NCT00052078

Child and Adolescent Anxiety Disorders (CAMS)

Child/Adolescent Anxiety Multimodal Treatment Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

Detailed description

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. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo. During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Conditions

• Anxiety Disorders
• Social Phobia
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Sertraline (SRT)	Participants were treated with sertraline.
BEHAVIORAL	Cognitive Behavioral Therapy (CBT)	Participants received CBT.
DRUG	Placebo	Participants were treated with a placebo pill.

Timeline

• Start date: 2003-01-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2003-01-23
• Last updated: 2017-09-19
• Results posted: 2017-04-25

Locations

6 sites across 1 country: United States