Paroxetine treatment in children and adolescents with obsessive-compulsive disorder

A randomized, multicenter, double-blind, placebo-controlled trial

Daniel A. Geller, Karen Wagner, Graham Emslie, Tanya Murphy, David J. Carpenter, Erica Wetherhold, Phil Perera, Andrea Machin, Christel Gardiner

Research output: Contribution to journalArticle

138 Citations (Scopus)

Abstract

Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder. Method: Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring. Results: A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE = 0.82) and -5.34 points (SE = 0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95% confidence interval = -5.60 to -1.29, p = .002). Adverse events were generally mild to moderate in intensity. A total of 10.2% (10/98) of patients in the paroxetine group and 2.9% (3 of 105) in the placebo group discontinued treatment because of adverse events. Conclusions: Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.

Original languageEnglish (US)
Pages (from-to)1387-1396
Number of pages10
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume43
Issue number11
DOIs
StatePublished - Nov 2004

Fingerprint

Paroxetine
Obsessive-Compulsive Disorder
Placebos
Therapeutics
Observation
Safety
Diagnostic and Statistical Manual of Mental Disorders
Confidence Intervals
Pediatrics
Population

Keywords

  • Obsessive-compulsive disorder
  • Paroxetine
  • Pediatric
  • Selective serotonin reuptake inhibitor

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Paroxetine treatment in children and adolescents with obsessive-compulsive disorder : A randomized, multicenter, double-blind, placebo-controlled trial. / Geller, Daniel A.; Wagner, Karen; Emslie, Graham; Murphy, Tanya; Carpenter, David J.; Wetherhold, Erica; Perera, Phil; Machin, Andrea; Gardiner, Christel.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 43, No. 11, 11.2004, p. 1387-1396.

Research output: Contribution to journalArticle

Geller, Daniel A. ; Wagner, Karen ; Emslie, Graham ; Murphy, Tanya ; Carpenter, David J. ; Wetherhold, Erica ; Perera, Phil ; Machin, Andrea ; Gardiner, Christel. / Paroxetine treatment in children and adolescents with obsessive-compulsive disorder : A randomized, multicenter, double-blind, placebo-controlled trial. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2004 ; Vol. 43, No. 11. pp. 1387-1396.
@article{bfc51cc9f0e149a1976ba1522f23a000,
title = "Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: A randomized, multicenter, double-blind, placebo-controlled trial",
abstract = "Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder. Method: Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring. Results: A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE = 0.82) and -5.34 points (SE = 0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95{\%} confidence interval = -5.60 to -1.29, p = .002). Adverse events were generally mild to moderate in intensity. A total of 10.2{\%} (10/98) of patients in the paroxetine group and 2.9{\%} (3 of 105) in the placebo group discontinued treatment because of adverse events. Conclusions: Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.",
keywords = "Obsessive-compulsive disorder, Paroxetine, Pediatric, Selective serotonin reuptake inhibitor",
author = "Geller, {Daniel A.} and Karen Wagner and Graham Emslie and Tanya Murphy and Carpenter, {David J.} and Erica Wetherhold and Phil Perera and Andrea Machin and Christel Gardiner",
year = "2004",
month = "11",
doi = "10.1097/01.chi.0000138356.29099.f1",
language = "English (US)",
volume = "43",
pages = "1387--1396",
journal = "Journal of the American Academy of Child and Adolescent Psychiatry",
issn = "0890-8567",
publisher = "Elsevier Limited",
number = "11",

}

TY - JOUR

T1 - Paroxetine treatment in children and adolescents with obsessive-compulsive disorder

T2 - A randomized, multicenter, double-blind, placebo-controlled trial

AU - Geller, Daniel A.

AU - Wagner, Karen

AU - Emslie, Graham

AU - Murphy, Tanya

AU - Carpenter, David J.

AU - Wetherhold, Erica

AU - Perera, Phil

AU - Machin, Andrea

AU - Gardiner, Christel

PY - 2004/11

Y1 - 2004/11

N2 - Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder. Method: Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring. Results: A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE = 0.82) and -5.34 points (SE = 0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95% confidence interval = -5.60 to -1.29, p = .002). Adverse events were generally mild to moderate in intensity. A total of 10.2% (10/98) of patients in the paroxetine group and 2.9% (3 of 105) in the placebo group discontinued treatment because of adverse events. Conclusions: Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.

AB - Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder. Method: Children (7-11 years of age) and adolescents (12-17 years of age) meeting DSM-IV criteria for obsessive-compulsive disorder were randomized to paroxetine (10-50 mg/day) or placebo for 10 weeks. The primary efficacy measure was change from baseline in the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score at week 10 last observation carried forward end point. Safety was assessed primarily through adverse event monitoring. Results: A total of 207 patients were randomized to treatment. Of these, 203 were included in the intention-to-treat population. Adjusted mean changes from baseline at week 10 observation carried forward end point in CY-BOCS total score for patients receiving paroxetine and placebo were -8.78 (SE = 0.82) and -5.34 points (SE = 0.77), respectively. The adjusted mean difference, -3.45 in favor of paroxetine, was statistically significant (95% confidence interval = -5.60 to -1.29, p = .002). Adverse events were generally mild to moderate in intensity. A total of 10.2% (10/98) of patients in the paroxetine group and 2.9% (3 of 105) in the placebo group discontinued treatment because of adverse events. Conclusions: Paroxetine is an effective and generally well-tolerated treatment for obsessive-compulsive disorder in children and adolescents.

KW - Obsessive-compulsive disorder

KW - Paroxetine

KW - Pediatric

KW - Selective serotonin reuptake inhibitor

UR - http://www.scopus.com/inward/record.url?scp=6944234948&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=6944234948&partnerID=8YFLogxK

U2 - 10.1097/01.chi.0000138356.29099.f1

DO - 10.1097/01.chi.0000138356.29099.f1

M3 - Article

VL - 43

SP - 1387

EP - 1396

JO - Journal of the American Academy of Child and Adolescent Psychiatry

JF - Journal of the American Academy of Child and Adolescent Psychiatry

SN - 0890-8567

IS - 11

ER -