A pooled analysis of suicidality in double-blind, placebo-controlled studies of sertraline in adults.
OBJECTIVE
The analyses were conducted to identify possibly suicide-related adverse events in Pfizer-sponsored, phases 2 through 4, placebo-controlled, completed studies of sertraline in adult patients and evaluate the risk of suicidality with sertraline versus placebo.


METHODS
U.S. Food and Drug Administration (FDA)-defined search methodology was used to identify possibly suicide-related adverse events in short-term, all-duration/all-indication, and psychiatric studies of sertraline. Categorization of possibly suicide-related adverse events was based on the approach developed by the Columbia group for the FDA's analysis of pediatric suicide risk with antidepressants. The incidences of possibly suicide-related adverse events were calculated for individual classifications and for the predefined combined category of suicidality along with the sertraline versus placebo relative risks and corresponding 95% CI limits. Exact binomial CI limits were calculated for the individual treatment group incidences. Age group analyses were also performed using the age limits defined by the FDA.


RESULTS
Ninety-nine suicidality events were identified among 19,923 sertraline- and placebo-treated subjects participating in 126 studies conducted between the mid-1980s and the mid-2000s. Four cases of completed suicides among 10,917 sertraline-treated subjects yielded an incidence of 0.04% (95% CI = 0.01 to 0.09) and 3 cases among 9,006 placebo treated subjects yielded an incidence of 0.03% (95% CI = 0.01 to 0.10). There were no statistically significant differences between sertraline and placebo in any of the individual categories or combined suicidality risk category across all performed analyses.


CONCLUSIONS
Results of short-term, all-duration, and psychiatric studies analyses, as well as age-group analyses, performed in accordance with the FDA-specified search strategy, show no significant increase in suicidality risk in adult sertraline- versus placebo-treated patients.
Vanderburg
Douglas G
DG
Pfizer Inc, New York, NY 10017, USA. Douglas.Vanderburg@pfizer.com
Batzar
Evan
E
Fogel
Ilan
I
Kremer
Charlotte M E
CM
D000328:Adult; D000367:Age Factors; D000928:Antidepressive Agents / Q000009:adverse effects*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008016:Life Change Events; D008297:Male; D015995:Prevalence; D020280:Sertraline / Q000009:adverse effects*; D013406:Suicide, Attempted / Q000706:statistics & numerical data*; D055815:Young Adult
D000928:Antidepressive Agents; D020280:Sertraline