MAINTENANCE PHASE EFFICACY OF SERTRALINE FOR CHRONIC DEPRESSION - A RANDOMIZED CONTROLLED TRIAL

Context.-The chronic form of major depression is associated with a hig h rate of prevalence and disability, but no controlled research has ex amined the impact of long-term treatment on the course and burden of i llness. Objective.-To determine if maintenance therapy with sertraline hydrochloride can effectively prevent recurrence of depression in the high-risk group of patients experiencing chronic major depression or major depression with antecedent dysthymic disorder (''double depressi on''). Design.-A 76-week randomized, double-blind, parallel-group stud y, conducted from September 1993 to November 1996, Setting.-Outpatient psychiatric clinics at 10 academic medical centers and 2 clinical res earch centers. Intervention.-Maintenance treatment with either sertral ine hydrochloride (n = 77) in flexible doses up to 200 mg or placebo ( n = 84), Patients.-A total of 161 outpatients with chronic major or do uble depression who responded to sertraline in a 12-week, double-blind , acute-phase treatment trial and continued to have a satisfactory the rapeutic response during a subsequent 4-month continuation phase. Main Outcome Measure.-Time to recurrence of major depression. Results.-Ser traline afforded significantly greater prophylaxis against recurrence than did placebo (5 [6%] of 77 in the sertraline group vs 19 [23%] of 84 in the placebo group; P = .002 for the log-rank test of time-to-rec urrence distributions). Clinically significant depressive symptoms ree merged in 20 (26%) of 77 patients treated with sertraline vs 42 (50%) of 84 patients who received placebo (P=.001), With use of a Cox propor tional hazards model, patients receiving placebo were 4.07 times more likely (95% CI, 1.51-10.95; P=.005) to experience a depression recurre nce, after adjustment for study site, type of depression, and randomiz ation strata. Conclusions.-Maintenance therapy with sertraline is well tolerated and has significant efficacy in preventing recurrence or re emergence of depression in chronically depressed patients.