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Child and Adolescent Anxiety Disorders (CAMS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00052078
First received: January 22, 2003
Last updated: August 21, 2017
Last verified: August 2017
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (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 Johns Hopkins University:

Primary Outcome Measures:
  • Clinical Global Impression - Improvement Scale [ Time Frame: 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.


Enrollment: 488
Study Start Date: January 2003
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sertraline
Participants received sertraline for 12 weeks.
Drug: Sertraline (SRT)
Participants were treated with sertraline.
Other Name: Zoloft
Active Comparator: CBT
Participants received cognitive behavioral therapy for 12 weeks
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants received CBT.
Active Comparator: SRT + CBT
Participants received both sertraline and CBT for 12 weeks.
Drug: Sertraline (SRT)
Participants were treated with sertraline.
Other Name: Zoloft
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants received CBT.
Placebo Comparator: Placebo
Participants received a placebo pill for 12 weeks.
Drug: Placebo
Participants were treated with a placebo pill.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  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 University
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
Johns Hopkins University
National Institute of Mental Health (NIMH)
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00052078     History of Changes
Other Study ID Numbers: U01MH064089 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
Study First Received: January 22, 2003
Results First Received: July 29, 2016
Last Updated: August 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Johns Hopkins University:
Phobic Disorders
Anxiety, Separation

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobic Disorders
Pathologic Processes
Mental Disorders
Sertraline
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

ClinicalTrials.gov processed this record on September 19, 2017