Background
Social anxiety disorder, which occurs in 2% to 5% of children and adolescents, is
associated with significant distress and functional impairment.
Methods
The objective of the randomized, masked controlled trial conducted in 48 academic
and community centers in the United States was to evaluate the efficacy of venlafaxine
ER in children and adolescents with generalized social anxiety disorder. A volunteer
sample of 293 outpatients, age 8 to 17, who met diagnostic criteria for social anxiety
disorder and were enrolled between February 2000 and March 2003 participated. Venlafaxine
ER or placebo was titrated from a starting dose of 37.5 mg to a maximum dose of 225
mg over 16 weeks. The primary dependent measures were the Social Anxiety Scale, child
or adolescent version (SAS-CA) and for responder analysis, a (dichotomized) Clinical
Global Impressions-Improvement (CGI-I) score.
Results
Compared with placebo, intent-to-treat random regression analyses indicated a statistically
significant advantage for venlafaxine ER (p = .001) on the SAS-CA. On the CGI-I responder analysis, 56% (95% confidence interval
[CI], 47%-64%) of venlafaxine ER treated subjects responded, which was statistically
superior to placebo (37% [95% CI, 29%-45%]). Three venlafaxine ER and no placebo patients
developed treatment-emergent suicidality; there were no completed suicides.
Conclusions
Venlafaxine ER is an effective and reasonably well-tolerated treatment for generalized
social anxiety disorder in children and adolescents. As with other antidepressants,
careful clinical monitoring for adverse events, including treatment-emergent suicidality,
is essential.
Key Words
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Article info
Publication history
Published online: June 06, 2007
Accepted:
February 21,
2007
Received in revised form:
February 9,
2007
Received:
December 4,
2006
Identification
Copyright
© 2007 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
