A Randomized Controlled Trial of Venlafaxine ER Versus Placebo in Pediatric Social Anxiety Disorder
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  0.82 128 (6–17) 8 weeks Fluvoxamine CGI#2 19/65 (29%) Yes Birmaher et al. 2003  0.89 74 (7–17) 12 weeks Fluoxetine CGI#2 13/37 (35%) Yes Wagner et al. 2004  0.95 322 (8–17) 16 weeks Paroxetine CGI#2 59/154 (38%) Yes Rynn et al. 2007  0.82 323 (6–17) 8 weeks Venlafaxine CGI#2 77/159 (48%) Yes March et al. 2007  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 "
ABSTRACT: In a previous report, we hypothesized that responses to placebo were high in child and adolescent depression because of specific psychopathological factors associated with youth major depression. The purpose of this study was to compare the placebo response rates in pharmacological trials for major depressive disorder (MDD), obsessive compulsive disorder (OCD) and other anxiety disorders (AD-non-OCD). We reviewed the literature relevant to the use of psychotropic medication in children and adolescents with internalized disorders, restricting our review to double-blind studies including a placebo arm. Placebo response rates were pooled and compared according to diagnosis (MDD vs. OCD vs. AD-non-OCD), age (adolescent vs. child), and date of publication. From 1972 to 2007, we found 23 trials that evaluated the efficacy of psychotropic medication (mainly non-tricyclic antidepressants) involving youth with MDD, 7 pertaining to youth with OCD, and 10 pertaining to youth with other anxiety disorders (N = 2533 patients in placebo arms). As hypothesized, the placebo response rate was significantly higher in studies on MDD, than in those examining OCD and AD-non-OCD (49.6% [range: 17-90%] vs. 31% [range: 4-41%] vs. 39.6% [range: 9-53], respectively, ANOVA F = 7.1, p = 0.002). Children showed a higher stable placebo response within all three diagnoses than adolescents, though this difference was not significant. Finally, no significant effects were found with respect to the year of publication. MDD in children and adolescents appears to be more responsive to placebo than other internalized conditions, which highlights differential psychopathology.PLoS ONE 02/2008; 3(7):e2632. DOI:10.1371/journal.pone.0002632 · 3.53 Impact Factor
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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. "
ABSTRACT: Cited By (since 1996): 14, Export Date: 23 July 2012, Source: Scopus, CODEN: PCONF, Language of Original Document: Spanish, Correspondence Address: García-López, L. J.; Dpto. de Personalidad, Evaluación y Tratamiento Psicológico, Universidad de Granada, 18071 Granada, Spain; email: firstname.lastname@example.org, References: Albano, A. M. y Detweiler, M. F. (2001). The developmental and clinical impact of social anxiety and social phobia in children and adolescents. En S. G. Hofmann y P. M. DiBartolo (dirs.), From social anxiety to social phobia (pp. 162-178). Massachusetts: Allyn & BaconAlbano, A.M., DiBartolo, P.M., (2007) Cognitive behavioral therapy for social phobia in adolescents: Stand up, speak out therapist guide, , Nueva York: Oxford University Press;Behavioral Psychology/Psicologia Conductual 01/2008; 16(3-3):501-533. · 0.83 Impact Factor
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ABSTRACT: Psychopharmacologic agents may offer potentially effective treatment of child and adolescent anxiety disorders. Much further research, however, remains to be done to determine medication specificity, dosages, duration of treatment, and the optimal relationship between pharmacologic and nonpharmacologic therapies.Psychiatric Clinics of North America 04/1992; 15(1):41-67. · 2.13 Impact Factor