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Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial.
J Am Acad Child Adolesc Psychiatry. 2004 Nov; 43(11):1387-96.JA

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.

Authors+Show Affiliations

Harvard Medical School, Boston, MA 02114, USA. dageller@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15502598

Citation

Geller, Daniel A., et al. "Paroxetine Treatment in Children and Adolescents With Obsessive-compulsive Disorder: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 43, no. 11, 2004, pp. 1387-96.
Geller DA, Wagner KD, Emslie G, et al. Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2004;43(11):1387-96.
Geller, D. A., Wagner, K. D., Emslie, G., Murphy, T., Carpenter, D. J., Wetherhold, E., Perera, P., Machin, A., & Gardiner, C. (2004). Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry, 43(11), 1387-96.
Geller DA, et al. Paroxetine Treatment in Children and Adolescents With Obsessive-compulsive Disorder: a Randomized, Multicenter, Double-blind, Placebo-controlled Trial. J Am Acad Child Adolesc Psychiatry. 2004;43(11):1387-96. PubMed PMID: 15502598.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Paroxetine treatment in children and adolescents with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled trial. AU - Geller,Daniel A, AU - Wagner,Karen Dineen, AU - Emslie,Graham, AU - Murphy,Tanya, AU - Carpenter,David J, AU - Wetherhold,Erica, AU - Perera,Phil, AU - Machin,Andrea, AU - Gardiner,Christel, PY - 2004/10/27/pubmed PY - 2005/1/26/medline PY - 2004/10/27/entrez SP - 1387 EP - 96 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 43 IS - 11 N2 - 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. SN - 0890-8567 UR - https://www.unboundmedicine.com/medline/citation/15502598/Paroxetine_treatment_in_children_and_adolescents_with_obsessive_compulsive_disorder:_a_randomized_multicenter_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)61608-7 DB - PRIME DP - Unbound Medicine ER -