Paroxetine treatment in children and adolescents with major depressive disorder: a randomized, multicenter, double-blind, placebo-controlled trial.
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.
Emslie
Graham J
GJ
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.
Wagner
Karen Dineen
KD
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.
Kutcher
Stan
S
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.
Krulewicz
Stan
S
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.
Fong
Regan
R
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.
Carpenter
David J
DJ
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.
Lipschitz
Alan
A
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.
Machin
Andrea
A
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.
Wilkinson
Christel
C
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.
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
D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors