Analysis of electrocardiographic data following use of paroxetine in pediatric depression and obsessive-compulsive disorder

Stan Krulewicz, David J. Carpenter, Regan Fong, Joseph P. Horrigan, Alan Lipschitz, Philip Perera, Karen Dineen Wagner

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

Objective: This retrospective analysis of electrocardiographic (ECG) data investigated the cardiovascular effects of paroxetine 10-50 mg/day in pediatric patients (7-18 years of age). Data were collected from three 8- to 10-week, randomized, placebo-controlled, double-blind trials of paroxetine in pediatric patients with major depressive disorder or obsessive-compulsive disorder. Method: Electrocardiograms (ECGs) were retrospectively retrieved from 63 study sites in the United States and Canada. Only patients with at least one screening and one on-treatment ECG were included. ECGs were analyzed for heart rate, QT interval corrected using Bazett's formula (QTcB) and Fridericia's formula (QTcF), at screening and while being treated. PR, R-R, and QRS intervals and the maximum change in QTcB and QTcF from screening to endpoint were determined. Clinically significant thresholds were defined a priori. Results: A total of 1,451 ECGs from 449 patients receiving placebo (n = 207), paroxetine (n = 200), or imipramine (n = 42) were analyzed. Treatment with paroxetine did not significantly increase QTcB or QTcF or any ECG parameters compared with placebo. Treatment with imipramine significantly increased heart rate and QTcB, R-R, and QRS intervals compared with either paroxetine or placebo. Conclusions: Data from this retrospective study indicate that paroxetine (10-50 mg/day) is unlikely to be associated with significant ECG changes in medically healthy pediatric patients.

Original languageEnglish (US)
Pages (from-to)422-430
Number of pages9
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume45
Issue number4
DOIs
StatePublished - Apr 1 2006

Keywords

  • Electrocardiogram
  • Major depressive disorder
  • Obsessive-compulsive disorder
  • Paroxetine
  • Pediatric

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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