Cartilage Disorders |
Costochondritis; Polychondritis |
Clinical Trial: Treatment of Childhood Social Phobia
This study is currently recruiting patients.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Phobic Disorders | Behavior: Social Effectiveness Therapy for Children (SET-C) Drug: Fluoxetine Drug: Pill Placebo | Phase III |
MedlinePlus related topics: Phobias
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 250
Study start: April 2001
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 - 16 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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
Location and Contact Information
Maryland
Maryland Center for Anxiety Disorders, University of Maryland, College Park, Maryland, 20742, United States; Recruiting
Deborah C Beidel, Ph.D., Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 7, 2005
Record first received: August 9, 2002
ClinicalTrials.gov Identifier: NCT00043537
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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