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

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.

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

Deborah C Beidel, Ph.D.      301-405-0232 

Maryland
      Maryland Center for Anxiety Disorders, University of Maryland, College Park,  Maryland,  20742,  United States; Recruiting

Study ID Numbers:  53703-05A2
Record last reviewed:  September 2004
Record first received:  August 9, 2002
ClinicalTrials.gov Identifier:  NCT00043537
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27