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Proposal 1234

Title of the Proposed Research

Predictors of Placebo Response in Pediatric Patients with Generalized Anxiety Disorder

Lead Researcher

Jeffrey R. Strawn, MD

Affiliation

University of Cincinnati

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

25 August 2015

Lay Summary

High placebo-response rates have complicated the interpretation of medication studies in children with depression (Emslie, 2009; Bridge et al, 2009; March et al, 2012), ADHD (Newcorn et al, 2009) and anxiety disorders (Rynn et al, 2007). Recently, several studies have attempted to determine which patients respond to placebo (sugar pill) studies of teens with depression and ADHD (Newcorn et al, 2009). However, little is known regarding factors which may affect placebo response in studies of medications in adolescents with anxiety. In this regard, knowing which factors predict placebo response will help us design better studies. While we reported the placebo response rate in our publication from this study (Strawn et al, 2015), the factors which influenced this response have not been explored systematically.

Study Data Provided

Study LILLY-F1J-MC-HMGI: A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.