Abstract | 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: 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:
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Authors | Karen Dineen Wagner, Ray Berard, Murray B Stein, Erica Wetherhold, David J Carpenter, Phillip Perera, Michelle Gee, Katherine Davy, Andrea Machin |
Journal | Archives of general psychiatry
(Arch Gen Psychiatry)
Vol. 61
Issue 11
Pg. 1153-62
(Nov 2004)
ISSN: 0003-990X [Print] United States |
PMID | 15520363
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Placebos
- Serotonin Uptake Inhibitors
- Paroxetine
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Topics |
- Adolescent
- Age Factors
- Ambulatory Care
- Child
- Double-Blind Method
- Drug Administration Schedule
- Feeding and Eating Disorders
(chemically induced)
- Female
- Humans
- Male
- Paroxetine
(administration & dosage, adverse effects, therapeutic use)
- Personality Inventory
- Phobic Disorders
(diagnosis, drug therapy, psychology)
- Placebos
- Psychiatric Status Rating Scales
- Selective Serotonin Reuptake Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Sleep Initiation and Maintenance Disorders
(chemically induced)
- Treatment Outcome
- Vomiting
(chemically induced)
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