Escitalopram in the acute treatment of depressed patients aged 60 years or older.

OBJECTIVE: The present study examined the efficacy and tolerability of acute escitalopram treatment in depressed patients aged 60 years or older. METHODS: Patients aged > or =60 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition major depressive disorder were randomized to 12 weeks of double-blind, flexible-dose treatment with escitalopram (10-20 mg/day; N = 130) or placebo (N = 134). The prospectively defined primary efficacy end point was change from baseline to week 12 in Montgomery-Asberg Depression Rating Scale (MADRS) total score using the last observation carried forward approach. RESULTS: A total of 109 (81%) patients in the placebo group and 96 (74%) patients in the escitalopram group completed treatment. Mean age in both groups was approximately 68 years. Mean baseline MADRS scores were 28.4 and 29.4 for the placebo and escitalopram treatment groups, respectively. Escitalopram did not achieve statistical significance compared with placebo in change from baseline on the MADRS (least square mean difference: -1.34; last observation carried forward). Discontinuation rates resulting from adverse events were 6% for placebo and 11% for escitalopram. Treatment-emergent adverse events reported by >10% of patients in the escitalopram group were headache, nausea, diarrhea, and dry mouth. CONCLUSIONS: Escitalopram treatment was not significantly different from placebo treatment on the primary efficacy measure, change from baseline to week 12 in MADRS. In patients aged 60 years or older with major depression, acute escitalopram treatment appeared to be well tolerated.