Sertraline for PTSD: NDA 19-839 David Smith, Ph.D. Statistical Reviewer Office of Biostatistics U.S. Food and Drug Admin. 8 October 1999

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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

Author: CDER User