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Child and Adolescent Anxiety Disorders (CAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00052078
Recruitment Status : Completed
First Posted : January 23, 2003
Results First Posted : April 25, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052078


Locations
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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
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Publications of Results:

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

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00052078    
Other Study ID Numbers: U01MH064089 ( U.S. NIH Grant/Contract )
U01MH064089 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
First Posted: January 23, 2003    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: September 19, 2017
Last Verified: August 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:
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Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic 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