Child and Adolescent Anxiety Disorders (CAMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00052078
First received: January 22, 2003
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety symptoms rated by self and parent [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052078

Locations
United States, California
UCLA
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
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John T. Walkup, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00052078     History of Changes
Other Study ID Numbers: U01 MH64089, DSIR 84-CTP
Study First Received: January 22, 2003
Last Updated: October 20, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014