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Activity Number:
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515
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Type:
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Contributed
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Date/Time:
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Thursday, August 10, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305619 |
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Title:
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Is There an Optimal Sample in Depression Studies?
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Author(s):
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Kenneth Liu*+ and Duane Snavely
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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BL 3 2, West Point, PA, 19486,
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Keywords:
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sample size ; patient drift ; clinical trials
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Abstract:
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Four parallel-group, placebo-controlled phase III studies were conducted to evaluate the antidepressant effect of a test compound compared to placebo; an approved antidepressant, paroxetine, was included as an active control. Paroxetine consistently outperformed placebo in reducing the 17-item total of the Hamilton Depression Rating Scale after eight weeks of treatment. During the design of these studies, questions existed as to whether there may be a "negative" return on investment with respect to the sample sizes; that is, larger sample sizes may not necessarily increase the chance for a positive study due to patient drift. The results of a post-hoc analysis will be discussed.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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