A Randomized Controlled Trial of Venlafaxine ER Versus Placebo in Pediatric Social Anxiety Disorder

Department of Psychiatry, Duke University Medical Center, Durham, North Carolina 27710, USA.
Biological Psychiatry (Impact Factor: 10.25). 12/2007; 62(10):1149-54. DOI: 10.1016/j.biopsych.2007.02.025
Source: PubMed

ABSTRACT Social anxiety disorder, which occurs in 2% to 5% of children and adolescents, is associated with significant distress and functional impairment.
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.
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.
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.

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    • "0.93 22 (5–17) 9 weeks Sertraline CGI#2 1/11 (9%) Yes RUPP 2001 [102] 0.82 128 (6–17) 8 weeks Fluvoxamine CGI#2 19/65 (29%) Yes Birmaher et al. 2003 [103] 0.89 74 (7–17) 12 weeks Fluoxetine CGI#2 13/37 (35%) Yes Wagner et al. 2004 [104] 0.95 322 (8–17) 16 weeks Paroxetine CGI#2 59/154 (38%) Yes Rynn et al. 2007 [105] 0.82 323 (6–17) 8 weeks Venlafaxine CGI#2 77/159 (48%) Yes March et al. 2007 [106] 0.95 293 (8–17) 16 weeks Venlafaxine CGI#2 54/148 (37%) Yes * and Boulos et al, 1992; **and Berard et al, 2006; a "
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    • "Existen otros muchos fármacos que debido a los pocos estudios existentes todavía no se pueden tener en cuenta como posible tratamiento farmacológico. Por ejemplo, existe un estudio que muestra resultados positivos y buena tolerancia con venlafaxina, de liberación prolongada (inhibidor de la recaptación de la serotonina y la norepinefrina) (March et al., 2007). El estudio ha mostrado que la venlafaxina es un tratamiento razonablemente bien tolerado y eficaz para el tratamiento del TAS infantil y adolescente. "
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