Paroxetine treatment in children and adolescents with major depressive disorder

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

Graham J. Emslie, Karen Wagner, Stan Kutcher, Stan Krulewicz, Regan Fong, David J. Carpenter, Alan Lipschitz, Andrea Machin, Christel Wilkinson

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

Objective: To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder. Method: Subjects 7 to 17 years old with major depressive disorder received paroxetine (10-50 mg/day) or placebo for 8 weeks from 2000 to 2001. The primary efficacy measure was change from baseline in the Children's Depression Rating Scale-Revised total score at week 8 last observation carried forward). Safety was primarily assessed by spontaneous reporting of adverse events. Results: A total of 206 patients (intent to treat) were randomized to paroxetine (n = 104) or placebo (n = 102). Week 8 Children's Depression Rating Scale-Revised total score adjusted mean changes from baseline for patients receiving paroxetine and placebo were -22.58 (SE 1.47) and -23.38 points (SE 1.60), respectively (0.80, 95% confidence interval -3.09 to 4.69, p = 0.684). Increased cough (5.9% versus 2.9%), dyspepsia (5.9% versus 2.9%), vomiting (5.9% versus 2.0%), and dizziness (5.0% versus 1.0%) occurred in ≥5% of the paroxetine group and at least twice that of the placebo group. Six of 104 (5.8%) paroxetine patients reported serious adverse events compared to 1 placebo patient (1.0%). The incidence of adverse events of suicidal behavior and/or ideation while taking study medication (excluding taper) was 1.92% (2/104) for paroxetine versus 0.98% (1/102) for placebo. Conclusions: Paroxetine was not shown to be more efficacious than placebo for treating pediatric major depressive disorder.

Original languageEnglish (US)
Pages (from-to)709-719
Number of pages11
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume45
Issue number6
DOIs
StatePublished - Jun 2006

Fingerprint

Paroxetine
Major Depressive Disorder
Placebos
Therapeutics
Depression
Pediatrics
Dyspepsia
Dizziness
Cough
Vomiting
Observation
Confidence Intervals
Safety
Incidence

Keywords

  • Major depressive 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 major depressive disorder : A randomized, multicenter, double-blind, placebo-controlled trial. / Emslie, Graham J.; Wagner, Karen; Kutcher, Stan; Krulewicz, Stan; Fong, Regan; Carpenter, David J.; Lipschitz, Alan; Machin, Andrea; Wilkinson, Christel.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 45, No. 6, 06.2006, p. 709-719.

Research output: Contribution to journalArticle

Emslie, Graham J. ; Wagner, Karen ; Kutcher, Stan ; Krulewicz, Stan ; Fong, Regan ; Carpenter, David J. ; Lipschitz, Alan ; Machin, Andrea ; Wilkinson, Christel. / Paroxetine treatment in children and adolescents with major depressive disorder : A randomized, multicenter, double-blind, placebo-controlled trial. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2006 ; Vol. 45, No. 6. pp. 709-719.
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abstract = "Objective: To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder. Method: Subjects 7 to 17 years old with major depressive disorder received paroxetine (10-50 mg/day) or placebo for 8 weeks from 2000 to 2001. The primary efficacy measure was change from baseline in the Children's Depression Rating Scale-Revised total score at week 8 last observation carried forward). Safety was primarily assessed by spontaneous reporting of adverse events. Results: A total of 206 patients (intent to treat) were randomized to paroxetine (n = 104) or placebo (n = 102). Week 8 Children's Depression Rating Scale-Revised total score adjusted mean changes from baseline for patients receiving paroxetine and placebo were -22.58 (SE 1.47) and -23.38 points (SE 1.60), respectively (0.80, 95{\%} confidence interval -3.09 to 4.69, p = 0.684). Increased cough (5.9{\%} versus 2.9{\%}), dyspepsia (5.9{\%} versus 2.9{\%}), vomiting (5.9{\%} versus 2.0{\%}), and dizziness (5.0{\%} versus 1.0{\%}) occurred in ≥5{\%} of the paroxetine group and at least twice that of the placebo group. Six of 104 (5.8{\%}) paroxetine patients reported serious adverse events compared to 1 placebo patient (1.0{\%}). The incidence of adverse events of suicidal behavior and/or ideation while taking study medication (excluding taper) was 1.92{\%} (2/104) for paroxetine versus 0.98{\%} (1/102) for placebo. Conclusions: Paroxetine was not shown to be more efficacious than placebo for treating pediatric major depressive disorder.",
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T2 - A randomized, multicenter, double-blind, placebo-controlled trial

