NCT00043537

Brief Summary

This 4-year study will compare the long-term effectiveness of behavioral treatment, fluoxetine (Prozac®), and placebo for treatment of social phobia in children and adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

5.4 years

First QC Date

August 9, 2002

Last Update Submit

July 31, 2013

Conditions

Social Phobia

Keywords

Phobic DisordersMutism

Study Arms (3)

Social Effectiveness Therapy for Children

EXPERIMENTAL

Social Effectiveness Therapy for Children includes social skills training, peer generalization experiences and exposure therapy

Behavioral: Social Effectiveness Therapy for Children (SET-C)

Fluoxetine

EXPERIMENTAL

Fluoxetine given in 10mg doses, up to 40 mg as tolerated

Drug: Fluoxetine

Pill placebo

PLACEBO COMPARATOR

Capsules identical to fluoxetine given in "10 mg." doses up to 40 mg.

Drug: Pill Placebo

Interventions

Social Effectiveness Therapy for Children (SET-C)BEHAVIORAL
Social Effectiveness Therapy for Children
FluoxetineDRUG
Fluoxetine
Pill PlaceboDRUG
Pill placebo

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of social phobia

You may not qualify if:

  • Pervasive developmental disorders (PDD)
  • Schizophrenia
  • Major Depression
  • IQ of less than 80
  • Medical conditions contraindicating use of fluoxetine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Center for Anxiety Disorders

University of Maryland, College Park, Maryland, 20742, United States

Location

Related Publications (3)

  • Beidel DC, Turner SM, Sallee FR, Ammerman RT, Crosby LA, Pathak S. SET-C versus fluoxetine in the treatment of childhood social phobia. J Am Acad Child Adolesc Psychiatry. 2007 Dec;46(12):1622-32. doi: 10.1097/chi.0b013e318154bb57.

    PMID: 18030084RESULT

  • De Los Reyes A, Alfano CA, Beidel DC. Are clinicians' assessments of improvements in children's functioning "global"? J Clin Child Adolesc Psychol. 2011;40(2):281-94. doi: 10.1080/15374416.2011.546043.

    PMID: 21391024DERIVED

  • De Los Reyes A, Alfano CA, Beidel DC. The relations among measurements of informant discrepancies within a multisite trial of treatments for childhood social phobia. J Abnorm Child Psychol. 2010 Apr;38(3):395-404. doi: 10.1007/s10802-009-9373-6.

    PMID: 20013046DERIVED

MeSH Terms

Conditions

Phobia, SocialPhobic DisordersMutism

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

August 9, 2002

First Posted

August 12, 2002

Study Start

April 1, 2001

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations

US(1)