TY - JOUR
T1 - Maintenance phase efficacy of sertraline for chronic depression
T2 - A randomized controlled trial
AU - Keller, Martin B.
AU - Kocsis, James H.
AU - Thase, Michael E.
AU - Gelenberg, Alan J.
AU - Rush, A. John
AU - Koran, Lorrin
AU - Schatzberg, Alan
AU - Russell, James
AU - Hirschfeld, Robert
AU - Klein, Daniel
AU - McCullough, James P.
AU - Fawcett, Jan A.
AU - Kornstein, Susan
AU - LaVange, Lisa
AU - Harrison, Wilma
PY - 1998/11/18
Y1 - 1998/11/18
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/0032544990
UR - https://www.scopus.com/pages/publications/0032544990#tab=citedBy
U2 - 10.1001/jama.280.19.1665
DO - 10.1001/jama.280.19.1665
M3 - Article
C2 - 9831997
AN - SCOPUS:0032544990
SN - 0098-7484
VL - 280
SP - 1665
EP - 1672
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 19
ER -