TY - JOUR
T1 - Paroxetine treatment in children and adolescents with major depressive disorder
T2 - A randomized, multicenter, double-blind, placebo-controlled trial
AU - Emslie, Graham J.
AU - Wagner, Karen Dineen
AU - Kutcher, Stan
AU - Krulewicz, Stan
AU - Fong, Regan
AU - Carpenter, David J.
AU - Lipschitz, Alan
AU - Machin, Andrea
AU - Wilkinson, Christel
PY - 2006/6
Y1 - 2006/6
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.
KW - Major depressive disorder
KW - Paroxetine pediatric
KW - Selective serotonin reuptake inhibitor
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U2 - 10.1097/01.chi.0000214189.73240.63
DO - 10.1097/01.chi.0000214189.73240.63
M3 - Article
C2 - 16721321
AN - SCOPUS:33744819711
SN - 0890-8567
VL - 45
SP - 709
EP - 719
JO - Journal of the American Academy of Child Psychiatry
JF - Journal of the American Academy of Child Psychiatry
IS - 6
ER -