Venlafaxine ER for the treatment of pediatric subjects with depression

Results of two placebo-controlled trials

Graham J. Emslie, Robert L Findling, Paul P. Yeung, Nadia R. Kunz, Yunfeng Li

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: The safety, efficacy, and tolerability of venlafaxine extended release (ER) in subjects ages 7 to 17 years with major depressive disorder were evaluated in two multicenter, randomized, double-blind, placebo-controlled trials conducted between October 1997 and August 2001. METHOD: Participants received venlafaxine ER (flexible dose, based on body weight; intent to treat, n = 169) or placebo (intent to treat, n = 165) for up to 8 weeks. The primary efficacy variable was the change from baseline in the Children's Depression Rating Scale-Revised score at week 8. RESULTS: There were no statistically significant differences between venlafaxine ER and placebo on the Children's Depression Rating Scale-Revised in either study. A post hoc age subgroup analysis of the pooled data showed greater improvement on the Children's Depression Rating Scale-Revised with venlafaxine ER than with placebo (-24.4 versus -19.9; p = .022) among adolescents (ages 12-17), but not among children (ages 7-11). The most common adverse events were anorexia and abdominal pain. Hostility and suicide-related events were more common in venlafaxine ER-treated participants than in placebo-treated participants. There were no completed suicides. CONCLUSIONS: Venlafaxine ER may be effective in depressed adolescents. However, its safety and efficacy in pediatric patients has not been established. Prescribers should monitor for signs of suicidal ideation and hostility in pediatric patients taking venlafaxine ER. Copyright 2007

Original languageEnglish (US)
Pages (from-to)479-488
Number of pages10
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume46
Issue number4
DOIs
StatePublished - Apr 2007
Externally publishedYes

Fingerprint

Placebos
Depression
Pediatrics
Hostility
Suicide
Therapeutics
Safety
Suicidal Ideation
Major Depressive Disorder
Anorexia
Venlafaxine Hydrochloride
Abdominal Pain
Body Weight

Keywords

  • Controlled trial
  • Depression
  • Pediatric
  • Randomized
  • Serotonin norepinephrine reuptake inhibitor
  • Venlafaxine

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

Venlafaxine ER for the treatment of pediatric subjects with depression : Results of two placebo-controlled trials. / Emslie, Graham J.; Findling, Robert L; Yeung, Paul P.; Kunz, Nadia R.; Li, Yunfeng.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 46, No. 4, 04.2007, p. 479-488.

Research output: Contribution to journalArticle

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