A Randomized controlled trial of venlafaxine ER versus placebo in pediatric social anxiety disorder.
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.
March
John S
JS
Department of Psychiatry, Duke University Medical Center, Durham, North Carolina 27710, USA. jsmarch@acpub.duke.edu
Entusah
A Richard
AR
Rynn
Moira
M
Albano
Anne Marie
AM
Tourian
Karen A
KA
D000293:Adolescent; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy*; D002648:Child; D016001:Confidence Intervals; D003511:Cyclohexanols / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics; D011569:Psychiatric Status Rating Scales; D012044:Regression Analysis; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
D018687:Antidepressive Agents, Second-Generation; D003511:Cyclohexanols; D000069470:Venlafaxine Hydrochloride