Ar. Entsuah et al., EFFICACY OF VENLAFAXINE AND PLACEBO DURING LONG-TERM TREATMENT OF DEPRESSION - A POOLED ANALYSIS OF RELAPSE RATES, International clinical psychopharmacology, 11(2), 1996, pp. 137-145
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.