Official Title: “Child/Adolescent Anxiety Multimodal Treatment Study”

This 9-month study will compare the effectiveness of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: October 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • Participants will take sertraline for 12 weeks.
• Behavioral: Cognitive Behavioral Therapy (CBT)
  • Participants will receive CBT for 12 weeks.
• Drug: Placebo
  • Participants will take placebo capsules for 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive sertraline for 12 weeks
• Experimental: 2
  • Participants will receive cognitive behavioral therapy for 12 weeks
• Experimental: 3
  • Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
• Placebo Comparator: 4
  • Participants will receive placebo for 12 weeks

Primary Measures

• Evidence of clinically significant improvement as rated by blind evaluator
  • Time Frame: Measured at Week 12
    Safety Issue?: No

Secondary Measures

• Anxiety symptoms rated by self and parent
  • Time Frame: Measured at Week 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Mental Health (NIMH)

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00052078

Study ID Number: U01 MH64089

ClinicalTrials.gov Identifier: NCT00052078

Health Authority: United States: Federal Government