title: Methodological issues associated with preclinical drug development and increased placebo effects in schizophrenia clinical trials.
abstract: Recent failures to detect efficacy in clinical trials investigating pharmacological treatments for schizophrenia raise concerns regarding the potential contribution of methodological shortcomings to this research. This review provides an examination of two key methodological issues currently suspected of playing a role in hampering schizophrenia drug development; 1) limitations on the translational utility of preclinical development models, and 2) methodological challenges posed by increased placebo effects. Recommendations for strategies to address these methodological issues are addressed.
authors.affiliation: a Department of Psychiatry , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
authors.forename: Matt A
authors.initials: MA
authors.lastname: Brown
authors.affiliation: a Department of Psychiatry , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
authors.forename: Ram J
authors.initials: RJ
authors.lastname: Bishnoi
authors.affiliation: a Department of Psychiatry , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
authors.forename: Sara
authors.initials: S
authors.lastname: Dholakia
authors.affiliation: a Department of Psychiatry , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
authors.forename: Dawn I
authors.initials: DI
authors.lastname: Velligan
keywords: clinical trials; drug development; methodological issues; pharmacology; placebo effect; preclinical; schizophrenia; treatment efficacy