Milnacipran efficacy in the prevention of recurrent depression: a 12-monthplacebo-controlled study

To compare the efficacy and assess the tolerability of milnacipran 50 mg p. o. b.i.d. to placebo in the prevention of recurrence in depressed patients who had responded an acute treatment and had remained in remission during a 4-month continuation phase. Remission criteria were: a Hamilton Depression Rating Scale (HDRS) (21-item) less than or equal to 8, improvement or disa ppearance of the initial symptoms, and an assessment of 'very much improved ' or 'much improved' on the Clinical Global Impression (CGI) Subscale: Glob al Improvement. Recurrence was defined by a major depressive episode accord ing to DSM-III-R criteria and a minimum score of 18 on the HDRS, with the n eed to treat the recurrence. The primary analysis was the rate of recurrenc e as a function of time in the intent-to-treat population. Groups were comp ared using the Cox model. Absolute recurrence rates were 16.3% (17/104) in milnacipran-treated patients and 23.6% (26/110) in placebo-treated patients , with a significant difference in the reduction of recurrence as a functio n of time (Kaplan Meier Survival Analysis analysis, P < 0.05). There was no difference in tolerability between groups. This study demonstrates that mi lnacipran is effective with good tolerability in preventing recurrence in m ajor depressive disorder over 1 year in patients with recurrent depression who responded to acute treatment with milnacipran and continued their respo nse for 18 weeks. (C) 2000 Lippincott Williams gi Wilkins.