JSM 2005 - Toronto

Abstract #302648

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 80
Type: Invited
Date/Time: Monday, August 8, 2005 : 8:30 AM to 10:20 AM
Sponsor: Section on Health Policy Statistics
Abstract - #302648
Title: Quantifying Placebo Effect in Discontinuation Trials
Author(s): Eva Petkova*+ and Thaddeus Tarpey
Companies: Columbia University and Wright State University
Address: 1051 Riverside Drive, New York, NY, 10032,
Keywords: antidepressants ; true drug response ; placebo response ; functional data ; survival analysis ; partitioning
Abstract:

An important problem in clinical practice and research is identifying and differentiating placebo from a true drug effect. A method for distinguishing between true drug and placebo response profiles in antidepressant clinical trials has been proposed (Tarpey et al. 2003). Discontinuation studies will be used to validate that method. Discontinuation trials are designed to determine the appropriate length of drug maintenance for depressed subjects who have responded to initial treatment with a drug. Responders to acute treatment are randomized to continue the medication or are switched to placebo and time to relapse is assessed. The premise is that subjects who respond to the active drug will have different relapse rates depending on whether they are maintained on the drug or are switched to placebo, whereas the relapse of placebo responders will not differentiate between the two. The analysis jointly models symptoms' severity during the acute treatment and the discontinuation phases. This is accomplished by treating the estimated coefficients from the functional profiles as continuous covariates in the survival models.

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Revised March 2005