Maintenance phase efficacy of sertraline for chronic depression: A randomized controlled trial

Martin B. Keller, James H. Kocsis, Michael E. Thase, Alan J. Gelenberg, A. John Rush, Lorrin Koran, Alan Schatzberg, James Russell, Robert Hirschfeld, Daniel Klein, James P. McCullough, Jan A. Fawcett, Susan Kornstein, Lisa LaVange, Wilma Harrison

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)1665-1672
Number of pages8
JournalJournal of the American Medical Association
Volume280
Issue number19
StatePublished - Nov 18 1998

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Sertraline
Randomized Controlled Trials
Maintenance
Depression
Recurrence
Placebos
Therapeutics
Dysthymic Disorder
Cost of Illness
Random Allocation
Ambulatory Care Facilities
Proportional Hazards Models
Research
Psychiatry
Outpatients
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Keller, M. B., Kocsis, J. H., Thase, M. E., Gelenberg, A. J., Rush, A. J., Koran, L., ... Harrison, W. (1998). Maintenance phase efficacy of sertraline for chronic depression: A randomized controlled trial. Journal of the American Medical Association, 280(19), 1665-1672.

Maintenance phase efficacy of sertraline for chronic depression : A randomized controlled trial. / Keller, Martin B.; Kocsis, James H.; Thase, Michael E.; Gelenberg, Alan J.; Rush, A. John; Koran, Lorrin; Schatzberg, Alan; Russell, James; Hirschfeld, Robert; Klein, Daniel; McCullough, James P.; Fawcett, Jan A.; Kornstein, Susan; LaVange, Lisa; Harrison, Wilma.

In: Journal of the American Medical Association, Vol. 280, No. 19, 18.11.1998, p. 1665-1672.

Research output: Contribution to journalArticle

Keller, MB, Kocsis, JH, Thase, ME, Gelenberg, AJ, Rush, AJ, Koran, L, Schatzberg, A, Russell, J, Hirschfeld, R, Klein, D, McCullough, JP, Fawcett, JA, Kornstein, S, LaVange, L & Harrison, W 1998, 'Maintenance phase efficacy of sertraline for chronic depression: A randomized controlled trial', Journal of the American Medical Association, vol. 280, no. 19, pp. 1665-1672.
Keller MB, Kocsis JH, Thase ME, Gelenberg AJ, Rush AJ, Koran L et al. Maintenance phase efficacy of sertraline for chronic depression: A randomized controlled trial. Journal of the American Medical Association. 1998 Nov 18;280(19):1665-1672.
Keller, Martin B. ; Kocsis, James H. ; Thase, Michael E. ; Gelenberg, Alan J. ; Rush, A. John ; Koran, Lorrin ; Schatzberg, Alan ; Russell, James ; Hirschfeld, Robert ; Klein, Daniel ; McCullough, James P. ; Fawcett, Jan A. ; Kornstein, Susan ; LaVange, Lisa ; Harrison, Wilma. / Maintenance phase efficacy of sertraline for chronic depression : A randomized controlled trial. In: Journal of the American Medical Association. 1998 ; Vol. 280, No. 19. pp. 1665-1672.
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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.",
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AU - Rush, A. John

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AU - Schatzberg, Alan

AU - Russell, James

AU - Hirschfeld, Robert

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