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Paroxetine Treatment in Children and Adolescents with Obsessive-Compulsive Disorder: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

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Bibliographic Details
Title: Paroxetine Treatment in Children and Adolescents with Obsessive-Compulsive Disorder: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial
Language: English
Authors: Geller, Daniel A., Wagner, Karen Dineen, Emslie, Graham
Source: Journal of the American Academy of Child and Adolescent Psychiatry. Nov 2004 43(11):1387-1396.
Availability: Lippincott Williams & Wilkins, P.O. Box 1620, Hagerstown, MD 21741. Tel: 800-638-3030 (Toll Free); Fax: 301-223-2400.
Peer Reviewed: Y
Page Count: 10
Publication Date: 2004
Document Type: Journal Articles
Education Level: Elementary Secondary Education
Descriptors: Behavior Change, Psychological Patterns, Adolescents, Pediatrics, Emotional Disturbances, Children, Mental Disorders, Drug Therapy
ISSN: 0890-8567
Abstract: Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder.Method: 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. J. Am. Acad. Child Adolesc. Psychiatry. 2004:43(11):1387-1396. Key Words: obsessive-compulsive disorder, selective serotonin reuptake inhibitor, paroxetine, pediatric.
Abstractor: Author
Entry Date: 2005
Accession Number: EJ696666
Database: ERIC
Description
Abstract:Objective: To assess the efficacy and safety of paroxetine for the treatment of pediatric obsessive-compulsive disorder.Method: 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. J. Am. Acad. Child Adolesc. Psychiatry. 2004:43(11):1387-1396. Key Words: obsessive-compulsive disorder, selective serotonin reuptake inhibitor, paroxetine, pediatric.
ISSN:0890-8567