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Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder.
J Am Acad Child Adolesc Psychiatry. 1992 Nov; 31(6):1062-9.JA

Abstract

Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% (N = 7, p = .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease (N = 6, p = .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD (p = .01) but not by the CY-BOCS (p = .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.

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Authors+Show Affiliations

Riddle MA
Yale Child Study Center, Yale University School of Medicine, New Haven, CT 06510-8009.
Scahill L
No affiliation info available
King RA
No affiliation info available
Hardin MT
No affiliation info available
Anderson GM
No affiliation info available
Ort SI
No affiliation info available
Smith JC
No affiliation info available
Leckman JF
No affiliation info available
Cohen DJ
No affiliation info available

MeSH

AdolescentChildDouble-Blind MethodFemaleFluoxetineHumansMaleObsessive-Compulsive DisorderPersonality Assessment

Pub Type(s)

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

Language

eng

PubMed ID

1429406

Citation

Riddle, M A., et al. "Double-blind, Crossover Trial of Fluoxetine and Placebo in Children and Adolescents With Obsessive-compulsive Disorder." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 31, no. 6, 1992, pp. 1062-9.
Riddle MA, Scahill L, King RA, et al. Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 1992;31(6):1062-9.
Riddle, M. A., Scahill, L., King, R. A., Hardin, M. T., Anderson, G. M., Ort, S. I., Smith, J. C., Leckman, J. F., & Cohen, D. J. (1992). Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 31(6), 1062-9.
Riddle MA, et al. Double-blind, Crossover Trial of Fluoxetine and Placebo in Children and Adolescents With Obsessive-compulsive Disorder. J Am Acad Child Adolesc Psychiatry. 1992;31(6):1062-9. PubMed PMID: 1429406.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, crossover trial of fluoxetine and placebo in children and adolescents with obsessive-compulsive disorder. AU - Riddle,M A, AU - Scahill,L, AU - King,R A, AU - Hardin,M T, AU - Anderson,G M, AU - Ort,S I, AU - Smith,J C, AU - Leckman,J F, AU - Cohen,D J, PY - 1992/11/1/pubmed PY - 1992/11/1/medline PY - 1992/11/1/entrez SP - 1062 EP - 9 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 31 IS - 6 N2 - Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% (N = 7, p = .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease (N = 6, p = .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD (p = .01) but not by the CY-BOCS (p = .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD. SN - 0890-8567 UR - https://www.unboundmedicine.com/medline/citation/1429406/Double_blind_crossover_trial_of_fluoxetine_and_placebo_in_children_and_adolescents_with_obsessive_compulsive_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)64819-X DB - PRIME DP - Unbound Medicine ER -