A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial ofParoxetine in Children and Adolescents With Social Anxiety Disorder | Adolescent Medicine | JAMA Psychiatry | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
Stein  MBFuetsch  MMuller  NHofler  MLieb  RWittchen  HU Social anxiety disorder and the risk of depression: a prospective communitystudy of adolescents and young adults.  Arch Gen Psychiatry 2001;58251- 256PubMedGoogle ScholarCrossref
Anderson  JCWilliams  SMcGee  RSilva  PA DSM-III disorders in preadolescent children:prevalence in a large sample from the general population.  Arch Gen Psychiatry 1987;4469- 76PubMedGoogle ScholarCrossref
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition.  Washington, DC American Psychiatric Association1994;
Spence  SHDonovan  CBrechman-Toussaint  M Social skills, social outcomes, and cognitive features of childhoodsocial phobia.  J Abnorm Psychol 1999;108211- 221PubMedGoogle ScholarCrossref
Beidel  DCTurner  SMMorris  TL Psychopathology of childhood social phobia.  J Am Acad Child Adolesc Psychiatry 1999;38643- 650PubMedGoogle ScholarCrossref
Stein  MBChavira  DAJang  KL Bringing up bashful baby: developmental pathways to social phobia.  Psychiatr Clin North Am 2001;24661- 675PubMedGoogle ScholarCrossref
Woodward  LJFergusson  DM Life course outcomes of young people with anxiety disorders in adolescence.  J Am Acad Child Adolesc Psychiatry 2001;401086- 1093PubMedGoogle ScholarCrossref
Pine  DSCohen  PGurley  DBrook  JMa  Y The risk for early-adulthood anxiety and depressive disorders in adolescentswith anxiety and depressive disorders.  Arch Gen Psychiatry 1998;5556- 64PubMedGoogle ScholarCrossref
Schneier  FRHeckelman  LRGarfinkel  RCampeas  RFallon  BAGitow  AStreet  LDel Bene  DLiebowitz  MR Functional impairment in social phobia.  J Clin Psychiatry 1994;55322- 331PubMedGoogle Scholar
Safren  SAHeimberg  RGJuster  HR Clients’ expectancies and their relationship to pretreatmentsymptomatology and outcome of cognitive-behavioral group treatment for socialphobia.  J Consult Clin Psychol 1997;65694- 698PubMedGoogle ScholarCrossref
Stein  MBLiebowitz  MRLydiard  RBPitts  CDBushnell  WGergel  I Paroxetine treatment of generalized social phobia (social anxiety disorder):a randomized controlled trial.  JAMA 1998;280708- 713PubMedGoogle ScholarCrossref
Connor  KMDavidson  JRTChung  HClary  CYang  R Efficacy of sertraline in two randomized, placebo-controlled, double-blind,multicenter trials for social phobia (social anxiety disorder): combined results.  Eur Neuropsychopharmacol 2002;12S350Google ScholarCrossref
Stein  MB Long-term treatment of generalized social anxiety disorder with venlafaxineXR.  Paper presented at: 23rd Annual Conference of the Anxiety DisordersAssociation of America March 29, 2003 Toronto, Ontario
Mangano  RM Treating social anxiety disorder with venlafaxine extended release.  Eur Neuropsychopharmacol 2002;12S358Google ScholarCrossref
Compton  SNGrant  PJChrisman  AKGammon  PJBrown  VLMarch  JS Sertraline in children and adolescents with social anxiety disorder:an open trial.  J Am Acad Child Adolesc Psychiatry 2001;40564- 571PubMedGoogle ScholarCrossref
Chavira  DAStein  MB Combined psychoeducation and treatment with selective serotonin reuptakeinhibitors for youth with generalized social anxiety disorder.  J Child Adolesc Psychopharmacol 2002;1247- 54PubMedGoogle ScholarCrossref
Birmaher  BWaterman  GSRyan  NCully  MBalach  LIngram  JBrodsky  M Fluoxetine for childhood anxiety disorders.  J Am Acad Child Adolesc Psychiatry 1994;33993- 999PubMedGoogle ScholarCrossref
Fairbanks  JMPine  DSTancer  NKDummit  ESIKentgen  LMMartin  JAsche  BKKlein  RG Open fluoxetine treatment of mixed anxiety disorders in children andadolescents.  J Child Adolesc Psychopharmacol 1997;717- 29PubMedGoogle ScholarCrossref
Birmaher  BAxelson  DAMonk  KKalas  CClark  DBEhmann  MBridge  JHeo  JBrent  DA Fluoxetine for the treatment of childhood anxiety disorders.  J Am Acad Child Adolesc Psychiatry 2003;42415- 423PubMedGoogle ScholarCrossref
Research Unit on Pediatric Psychopharmacology Anxiety Study Group, Fluvoxamine for the treatment of anxiety disorders in children andadolescents.  N Engl J Med 2001;3441279- 1285PubMedGoogle ScholarCrossref
