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Child and Adolescent Anxiety Disorders (CAMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052078
First Posted: January 23, 2003
Last Update Posted: September 19, 2017
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins University
January 22, 2003
January 23, 2003
July 29, 2016
April 25, 2017
September 19, 2017
January 2003
October 2007   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00052078 on ClinicalTrials.gov Archive Site
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Child and Adolescent Anxiety Disorders (CAMS)
Child/Adolescent Anxiety Multimodal Treatment Study
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Social Phobia
  • Generalized Anxiety Disorder
  • Drug: Sertraline (SRT)
    Participants were treated with sertraline.
    Other Name: Zoloft
  • Behavioral: Cognitive Behavioral Therapy (CBT)
    Participants received CBT.
  • Drug: Placebo
    Participants were treated with a placebo pill.
  • Active Comparator: Sertraline
    Participants received sertraline for 12 weeks.
    Intervention: Drug: Sertraline (SRT)
  • Active Comparator: CBT
    Participants received cognitive behavioral therapy for 12 weeks
    Intervention: Behavioral: Cognitive Behavioral Therapy (CBT)
  • Active Comparator: SRT + CBT
    Participants received both sertraline and CBT for 12 weeks.
    Interventions:
    • Drug: Sertraline (SRT)
    • Behavioral: Cognitive Behavioral Therapy (CBT)
  • Placebo Comparator: Placebo
    Participants received a placebo pill for 12 weeks.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
March 2008
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00052078
U01MH064089( U.S. NIH Grant/Contract )
U01MH064089 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
Not Provided
Not Provided
Plan to Share IPD: Yes
Johns Hopkins University
Johns Hopkins University
National Institute of Mental Health (NIMH)
Not Provided
Johns Hopkins University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP