Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial.
OBJECTIVE
To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder.


METHODS
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.
Geller
Daniel A
DA
Harvard Medical School, Boston, MA 02114, USA. dageller@partners.org
Wagner
Karen Dineen
KD
Emslie
Graham
G
Murphy
Tanya
T
Carpenter
David J
DJ
Wetherhold
Erica
E
Perera
Phil
P
Machin
Andrea
A
Gardiner
Christel
C
D000284:Administration, Oral; D000293:Adolescent; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D017374:Paroxetine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors