title: Paroxetine treatment in children and adolescents with major depressive disorder: a randomized, multicenter, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder.
  
  
  METHODS
  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 >or=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.
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK. Electronic address: graham.emslie@utsouthwestern.edu.
authors.forename: Graham J
authors.initials: GJ
authors.lastname: Emslie
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Karen Dineen
authors.initials: KD
authors.lastname: Wagner
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Stan
authors.initials: S
authors.lastname: Kutcher
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Stan
authors.initials: S
authors.lastname: Krulewicz
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Regan
authors.initials: R
authors.lastname: Fong
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: David J
authors.initials: DJ
authors.lastname: Carpenter
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Lipschitz
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Andrea
authors.initials: A
authors.lastname: Machin
authors.affiliation: Dr. Emslie is with the University of Texas Southwestern Medical Center at Dallas; Dr. Wagner is with the University of Texas Medical Branch at Galveston; Dr. Kutcher is with Dalhousie University in Halifax, Nova Scotia, Canada; Mr. Krulewicz and Drs. Fong, Carpenter, and Lipschitz are with GlaxoSmithKline, King of Prussia, PA; Ms. Machin and Ms. Wilkinson are with GlaxoSmithKline, Harlow, Essex, UK.
authors.forename: Christel
authors.initials: C
authors.lastname: Wilkinson
mesh_terms: D000293:Adolescent; D002648:Child; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D017374:Paroxetine / Q000627:therapeutic use*; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors