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Study Fails to Find Paroxetine More Efficacious Than Placebo for Paediatric Major Depressive Disorder: Presented at AACAP
By Jerry Ingram
WASHINGTON, DC -- November 1, 2004 -- A randomized study of paroxetine for treatment of children and adolescents with major depressive disorder (MDD) failed to show that paroxetine is more efficacious than placebo.
Lead author Graham Emslie, MD, director, Child Psychiatry Program, University of Texas Southwestern Medical Center, Dallas, Texas, presented the findings here on October 20th at the American Academy of Child and Adolescent Psychiatry 51st Annual Meeting.
For this investigation, the researchers enrolled 206 patients between the ages of 7 and 17 years, and randomized 104 patients to receive paroxetine 10 to 50 mg/day and 102 to placebo for an 8-week period. They measured primary efficacy from baseline using the Children's Depression Rating Scale-revised (CDRS-R) total score at week 8 last observation carried forward end point. In addition they monitored for adverse events to assess for safety.
The difference between the two groups after 8 weeks was not statistically significant (95% CI 3.09, 4.69; P =.684). Patients treated with paroxetine had an adjusted mean CDRS-R total score change of -22.58 from baseline (SE 1.47) while those in the placebo group scored -23.38 points (SE 1.60).
Dizziness, cough, dyspepsia and vomiting were experienced more often in the paroxetine group than in the placebo group.
Additionally, the incidence of suicidal ideation and/or attempts at suicide was 2.9% of taking paroxetine compared to 1.0% of placebo patients (P =.345).
The researchers concluded that although children in the study tolerated paroxetine well, paroxetine was not more efficacious than placebo for treatment of MDD in this cohort.
[Presentation title: "Paroxetine Treatment in Children and Adolescent with Major Depressive Disorder." Poster B25]
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