105454368 modified "2023-10-03" @default.
- W2105454368 title "A Summary of the FDA-NIMH-MATRICS Workshop on Clinical Trial Design for Neurocognitive Drugs for Schizophrenia" @default.
- W2105454368 cites W1142017 @default.
- W2105454368 cites W1587844214 @default.
- W2105454368 cites W1616286551 @default.
- W2105454368 cites W1702878397 @default.
- W2105454368 cites W1832450836 @default.
- W2105454368 cites W1966032811 @default.
- W2105454368 cites W1968080961 @default.
- W2105454368 cites W1968749106 @default.
- W2105454368 cites W1970771699 @default.
- W2105454368 cites W1975092497 @default.
- W2105454368 cites W1980676990 @default.
- W2105454368 cites W1980980884 @default.
- W2105454368 cites W1981794565 @default.
- W2105454368 cites W1983805722 @default.
- W2105454368 cites W1984145895 @default.
- W2105454368 cites W1985517071 @default.
- W2105454368 cites W1985687796 @default.
- W2105454368 cites W1994048538 @default.
- W2105454368 cites W1999465712 @default.
- W2105454368 cites W2004050634 @default.
- W2105454368 cites W2007980588 @default.
- W2105454368 cites W2009485462 @default.
- W2105454368 cites W2010163426 @default.
- W2105454368 cites W2010407531 @default.
- W2105454368 cites W2018642809 @default.
- W2105454368 cites W2021799665 @default.
- W2105454368 cites W2022180773 @default.
- W2105454368 cites W2022765281 @default.
- W2105454368 cites W2028963546 @default.
- W2105454368 cites W2031520532 @default.
- W2105454368 cites W2032586089 @default.
- W2105454368 cites W2035528776 @default.
- W2105454368 cites W2035788257 @default.
- W2105454368 cites W2037232426 @default.
- W2105454368 cites W2037491528 @default.
- W2105454368 cites W2040612030 @default.
- W2105454368 cites W2042407610 @default.
- W2105454368 cites W2042605537 @default.
- W2105454368 cites W2042952846 @default.
- W2105454368 cites W2045844074 @default.
- W2105454368 cites W2048517803 @default.
- W2105454368 cites W2049770520 @default.
- W2105454368 cites W2051812300 @default.
- W2105454368 cites W2051817607 @default.
- W2105454368 cites W2052302319 @default.
- W2105454368 cites W2054209782 @default.
- W2105454368 cites W2055482170 @default.
- W2105454368 cites W2055509010 @default.
- W2105454368 cites W2056212570 @default.
- W2105454368 cites W2067786055 @default.
- W2105454368 cites W2071245800 @default.
- W2105454368 cites W2075453825 @default.
- W2105454368 cites W2075578206 @default.
- W2105454368 cites W2077822166 @default.
- W2105454368 cites W2078790185 @default.
- W2105454368 cites W2082246284 @default.
- W2105454368 cites W2083252023 @default.
- W2105454368 cites W2084220664 @default.
- W2105454368 cites W2090568328 @default.
- W2105454368 cites W2090874551 @default.
- W2105454368 cites W2093754907 @default.
- W2105454368 cites W2094188000 @default.
- W2105454368 cites W2099556941 @default.
- W2105454368 cites W2106013922 @default.
- W2105454368 cites W2111410851 @default.
- W2105454368 cites W2115821201 @default.
- W2105454368 cites W2118189281 @default.
- W2105454368 cites W2127795200 @default.
- W2105454368 cites W2128164348 @default.
- W2105454368 cites W2133700875 @default.
- W2105454368 cites W2143830678 @default.
- W2105454368 cites W2145453003 @default.
- W2105454368 cites W2145816995 @default.
- W2105454368 cites W2149805979 @default.
- W2105454368 cites W2154702901 @default.
- W2105454368 cites W2161414087 @default.
- W2105454368 cites W2161760321 @default.
- W2105454368 cites W2168191159 @default.
- W2105454368 cites W2168814349 @default.
- W2105454368 cites W2313574000 @default.
- W2105454368 cites W2324392187 @default.