 |
|
A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial of Paroxetine in Children and Adolescents With Social Anxiety Disorder
Karen Dineen Wagner, MD, PhD;
Ray Berard, MMed, FCPsych(SA);
Murray B. Stein, MD, MPH;
Erica Wetherhold, BSN;
David J. Carpenter, MS, RPh;
Phillip Perera, MD;
Michelle Gee, PhD;
Katherine Davy, MSc;
Andrea Machin, MSc
Arch Gen Psychiatry. 2004;61:1153-1162.
Background Social anxiety disorder is a debilitating, highly prevalent disorder in children and adolescents. If left untreated, it can interfere with emotional, social, and school functioning.
Objective To evaluate the efficacy and tolerability of paroxetine in children and adolescents with social anxiety disorder.
Design and Setting Multicenter, 16-week, randomized, double-blind, placebo-controlled, flexible-dose, parallel-group, outpatient study.
Patients A total of 322 children (8-11 years of age) and adolescents (12-17 years of age) with social anxiety disorder as their predominant psychiatric illness.
Intervention Eligible patients were randomized (1:1) to receive paroxetine (10-50 mg/d) or placebo.
Results Four hundred twenty-five patients were screened, and 322 were randomized to treatment. Of these, 319 were included in the intention-to-treat population (paroxetine, n = 163; placebo, n = 156). At the week 16 last observation carried forward end point, the odds of responding (Clinical Global Impression-Improvement score of 1 or 2) were statistically significantly greater for paroxetine (77.6% response [125/161]) than for placebo (38.3% response [59/154]) (adjusted odds ratio, 7.02; 95% confidence interval, 4.07 to 12.11; P<.001). The proportion of patients who were "very much" improved (Clinical Global Impression-Improvement score of 1) was 47.8% (77/161) for paroxetine compared with 14.9% (23/154) for placebo. Adverse events occurring at an incidence of 5% or greater for paroxetine and twice that for placebo were insomnia (14.1% vs 5.8%), decreased appetite (8.0% vs 3.2%), and vomiting (6.7% vs 1.9%). Withdrawals due to adverse events were infrequent (5.5% [9/163] for paroxetine and 1.3% [2/156] for placebo).
Conclusion Paroxetine is an effective, generally well-tolerated treatment for pediatric social anxiety disorder.
Author Affiliations: University of Texas Medical Branch, Galveston (Dr Wagner); University of Cape Town Medical School/Groote Schuur Hospital, Cape Town, South Africa (Dr Berard); University of California San Diego, La Jolla (Dr Stein); GlaxoSmithKline Pharmaceuticals, King of Prussia, Pa (Ms Wetherhold, Mr Carpenter, and Dr Perera); and GlaxoSmithKline Pharmaceuticals, New Frontiers Science Park, Harlow, England (Dr Gee and Mss Davy and Machin).
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati  Twitter
What's this?
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood Anxiety
Walkup et al.
NEJM 2008;359:2753-2766.
ABSTRACT
| FULL TEXT
Clinical Response and Risk for Reported Suicidal Ideation and Suicide Attempts in Pediatric Antidepressant Treatment: A Meta-analysis of Randomized Controlled Trials
Bridge et al.
JAMA 2007;297:1683-1696.
ABSTRACT
| FULL TEXT
Should Selective Serotonin Reuptake Inhibitors Be Prescribed for Children With Major Depressive and Anxiety Disorders?
Safer
Pediatrics 2006;118:1248-1251.
FULL TEXT
Brief Measures to Screen for Social Phobia in Primary Care Pediatrics
Bailey et al.
J Pediatr Psychol 2006;31:512-521.
ABSTRACT
| FULL TEXT
Evidence-based guidelines for the pharmacological treatment of anxiety disorders: recommendations from the British Association for Psychopharmacology
Baldwin et al.
J Psychopharmacol 2005;19:567-596.
ABSTRACT
Paroxetine improves social anxiety disorder in children and adolescents
Manassis
Evid. Based Ment. Health 2005;8:43-43.
FULL TEXT
A Way to Treat Social Anxiety in Children
JWatch Psychiatry 2004;2004:5-5.
FULL TEXT
|
