The purpose of this study is to compare the effectiveness of interventions for children and adolescents with separation anxiety disorder, social phobia, and/or generalized anxiety disorder. This study will also determine how long the treatment effects last.

Condition	Treatment or Intervention	Phase
Anxiety Disorders	Drug: sertraline (Zoloft)  Behavior: Cognitive Behavioral Therapy	Phase III

Further Study Details: 

Expected Total Enrollment:  318

Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Effective treatments that alleviate symptoms and prevent long-term morbidity and mortality associated with childhood-onset anxiety disorders are needed.

During Phase I of this two-phase study, participants are randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involves a 6-month maintenance period for participants that respond to any of the three active treatments.

Ages Eligible for Study:  7 Years   -   17 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria:

• Major neurological disorder or medical illness that would interfere with participation in the study

Sam Walford, M.A.      410-955-1542    swalford@jhmi.edu
Hyung Koo, R.N.      410-614-4001    hkoo@jhmi.edu

California
      UCLA, Los Angeles,  California,  United States; Recruiting
Maryland
      Johns Hopkins, Baltimore,  Maryland,  21287,  United States; Recruiting
New York
      New York University, New York,  New York,  United States; Recruiting
      NYSPI/Columbia University, New York,  New York,  United States; Recruiting
North Carolina
      Duke University, Durham,  North Carolina,  United States; Recruiting
Pennsylvania
      Temple University/University of Pennsylvania, Philadelphia,  Pennsylvania,  United States; Recruiting
      University of Pittsburgh/WPIC, Pittsburgh,  Pennsylvania,  United States; Recruiting

Study ID Numbers:  64089-01A1
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  January 22, 2003
ClinicalTrials.gov Identifier:  NCT00052078
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08