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Sertraline for PTSD: NDA 19-839David Smith, Ph.D. Statistical ReviewerOffice of BiostatisticsU.S. Food and Drug Admin.8 October 1999
Proposed IndicationSertraline is indicated for the treatment of post-traumatic stress disorder (PTSD).
Issues for consideration
Mean Changes from BaselinePrimary PTSD InstrumentsNB: Large negative changes imply patient benefit
Relevance of 641 & 682
Handling subgroup analyses
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
Women in 640 / 671 (#2 Cont.)
Author: CDER User