Table of Contents
Sertraline for PTSD: NDA 19-839 David Smith, Ph.D. Statistical Reviewer Office of Biostatistics U.S. Food and Drug Admin. 8 October 1999
Proposed Indication Sertraline is indicated for the treatment of post-traumatic stress disorder (PTSD).
Issues for consideration
Demographic Characteristics
Mean Changes from Baseline Primary PTSD Instruments NB: Large negative changes imply patient benefit
Relevance of 641 & 682
Gender Differences
Handling subgroup analyses
PPT Slide
Depression and PTSD
Question: Can we measure PTSD improvement in the presence of an antidepressive effect?
Dep. Improvement (Analysis #1) HAM-D Total
PTSD diffs by HAM-D Subgroups (Analysis #1) NB: Results are inclusive of both treatments
“Depressed Mood” (Analysis #2) HAM-D Ques. 1 Sadness, hopeless, helpless, worthless
HAM-D Q1 Improvement (#2) Depressed Mood
PPT Slide
Women in 640 / 671 (#2 Cont.)
PPT Slide
PPT Slide
PPT Slide
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Author: CDER User
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