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Schizophr Bull. 2011 Mar;37(2):250-4. doi: 10.1093/schbul/sbq161. Epub 2011 Jan 26.

Methodological issues in negative symptom trials.

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  • 1The Semel Institute for Neuroscience at University of California, Los Angeles, CA, USA.marder@ucla.edu

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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PMID:
21270473
[PubMed - indexed for MEDLINE]
PMCID:
PMC3044631
Free PMC Article
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