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

Department of Psychiatry, Columbia University, New York, New York, United States
Biological Psychiatry (Impact Factor: 10.26). 12/2007; 62(10):1149-54. DOI: 10.1016/j.biopsych.2007.02.025
Source: PubMed


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.

2 Reads
  • Source
    • "In addition to selective serotonin reuptake inhibitors, a serotonin-norepinephrine reuptake inhibitor, venlafaxine, has also been shown to be effective in treating anxiety disorders in youth. In a randomized, placebo-controlled trial in children aged 8–17 years with social phobia, March et al76 found venlafaxine extended-release to be associated with significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale. Similarly, Rynn et al77 found venlafaxine extended-release to be superior to placebo in reducing anxiety symptoms in youth with generalized anxiety disorder as compared with placebo in a randomized, controlled trial. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Anxiety disorders are the most prevalent mental health concern facing adolescents today, yet they are largely undertreated. This is especially concerning given that there are fairly good data to support an evidence-based approach to the diagnosis and treatment of anxiety, and also that untreated, these problems can continue into adulthood, growing in severity. Thus, knowing how to recognize and respond to anxiety in adolescents is of the utmost importance in primary care settings. To that end, this article provides an up-to-date review of the diagnosis and treatment of anxiety disorders geared towards professionals in primary care settings. Topics covered include subtypes, clinical presentation, the etiology and biology, effective screening instruments, evidence-based treatments (both medication and therapy), and the long-term prognosis for adolescents with anxiety. Importantly, we focus on the most common types of anxiety disorders, often known as phobias, which include generalized anxiety disorder, social anxiety/social phobia, separation anxiety disorder, panic disorder, and specific phobias. In summary, anxiety is a common psychiatric problem for adolescents, but armed with the right tools, primary care providers can make a major impact.
    Preview · Article · Jan 2012 · Adolescent Health, Medicine and Therapeutics
  • Source
    • "Pharmacological treatment in children and adolescents is supported by data suggesting the continuity of childhood anxiety disorders with adult anxiety and depressive disorders [32-35] and efficacy of a range of antidepressant medications in the treatment of adult anxiety disorders, including SSRIs [36]. Prior to CAMS, controlled trials of SSRIs in childhood anxiety disorders support the short-term efficacy and safety of these compounds for the disorders targeted in CAMS, [21-24] as well as for selective mutism[33] and OCD [35,37]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. NCT00052078.
    Full-text · Article · Jan 2010 · Child and Adolescent Psychiatry and Mental Health
  • Source
    • "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. "
    [Show abstract] [Hide abstract]
    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:, 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;
    Full-text · Article · Dec 2008 · Behavioral Psychology/Psicologia Conductual
Show more