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Abstract Details

Activity Number: 657
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #304866
Title: Exploratory Efficacy Analyses for Antidepressant Clinical Trials Using Integrated Trial Data
Author(s): Yeh-Fong Chen*+ and Peiling Yang
Companies: FDA and FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD, 20993, United States
Keywords: Major Depression Disorder ; placebo response ; randomized withdrawal design
Abstract:

Major depression disorder (MDD) is an emerging disease that affected about 17% of the U.S. population. It is also a major cause of morbidity worldwide. Even though this disorder has been well studied and drug treatments are already available on the market, the average success rate of MDD trials is only about 50%. In addition, MDD patients are at the substantial risk of relapse and recurrence after discontinuation of antidepressant treatment. To improve the trial success rate for an effective new drug and to obtain critical information about drug's long-term efficacy, it is essential to examine the available clinical trials and to collect aggregate signals from these trials, including short-term and long-term trials.

In this talk, challenges in conducting successful MDD trials, such as trial design for dealing with high placebo response and randomized withdrawal design for assessing drugs' long-term efficacy, etc. will be illustrated with extensive discussions. Exploratory efficacy analysis results using trial data from FDA archived database will also be presented.


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