Child and Adolescent Anxiety Disorders (CAMS)

Phase 3

Completed

• Conditions: Social Phobia; Generalized Anxiety Disorder; Anxiety Disorders
• Interventions: Drug: Sertraline (SRT); Drug: Placebo; Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT00052078
• Lead Sponsor: Johns Hopkins University

Brief 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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-01-22
• Study First Submitted QC: 2003-01-22
• Study First Posted: 2003-01-23
• Primary Completion: 2007-10
• Study Completion: 2008-03
• Results First Submitted: 2016-07-29
• Results First Submitted QC: 2017-03-14
• Results First Posted: 2017-04-25
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Sertraline	Sertraline (SRT)	Participants received sertraline for 12 weeks.
SRT + CBT	Sertraline (SRT)	Participants received both sertraline and CBT for 12 weeks.
SRT + CBT	Cognitive Behavioral Therapy (CBT)	Participants received both sertraline and CBT for 12 weeks.
CBT	Cognitive Behavioral Therapy (CBT)	Participants received cognitive behavioral therapy for 12 weeks
Placebo	Placebo	Participants received a placebo pill for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression - Improvement Scale	Measured at Week 12	The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.

Trial Locations

Locations (6)

NYSPI/Columbia University; 🇺🇸 New York, New York, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh/WPIC; 🇺🇸 Pittsburgh, Pennsylvania, United States