AU - Emslie, Graham J.

AU - Wagner, Karen

AU - Kutcher, Stan

AU - Krulewicz, Stan

AU - Fong, Regan

AU - Carpenter, David J.

AU - Lipschitz, Alan

AU - Machin, Andrea

AU - Wilkinson, Christel

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N2 - Objective: To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder. Method: Subjects 7 to 17 years old with major depressive disorder received paroxetine (10-50 mg/day) or placebo for 8 weeks from 2000 to 2001. The primary efficacy measure was change from baseline in the Children's Depression Rating Scale-Revised total score at week 8 last observation carried forward). Safety was primarily assessed by spontaneous reporting of adverse events. Results: A total of 206 patients (intent to treat) were randomized to paroxetine (n = 104) or placebo (n = 102). Week 8 Children's Depression Rating Scale-Revised total score adjusted mean changes from baseline for patients receiving paroxetine and placebo were -22.58 (SE 1.47) and -23.38 points (SE 1.60), respectively (0.80, 95% confidence interval -3.09 to 4.69, p = 0.684). Increased cough (5.9% versus 2.9%), dyspepsia (5.9% versus 2.9%), vomiting (5.9% versus 2.0%), and dizziness (5.0% versus 1.0%) occurred in ≥5% of the paroxetine group and at least twice that of the placebo group. Six of 104 (5.8%) paroxetine patients reported serious adverse events compared to 1 placebo patient (1.0%). The incidence of adverse events of suicidal behavior and/or ideation while taking study medication (excluding taper) was 1.92% (2/104) for paroxetine versus 0.98% (1/102) for placebo. Conclusions: Paroxetine was not shown to be more efficacious than placebo for treating pediatric major depressive disorder.

AB - Objective: To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder. Method: Subjects 7 to 17 years old with major depressive disorder received paroxetine (10-50 mg/day) or placebo for 8 weeks from 2000 to 2001. The primary efficacy measure was change from baseline in the Children's Depression Rating Scale-Revised total score at week 8 last observation carried forward). Safety was primarily assessed by spontaneous reporting of adverse events. Results: A total of 206 patients (intent to treat) were randomized to paroxetine (n = 104) or placebo (n = 102). Week 8 Children's Depression Rating Scale-Revised total score adjusted mean changes from baseline for patients receiving paroxetine and placebo were -22.58 (SE 1.47) and -23.38 points (SE 1.60), respectively (0.80, 95% confidence interval -3.09 to 4.69, p = 0.684). Increased cough (5.9% versus 2.9%), dyspepsia (5.9% versus 2.9%), vomiting (5.9% versus 2.0%), and dizziness (5.0% versus 1.0%) occurred in ≥5% of the paroxetine group and at least twice that of the placebo group. Six of 104 (5.8%) paroxetine patients reported serious adverse events compared to 1 placebo patient (1.0%). The incidence of adverse events of suicidal behavior and/or ideation while taking study medication (excluding taper) was 1.92% (2/104) for paroxetine versus 0.98% (1/102) for placebo. Conclusions: Paroxetine was not shown to be more efficacious than placebo for treating pediatric major depressive disorder.

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KW - Selective serotonin reuptake inhibitor

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