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Publications [#273498] of Richard S. Keefe

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Journal Articles

  1. Marder, SR; Daniel, DG; Alphs, L; Awad, AG; Keefe, RSE (2011). Methodological issues in negative symptom trials.. Schizophrenia Bulletin, 37(2), 250-254. [doi]
    (last updated on 2019/04/21)

    Abstract:
    Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration trial; the optimal design of a study of a broad-spectrum agent that treats both positive and negative symptoms or a co-medication that is added to an antipsychotic; the relative strengths and weaknesses of available instruments for measuring negative symptoms; the definition of clinically meaningful improvement for these trials; and whether drugs can be approved for a subdomain of negative symptoms.


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