Child and Adolescent Anxiety Disorders (CAMS)
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorders; Social Phobia; Generalized Anxiety Disorder
Intervention: Sertraline (Drug); Cognitive Behavioral Therapy (CBT) (Behavioral); Placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Mental Health (NIMH)
Summary
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.
Clinical Details
Official title: Child/Adolescent Anxiety Multimodal Treatment Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: Evidence of clinically significant improvement as rated by blind evaluator
Secondary outcome: Anxiety symptoms rated by self and parent
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. 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.
Eligibility
Minimum age: 7 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
UCLA, Los Angeles, California, United States
Johns Hopkins, Baltimore, Maryland 21287, United States
NYSPI/Columbia University, New York, New York, United States
Duke University, Durham, North Carolina, United States
Temple University, Philadelphia, Pennsylvania, United States
University of Pittsburgh/WPIC, Pittsburgh, Pennsylvania, United States
Additional Information
Starting date: January 2003
Ending date: March 2008
Last updated: February 12, 2008
|
