EFFICACY OF VENLAFAXINE AND PLACEBO DURING LONG-TERM TREATMENT OF DEPRESSION - A POOLED ANALYSIS OF RELAPSE RATES

The objective of this analysis was to determine the efficacy of venlaf axine in comparison with that of placebo during long-term treatment. A pooled analysis of relapse rates in outpatients with major depression continuing long-term treatment (up to 12 months) after responding to short-term treatment (6 weeks) was performed combining the data from f our randomized, double-blind, placebo-controlled clinical trials. Rela pses were defined as two consecutive Clinical Global Impression (CGI) severity scores greater than 3 (mildly ill), as a CGI severity score g reater than 3 at withdrawal regardless of the reason for withdrawal, o r as withdrawal due to lack of efficacy. Data from 304 patients (185 v enlafaxine, 119 placebo) well balanced for baseline characteristics we re included in the pooled analysis. Percentages of patients completing the long-term phase were 38% venlafaxine and 26% placebo (p = 0.034). Cumulative relapse rates by 6 months of long-term treatment were 11% venlafaxine and 23% placebo (p = 0.019). Cumulative relapse curves for the venlafaxine and placebo groups over the 1-year long-term treatmen t differed significantly (p = 0.022). The results from this analysis i ndicate that long-term treatment with venlafaxine in patients with maj or depressive disorder is effective in maintaining the initial respons e compared with placebo and suggest that venlafaxine will be effective in the prevention of relapse.