Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine

Eric Hollander, Andrea Allen, Martin Steiner, David E. Wheadon, Rosemary Oakes, Daniel B. Burnham

Research output: Contribution to journalArticle

108 Citations (Scopus)

Abstract

Background: Limited information is available regarding optimal dosing or long-term pharmacotherapy with serotonin reuptake inhibitors in obsessive-compulsive disorder. This study evaluated the acute safety and efficacy and long-term efficacy, safety, and impact on relapse prevention of paroxetine in obsessive-compulsive disorder. Method: We enrolled 348 outpatients with DSM-III-R obsessive-compulsive disorder in phase 1, a 12-week randomized, double-blind, parallel study of fixed doses of paroxetine (20 mg/day, 40 mg/day, or 60 mg/day) and placebo. In phase 2, 263 phase 1 completers were enrolled in 6 months of flexibly dosed open-label paroxetine treatment. In phase 3, 105 responders to open-label paroxetine were randomized to 6-month double-blind, fixed-dose, parallel paroxetine/placebo treatment to evaluate long-term efficacy, safety, and impact on relapse prevention. The study was conducted from July 1991 to February 1994. Results: Patients in phase 1 acute treatment receiving 40 mg/day or 60 mg/day of paroxetine improved significantly (p < .05) more than those receiving placebo; the mean reduction in Yale-Brown Obsessive-Compulsive Scale score was 25% on 40 mg/day of paroxetine and 29% on 60 mg/day compared with 13% on placebo. During phase 3, long-term treatment, a greater proportion of placebo- (59%) than paroxetine-treated (38%) patients relapsed. Paroxetine was well tolerated at all doses, with no significant increase in frequency of adverse events during long-term compared with short-term therapy. Greater adverse events in the placebo than in the paroxetine group in phase 3 probably represent a discontinuation effect. Conclusion: Paroxetine doses of 40 mg/day and 60 mg/day (but not 20 mg/day) are effective in treating acute obsessive-compulsive disorder. Long-term treatment with paroxetine is effective and safe, decreases the rate of relapse, and lengthens the time to relapse.

Original languageEnglish (US)
Pages (from-to)1113-1121
Number of pages9
JournalJournal of Clinical Psychiatry
Volume64
Issue number9
StatePublished - Sep 1 2003
Externally publishedYes

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Paroxetine
Obsessive-Compulsive Disorder
Secondary Prevention
Placebos
Therapeutics
Safety
Recurrence
Serotonin Uptake Inhibitors
Double-Blind Method
Diagnostic and Statistical Manual of Mental Disorders
Outpatients

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Hollander, E., Allen, A., Steiner, M., Wheadon, D. E., Oakes, R., & Burnham, D. B. (2003). Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine. Journal of Clinical Psychiatry, 64(9), 1113-1121.

Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine. / Hollander, Eric; Allen, Andrea; Steiner, Martin; Wheadon, David E.; Oakes, Rosemary; Burnham, Daniel B.

In: Journal of Clinical Psychiatry, Vol. 64, No. 9, 01.09.2003, p. 1113-1121.

Research output: Contribution to journalArticle

Hollander, E, Allen, A, Steiner, M, Wheadon, DE, Oakes, R & Burnham, DB 2003, 'Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine', Journal of Clinical Psychiatry, vol. 64, no. 9, pp. 1113-1121.
Hollander, Eric ; Allen, Andrea ; Steiner, Martin ; Wheadon, David E. ; Oakes, Rosemary ; Burnham, Daniel B. / Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine. In: Journal of Clinical Psychiatry. 2003 ; Vol. 64, No. 9. pp. 1113-1121.
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abstract = "Background: Limited information is available regarding optimal dosing or long-term pharmacotherapy with serotonin reuptake inhibitors in obsessive-compulsive disorder. This study evaluated the acute safety and efficacy and long-term efficacy, safety, and impact on relapse prevention of paroxetine in obsessive-compulsive disorder. Method: We enrolled 348 outpatients with DSM-III-R obsessive-compulsive disorder in phase 1, a 12-week randomized, double-blind, parallel study of fixed doses of paroxetine (20 mg/day, 40 mg/day, or 60 mg/day) and placebo. In phase 2, 263 phase 1 completers were enrolled in 6 months of flexibly dosed open-label paroxetine treatment. In phase 3, 105 responders to open-label paroxetine were randomized to 6-month double-blind, fixed-dose, parallel paroxetine/placebo treatment to evaluate long-term efficacy, safety, and impact on relapse prevention. The study was conducted from July 1991 to February 1994. Results: Patients in phase 1 acute treatment receiving 40 mg/day or 60 mg/day of paroxetine improved significantly (p < .05) more than those receiving placebo; the mean reduction in Yale-Brown Obsessive-Compulsive Scale score was 25{\%} on 40 mg/day of paroxetine and 29{\%} on 60 mg/day compared with 13{\%} on placebo. During phase 3, long-term treatment, a greater proportion of placebo- (59{\%}) than paroxetine-treated (38{\%}) patients relapsed. Paroxetine was well tolerated at all doses, with no significant increase in frequency of adverse events during long-term compared with short-term therapy. Greater adverse events in the placebo than in the paroxetine group in phase 3 probably represent a discontinuation effect. Conclusion: Paroxetine doses of 40 mg/day and 60 mg/day (but not 20 mg/day) are effective in treating acute obsessive-compulsive disorder. Long-term treatment with paroxetine is effective and safe, decreases the rate of relapse, and lengthens the time to relapse.",
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AB - Background: Limited information is available regarding optimal dosing or long-term pharmacotherapy with serotonin reuptake inhibitors in obsessive-compulsive disorder. This study evaluated the acute safety and efficacy and long-term efficacy, safety, and impact on relapse prevention of paroxetine in obsessive-compulsive disorder. Method: We enrolled 348 outpatients with DSM-III-R obsessive-compulsive disorder in phase 1, a 12-week randomized, double-blind, parallel study of fixed doses of paroxetine (20 mg/day, 40 mg/day, or 60 mg/day) and placebo. In phase 2, 263 phase 1 completers were enrolled in 6 months of flexibly dosed open-label paroxetine treatment. In phase 3, 105 responders to open-label paroxetine were randomized to 6-month double-blind, fixed-dose, parallel paroxetine/placebo treatment to evaluate long-term efficacy, safety, and impact on relapse prevention. The study was conducted from July 1991 to February 1994. Results: Patients in phase 1 acute treatment receiving 40 mg/day or 60 mg/day of paroxetine improved significantly (p < .05) more than those receiving placebo; the mean reduction in Yale-Brown Obsessive-Compulsive Scale score was 25% on 40 mg/day of paroxetine and 29% on 60 mg/day compared with 13% on placebo. During phase 3, long-term treatment, a greater proportion of placebo- (59%) than paroxetine-treated (38%) patients relapsed. Paroxetine was well tolerated at all doses, with no significant increase in frequency of adverse events during long-term compared with short-term therapy. Greater adverse events in the placebo than in the paroxetine group in phase 3 probably represent a discontinuation effect. Conclusion: Paroxetine doses of 40 mg/day and 60 mg/day (but not 20 mg/day) are effective in treating acute obsessive-compulsive disorder. Long-term treatment with paroxetine is effective and safe, decreases the rate of relapse, and lengthens the time to relapse.

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