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Do Children and Adolescents Have Differential Response Rates in Placebo-Controlled Trials of Fluoxetine?

  • Taryn L. Mayes, Rongrong Tao, Jeanne W. Rintelmann, Thomas Carmody, Carroll W. Hughes, Beth D. Kennard, Sunita M. Stewart and Graham J. Emslie...

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 (≥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 (≥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 (F1,338=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.

Copyright

Corresponding author

Please direct all correspondence to: Taryn L. Mayes, MS, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd, Dallas, TX 75390-8589; Tel: 214-648-4379, Fax: 214-648-4455; E-mail: taryn.mayes@utsouthwestern.edu.

References

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Do Children and Adolescents Have Differential Response Rates in Placebo-Controlled Trials of Fluoxetine?

  • Taryn L. Mayes, Rongrong Tao, Jeanne W. Rintelmann, Thomas Carmody, Carroll W. Hughes, Beth D. Kennard, Sunita M. Stewart and Graham J. Emslie...

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