Title

Sertraline

Date

December 1991

Document Type

Article

Publisher

United States. Food and Drug Administration.

Description

Study 101 - This was a small inpatient study (N=93) involving 4 doses of sertraline and a placebo group. The difference between sertraline and placebo was nonsignificant for each of the doses. For the 100 mg group, sertraline performed numerically worse than placebo. This study was not published. Study 103 - In this study, sertraline was significantly better than placebo in one of the three doses tested. According to the FDA, this study was significant at the 50mg dose (p=0.018) but nonsignificant at 100 mg (p=0.084) and at 200 mg (p=0.210). The journal article, however, reported statistically significant results for all three doses. For a possible explanation of these discrepancies, please see Table B in the Supplemental Appendix to Dr. Turners article. Study 104 - This study involved a single sertraline dose group (50-200 mg) compared to placebo and the difference between the two groups was statistically significant according to the FDA as well as according to the journal article. Study 310 - A small inpatient study (N=146) involving 4 doses of sertraline compared to placebo. Also like Study 101 none of the dose groups separated from placebo. This study was not published. Study 315 - This study (N=148) involved a single dose group (50-200 mg) compared to placebo. The difference between sertraline and placebo was nonsignificant (p=0.046). This study was not published. Study 320 - This study, a 44-week maintenance study, was not covered in Dr. Turners paper since the paper focused on short-term studies. Studies 101 and 310 - This is a single page providing a general description of the two inpatient studes, 101 and 310.

Identifier

doi:10.6083/M4CN72MB

Note

New Drug Application Number: 1991-12-30

Brand name: 19-839

Generic Drug Name: Zoloft

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