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A multicenter, randomized, double-blind, placebo-controlled trial of paroxetine in children and adolescents with social anxiety disorder.
Arch Gen Psychiatry. 2004 Nov; 61(11):1153-62.AG

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

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.

Authors+Show Affiliations

University of Texas Medical Branch, Galveston, TX, USA. kwagner@utmb.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15520363

Citation

Wagner, Karen Dineen, et al. "A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Paroxetine in Children and Adolescents With Social Anxiety Disorder." Archives of General Psychiatry, vol. 61, no. 11, 2004, pp. 1153-62.
Wagner KD, Berard R, Stein MB, et al. A multicenter, randomized, double-blind, placebo-controlled trial of paroxetine in children and adolescents with social anxiety disorder. Arch Gen Psychiatry. 2004;61(11):1153-62.
Wagner, K. D., Berard, R., Stein, M. B., Wetherhold, E., Carpenter, D. J., Perera, P., Gee, M., Davy, K., & Machin, A. (2004). A multicenter, randomized, double-blind, placebo-controlled trial of paroxetine in children and adolescents with social anxiety disorder. Archives of General Psychiatry, 61(11), 1153-62.
Wagner KD, et al. A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Paroxetine in Children and Adolescents With Social Anxiety Disorder. Arch Gen Psychiatry. 2004;61(11):1153-62. PubMed PMID: 15520363.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, randomized, double-blind, placebo-controlled trial of paroxetine in children and adolescents with social anxiety disorder. AU - Wagner,Karen Dineen, AU - Berard,Ray, AU - Stein,Murray B, AU - Wetherhold,Erica, AU - Carpenter,David J, AU - Perera,Phillip, AU - Gee,Michelle, AU - Davy,Katherine, AU - Machin,Andrea, PY - 2004/11/3/pubmed PY - 2004/12/16/medline PY - 2004/11/3/entrez SP - 1153 EP - 62 JF - Archives of general psychiatry JO - Arch Gen Psychiatry VL - 61 IS - 11 N2 - 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. SN - 0003-990X UR - https://www.unboundmedicine.com/medline/citation/15520363/A_multicenter_randomized_double_blind_placebo_controlled_trial_of_paroxetine_in_children_and_adolescents_with_social_anxiety_disorder_ L2 - https://jamanetwork.com/journals/jamapsychiatry/fullarticle/10.1001/archpsyc.61.11.1153 DB - PRIME DP - Unbound Medicine ER -