Methodological issues in negative symptom trials.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Marder, SR; Daniel, DG; Alphs, L; Awad, AG; Keefe, RSE

Published Date

  • March 2011

Published In

Volume / Issue

  • 37 / 2

Start / End Page

  • 250 - 254

PubMed ID

  • 21270473

Pubmed Central ID

  • 21270473

Electronic International Standard Serial Number (EISSN)

  • 1745-1701

International Standard Serial Number (ISSN)

  • 1787-9965

Digital Object Identifier (DOI)

  • 10.1093/schbul/sbq161

Language

  • eng