Suicidal thinking and behavior during treatment with sertraline in late-life depression

Objective: To determine effects of sertraline on suicidal thinking and behavior in patients with late-life major depression. Methods: This was a secondary analysis of an eight-week, placebo-controlled, double-blind randomized trial of a multicenter trial at 66 clinical sites. Outpatients >= 60 years of age with major depression and a Hamilton Depression Rating ( HAMD) score >= 18 were included. Intervention was sertraline 50 - 100 mg/day or placebo for eight weeks. Measurements were 17-item HAMD administered at baseline and two-week intervals. HAMD Item 3 used to assess suicidal ideation ( SI) and behavior. Reports of serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and spontaneously reported adverse events reviewed. Results: A total of 747 patients received at least one dose of medication, and 728 had at least one posttreatment assessment. Mean age ( +/- SD) was 69.8 +/- 6.7 years ( range: 59 - 97 years) and 56% were female. There were no completed suicides or suicide attempts during the double-blind trial. One SAE, hospitalization, was associated with SI in a patient on sertraline. No other AEs were associated with SI or behavior. HAMD Item 3 ratings progressively declined during the trial with significantly lower values for sertraline than placebo ( Z = 2.41, p < 0.02). In 248 patients with HAMD Item 3 of zero at baseline, the percentage of patients whose Item 3 ratings increased during treatment did not differ in the two groups (22.4% versus 25.8% for sertraline and placebo, respectively.) Conclusion: Sertraline was associated with significantly lower HAMD Item 3 scores than placebo during treatment. There was no evidence of greater emergent suicidal thinking or behavior with sertraline than placebo.