Maintenance Phase Efficacy of Sertraline for Chronic Depression
A Randomized Controlled Trial
- Martin B. Keller, MD;
- James H. Kocsis, MD;
- Michael E. Thase, MD;
- Alan J. Gelenberg, MD;
- A. John Rush, MD;
- Lorrin Koran, MD;
- Alan Schatzberg, MD;
- James Russell, MD;
- Robert Hirschfeld, MD;
- Daniel Klein, PhD;
- James P. McCullough, PhD;
- Jan A. Fawcett, MD;
- Susan Kornstein, MD;
- Lisa LaVange, PhD;
- Wilma Harrison, MD;
- for the Sertraline Chronic Depression Study Group
- From the Departments of Psychiatry, Butler Hospital, Brown University, Providence, RI (Dr Keller); Cornell University School of Medicine, New York, NY (Dr Kocsis); University of Pittsburgh and Western Psychiatric Institute, Pittsburgh, Pa (Dr Thase); University of Arizona, Tucson (Dr Gelenberg); University of Texas Southwestern Medical Center, Dallas (Dr Rush); Stanford University School of Medicine, Stanford, Calif (Drs Koran and Schatzberg); University of Texas Medical Branch at Galveston (Drs Russell and Hirschfeld); State University of New York at Stony Brook (Dr Klein); Medical College of Virginia, Virginia Commonwealth University, Richmond (Drs McCullough and Kornstein); Rush Institute for Mental Well-Being, Chicago, Ill (Dr Fawcett); Quintiles, Research Triangle Park, NC (Dr LaVange); Pfizer Inc, and College of Physicians and Surgeons, Columbia University, New York, NY (Dr Harrison).
Abstract
Context.— The chronic form of major depression is associated with a high rate of prevalence and disability, but no controlled research has examined the impact of long-term treatment on the course and burden of illness.
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 depression").
Design.— A 76-week randomized, double-blind, parallel-group study, conducted from September 1993 to November 1996.
Setting.— Outpatient psychiatric clinics at 10 academic medical centers and 2 clinical research centers.
Intervention.— Maintenance treatment with either sertraline hydrochloride (n=77) in flexible doses up to 200 mg or placebo (n=84).
Patients.— A total of 161 outpatients with chronic major or double depression who responded to sertraline in a 12-week, double-blind, acute-phase treatment trial and continued to have a satisfactory therapeutic response during a subsequent 4-month continuation phase.
Main Outcome Measure.— Time to recurrence of major depression.
Results.— Sertraline 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-recurrence distributions). Clinically significant depressive symptoms reemerged 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 proportional hazards model, patients receiving placebo were 4.07 times more likely (95% CI, 1.51-10.95; P=.005) to experience a depression recurrence, after adjustment for study site, type of depression, and randomization strata.
Conclusions.— Maintenance therapy with sertraline is well tolerated and has significant efficacy in preventing recurrence or reemergence of depression in chronically depressed patients.
