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Child and Adolescent Anxiety Disorders (CAMS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was:  Active, not recruiting
Information provided by:
National Institute of Mental Health (NIMH) Identifier:
First received: January 22, 2003
Last updated: October 20, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Anxiety Disorders
Social Phobia
Generalized Anxiety Disorder
Drug: Sertraline
Behavioral: Cognitive Behavioral Therapy (CBT)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Child/Adolescent Anxiety Multimodal Treatment Study

Resource links provided by NLM:

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Evidence of clinically significant improvement as rated by blind evaluator [ Time Frame: Measured at Week 12 ]

Secondary Outcome Measures:
  • Anxiety symptoms rated by self and parent [ Time Frame: Measured at Week 12 ]

Enrollment: 488
Study Start Date: January 2003
Estimated Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive sertraline for 12 weeks
Drug: Sertraline
Participants will take sertraline for 12 weeks.
Other Name: Zoloft
Experimental: 2
Participants will receive cognitive behavioral therapy for 12 weeks
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants will receive CBT for 12 weeks.
Experimental: 3
Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
Drug: Sertraline
Participants will take sertraline for 12 weeks.
Other Name: Zoloft
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants will receive CBT for 12 weeks.
Placebo Comparator: 4
Participants will receive placebo for 12 weeks
Drug: Placebo
Participants will take placebo capsules for 12 weeks.

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.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00052078

United States, California
Los Angeles, California, United States
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, New York
NYSPI/Columbia University
New York, New York, United States
United States, North Carolina
Duke University
Durham, North Carolina, United States
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh/WPIC
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: John T. Walkup, MD, Johns Hopkins University Identifier: NCT00052078     History of Changes
Other Study ID Numbers: U01MH064089 ( US NIH Grant/Contract Award Number )
Study First Received: January 22, 2003
Last Updated: October 20, 2008

Keywords provided by National Institute of Mental Health (NIMH):
Phobic Disorders
Anxiety, Separation

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Pathologic Processes
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs processed this record on April 24, 2017