Phase 3
N=488
Child and Adolescent Anxiety Disorders (CAMS)
Anxiety Disorders · Social Phobia · Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00052078 ↗Enrolled (actual)
488
Serious AEs
0.6%
Results posted
Apr 2017
Primary outcome: Primary: Clinical Global Impression - Improvement Scale — 54.9; 59.7; 80.7; 23.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sertraline (SRT) (Drug); Cognitive Behavioral Therapy (CBT) (Behavioral); Placebo (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression - Improvement Scale |
54.9; 59.7; 80.7; 23.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnostic and Statistical Manual of Mental Disorders (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
Data sourced from ClinicalTrials.gov (NCT00052078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.