In the primary multicenter, double-blind trial, outpatients with recurrent MDD (N¼1096) were randomized to receive 10-week acute-phase treatment with venlafaxine XR (75 mg/d to 300 mg/d) or fluoxetine (20 mg/d to 60 mg/d), followed by a 6-month continuation phase. Subsequently, at the start of 2 consecutive, double-blind, 12-month maintenance phases, venlafaxine XR responders were randomized to receive venlafaxine XR or placebo. Data from the 24 months of maintenance treatment were analyzed for the combined end point of maintenance of response (ie, no recurrence of depression and no dose increase above 225 mg/d), and each component individually. Time to each outcome was evaluated with Kaplan-Meier methods using log-rank tests for venlafaxine XR-placebo comparisons. Results: The analysis population included 114 patients who had received venlafaxine XR doses less than or equal to 225 mg/d prior to maintenance phase baseline (venlafaxine XR: n¼55; placebo: n¼59). Probability estimates for maintaining response were 70% for venlafaxine XR and 38% for placebo (P¼0.007), for no dose increase were 76% and 58%, respectively (P¼0.019), and for no recurrence were 87% vs 65%, respectively (P¼.099). Conclusions: These data confirm venlafaxine XR is effective maintaining response at doses 225 mg/d for up to 2.5 years in patients with MDD.
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