A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression

Background: Despite the high prevalence of depression in elderly patients, few well-designed, placebo-controlled studies of antidepressants have been conducted in this population. This masked, placebo-controlled trial assessed the efficacy and safety of venlafaxine and fluoxetine in depressed patients older than 65 years. Method: Three hundred patients were randomly assigned to treatment with venlafaxine immediate release ([IR]; N = 104), fluoxetine (N = 100), or placebo (N = 96) in an eight-week trial. Venlafaxine doses were titrated from 37.5 to 225 mg per day and fluoxetine doses were titrated from 20 to 60 mg per day, as necessary, over 29 days. Efficacy variables included the 21-item Hamilton Depression Rating Scale (HAM-D21) total score, HAM-D-21 depressed mood item score, scores on the Montgomery angstrom sberg Depression Rating Scale (MADRS), Clinical Global Impression-Severity of Illness (CGI-S) and Improvement (CGI-I) scales, and rates of response (based on change from baseline HAM-D or MADRS score or CGI-I score) and remission (HAM-D-17 <= 7). For the purposes of this report, efficacy analyses are focused on the HAM-D21 total score. Safety assessments included monitoring of adverse events (AEs), physical examinations, vital signs assessments, laboratory determinations, and electrocardiograms. Results: In all three of the treatment groups, there was a significant reduction at week 8 compared with the baseline HAM-D-21 total score. However, there were no significant differences among the three treatment groups on the change in HAM-D-21, MADRS, or CGI scores from baseline to week 8. There was no statistically significant difference in the proportion of remitters at the last on-therapy visit. The incidence of individual AEs was higher in the venlafaxine group (27%) compared with patients taking fluoxetine (19%) or placebo (9%). Conclusion: In this study, there was no significant difference in efficacy among placebo, venlafaxine, and fluoxetine for the treatment of depression.