Venlafaxine ER for the treatment of pediatric subjects with depression: results of two placebo-controlled trials.
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.


METHODS
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.
Emslie
Graham J
GJ
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA. Electronic address: graham.emslie@utsouthwestern.edu.
Findling
Robert L
RL
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA.
Yeung
Paul P
PP
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA.
Kunz
Nadia R
NR
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA.
Li
Yunfeng
Y
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA.
D000293:Adolescent; D000465:Algorithms; D002648:Child; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013406:Suicide, Attempted; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
D003511:Cyclohexanols; D003692:Delayed-Action Preparations; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride