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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ABSTRACT: Recent advances in the developmental epidemiology, neurobiology, and treatment of pediatric anxiety disorders have increased our understanding of these conditions and herald improved outcomes for affected children and adolescents. This article reviews the current epidemiology, longitudinal trajectory, and neurobiology of anxiety disorders in youth. Additionally, we summarize the current evidence for both psychotherapeutic and psychopharmacologic treatments of fear-based anxiety disorders (e.g., generalized, social, and separation anxiety disorders) in children and adolescents. Current data suggest that these disorders begin in childhood and adolescence, exhibit homotypic continuity, and increase the risk of secondary anxiety and mood disorders. Psychopharmacologic trials involving selective serotonin reuptake inhibitors (SSRIs) and selective serotonin norepinephrine reuptake inhibitors (SSNRIs) are effective in pediatric patients with anxiety disorders and have generally demonstrated moderate effect sizes. Additionally, current data support cognitive behavioral therapy (CBT) for the treatment of these conditions in youth and suggest that the combination of psychotherapy + an SSRI may be associated with greater improvement than would be expected with either treatment as monotherapy.Current Psychiatry Reports 07/2015; 17(7). DOI:10.1007/s11920-015-0591-z · 3.05 Impact Factor
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ABSTRACT: Social anxiety is the most prevalent anxiety disorder of late adolescence, yet current treatments reach only a minority of youth with the disorder. Effective and easy-to-disseminate treatments are needed. This study pilot tested the efficacy of a novel, online cognitive bias modification for interpretation (CBM-I) intervention for socially anxious youth and their parents. The CBM-I intervention targeted cognitive biases associated with early adolescents’ maladaptive beliefs regarding social situations, and with parents’ intrusive behavior, both of which have been theoretically linked with the maintenance of social anxiety in youth. To investigate the efficacy of intervening with parents and/or children, clinically diagnosed early adolescents (ages 10–15; N = 18) and their mothers were randomly assigned to one of three conditions: the first targeted early adolescents’ cognitive biases related to social anxiety (Child-only condition); the second targeted parents’ biases associated with intrusive behavior (Parent-only condition); and the third targeted both youth and parents’ biases in tandem (Combo condition). The use of a multiple baseline design allowed for the efficient assessment of causal links between the intervention and reduction in social anxiety symptoms in youth. Results provided converging evidence indicating modest support for the efficacy of CBM-I, with no reliable differences across conditions. Taken together, results suggest that online CBM-I with anxious youth and/or their parents holds promise as an effective and easily administered component of treatment for child social anxiety that deserves further evaluation in a larger trial.Journal of Anxiety Disorders 12/2014; 28(8). DOI:10.1016/j.janxdis.2014.09.011 · 2.96 Impact Factor
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ABSTRACT: Background Randomized controlled trials have demonstrated that antidepressants are efficacious in the treatment of anxiety disorders in youth. However, there are no recent, systematic analyses of the efficacy, safety, or tolerability of these medications in pediatric anxiety disorders.MethodsA systematic review and meta-analysis of prospective, randomized, parallel-group, controlled trials of selective serotonin reuptake inhibitors (SSRIs) and selective serotonin–norepinephrine reuptake inhibitors (SSNRIs) in pediatric patients with non-obsessive compulsive disorder (OCD) anxiety disorders was undertaken using a search of PubMed/Medline (1966–2014). The meta-analysis utilized random-effects models to evaluate change in the Pediatric Anxiety Rating Scale or similar anxiety scale, suicidality, and adverse events. Additionally, pharmacologic variables were explored with regard to effect size, although no correction for multiple comparisons was made with regard to these relationships.ResultsNine trials involving 1,673 patients and six medications were included. All SSRI/SSNRIs evaluated demonstrated efficacy, and the meta-analytic estimate of effect was of moderate magnitude (Cohen's d = 0.62, confidence interval [CI]: 0.34–0.89, P = .009) and there was evidence of modest heterogeneity (I2 = 0.29, P = .103). Activation trended toward being more likely with antidepressant treatment (OR: 1.86, CI: 0.98–3.53, P = .054), but no increased risk was observed for nausea/abdominal symptoms (P = .262), discontinuation as a result of an adverse event (P = .132), or suicidality (OR: 1.3, CI: 0.53–3.2, P = .514). Finally, the effect size correlated with the serotonergic specificity of the agent (R = .79, P = .021).Conclusions Data for nine SSRI/SSNRIs suggest superiority of antidepressants relative to placebo for the treatment of pediatric anxiety disorders with a moderate effect size.Depression and Anxiety 11/2014; 32(3). DOI:10.1002/da.22329 · 4.29 Impact Factor