Silverman  WKAlbano  AM The Anxiety Disorders Interview Schedule for Childrenfor DSM-IV: Child And Parent Versions.  Boulder, Colo Graywind Publications Ltd1996;
Stein  MChavira  DMorris  TL Social Anxiety Disorder in Children and Adolescents:A Guide for Parents.  Philadelphia, Pa SmithKline Beecham2000;
Stein  MChavira  DMorris  TL Social Anxiety Disorder: A Guide for Adolescents.  Philadelphia, Pa SmithKline Beecham2000;
Stein  MChavira  DMorris  TL Social Anxiety Disorder: A Guide for Children.  Philadelphia, Pa SmithKline Beecham2000;
Masia-Warner  CStorch  EAPincus  DBKlein  RGHeimberg  RHLiebowitz  MR The Liebowitz Social Anxiety Scale for Children and Adolescents: aninitial psychometric investigation.  J Am Acad Child Adolesc Psychiatry 2003;421076- 1084PubMedGoogle ScholarCrossref
Turner  SMBeidel  DCMorris  TL Social Phobia and Anxiety Inventory for Children(SPAI-C).  North Tonawanda, NY Multi-Health Systems Inc1998;
Brooks  SJKutcher  S The Kutcher Generalized Social Anxiety Disorder Scale for Adolescents:assessment of its evaluative properties over the course of a 16-week pediatricpsychopharmacotherapy trial.  J Child Adolesc Psychopharmacol 2004;14273- 286Google ScholarCrossref
Guy  W ECDEU Assessment Manual for Psychopharmacology Revised.  Washington, DC US Department of Health, Education, and Welfare1976;
Turner  SMBeidel  DCDancu  CV Social Phobia and Anxiety Inventory (Manual).  North Tonawanda, NY Multi-Health Systems Inc1996;
Ballenger  JC Clinical guidelines for establishing remission in patients with depressionand anxiety.  J Clin Psychiatry 1999;60 ((suppl 22)) 29- 34PubMedGoogle ScholarCrossref
Bourdon  KHRae  DSLocke  BZNarrow  WERegier  DA Estimating the prevalence of mental disorders in US adults from theEpidemiologic Catchment Area Survey.  Public Health Rep 1992;107663- 668Google Scholar
Essau  CAConradt  JPetermann  F Frequency and comorbidity of social phobia and social fears in adolescents.  Behav Res Ther 1999;37831- 843PubMedGoogle ScholarCrossref
Wittchen  HUStein  MBKessler  RC Social fears and social phobia in a community sample of adolescentsand young adults: prevalence, risk factors and co-morbidity.  Psychol Med 1999;29309- 323PubMedGoogle ScholarCrossref
Olfson  MMarcus  SCWeissman  MMJensen  PS National trends in the use of psychotropic medications by children.  J Am Acad Child Adolesc Psychiatry 2002;41514- 521PubMedGoogle ScholarCrossref
Zito  JMSafer  DJDosReis  SGardner  JFMagder  LSoeken  KBoles  MLynch  FRiddle  MA Psychotropic practice patterns for youth: a 10-year perspective.  Arch Pediatr Adolesc Med 2003;15717- 25PubMedGoogle ScholarCrossref
Albano  AMMarten  PAHolt  CSHeimberg  RGBarlow  DH Cognitive-behavioral group treatment for social phobia in adolescents.a preliminary study.  J Nerv Ment Dis 1995;183649- 656PubMedGoogle ScholarCrossref
Beidel  DCTurner  SMMorris  TL Behavioral treatment of childhood social phobia.  J Consult Clin Psychol 2000;681072- 1080PubMedGoogle ScholarCrossref
Hayward  CVarady  SAlbano  AMThienemann  MHenderson  LSchatzberg  AF Cognitive-behavioral group therapy for social phobia in female adolescents:results of a pilot study.  J Am Acad Child Adolesc Psychiatry 2000;39721- 726PubMedGoogle ScholarCrossref
Shortt  ALBarrett  PMFox  TL Evaluating the FRIENDS program: a cognitive-behavioral group treatmentfor anxious children and their parents.  J Clin Child Psychol 2001;30525- 535PubMedGoogle ScholarCrossref
Spence  SHDonovan  CBrechman-Toussaint  M The treatment of childhood social phobia: the effectiveness of a socialskills training-based, cognitive-behavioural intervention, with and withoutparental involvement.  J Child Psychol Psychiatry 2000;41713- 726PubMedGoogle ScholarCrossref
Original Article
November 2004

A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial ofParoxetine in Children and Adolescents With Social Anxiety Disorder

Author Affiliations

Author Affiliations: University of Texas MedicalBranch, Galveston (Dr Wagner); University of Cape Town Medical School/GrooteSchuur Hospital, Cape Town, South Africa (Dr Berard); University of CaliforniaSan 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).

Arch Gen Psychiatry. 2004;61(11):1153-1162. doi:10.1001/archpsyc.61.11.1153

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.