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- Title
Methodological issues in negative symptom trials.
- Authors
Marder, Stephen R; Daniel, David G; Alphs, Larry; Awad, A George; Keefe, Richard S E
- 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.
- Publication
Schizophrenia bulletin, 2011, Vol 37, Issue 2, p250
- ISSN
1745-1701
- Publication type
Journal Article
- DOI
10.1093/schbul/sbq161