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CNS Spectr. 2007 Feb;12(2):147-54.

Do children and adolescents have differential response rates in placebo-controlled trials of fluoxetine?

Author information

  • 1Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-8589, USA. taryn.mayes@utsouthwestern.edu

Abstract

OBJECTIVE:

Recent acute efficacy trials of antidepressants in youth have suggested that high placebo-response rates in children (< 12 years of age) indicate that children may be more responsive to non-specific treatment interventions. Yet, these studies generally have not presented age-specific outcome data. The objective of this study was to compare the efficacy outcomes for children (< 12 years of age) and adolescents (> or = 12 years of age) using the combined data from two previously published double-blind, placebo-controlled trials of fluoxetine.

METHODS:

Children (< 12 years of age) and adolescents (> or = 12 years of age) with major depressive disorder were randomized to fluoxetine or placebo for 8-9 weeks of treatment. Outcome was assessed using the Children's Depression Rating Scale-Revised (CDRS-R) and Clinical Global Impressions scale.

RESULTS:

Random regression of the CDRS-R showed a treatment group by age group interaction (F(1,338)=4.10, P=.044), indicating that the treatment effect was significantly more pronounced in children than adolescents. Within children, response at exit to fluoxetine was significantly better than placebo (56.9% vs 33.3%; P=.009). Adolescent response rates at exit were not significantly different between the groups (51.1% vs 38.6%; P=.128). Remission rates were low for both groups.

CONCLUSION:

In the combined fluoxetine trials, drug-placebo difference was greater in children compared with adolescents. Contrary to expectations, the placebo-response rate was lower in the children than the adolescents.

PMID:
17277715
[PubMed - indexed for MEDLINE]
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