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Treatment of Childhood Social Phobia

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00043537
First received: August 9, 2002
Last updated: February 28, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Social Phobia
 Behavioral: Social Effectiveness Therapy for Children (SET-C)
Drug: Fluoxetine
Drug: Pill Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Childhood Social Phobia

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias
U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 250
Study Start Date: April 2001
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Social phobia affects 3-5 percent of children, and prevalence rises with age. Youth with social phobia fear many activities that are part of everyday life and suffer from problems such as headaches or stomachaches, panic, avoidance, general anxiety, depression, loneliness, and a very restricted range of social relationships. Recent findings indicate a new psychosocial treatment called Social Effectiveness Therapy for Children (SET-C) is effective in treating children ages 8-11, resulting in reduced emotional distress and improved social functioning. Treatment effects have been maintained for up to 6 months. This study will examine SET-C in children ages 8-15. Because available data suggest that the drug fluoxetine is a promising treatment, SET-C will be compared to fluoxetine in this trial. Durability of treatment will be monitored over a 1-year follow-up period.

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of social phobia

Exclusion Criteria:

  • Pervasive developmental disorders (PDD)
  • Schizophrenia
  • Major Depression
  • IQ of less than 80
  • Medical conditions contraindicating use of fluoxetine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043537

Locations
United States, Maryland
Maryland Center for Anxiety Disorders
University of Maryland, College Park, Maryland, United States, 20742
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00043537     History of Changes
Other Study ID Numbers: R01 MH53703, DSIR CT-CT
Study First Received: August 9, 2002
Last Updated: February 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Phobic Disorders
Mutism

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013