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

January 22, 2003
October 20, 2008
January 2003
October 2007   (final data collection date for primary outcome measure)
Evidence of clinically significant improvement as rated by blind evaluator [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00052078 on ClinicalTrials.gov Archive Site
Anxiety symptoms rated by self and parent [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Child and Adolescent Anxiety Disorders (CAMS)
Child/Adolescent Anxiety Multimodal Treatment Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Social Phobia
  • Generalized Anxiety Disorder
  • Drug: Sertraline
    Participants will take sertraline for 12 weeks.
    Other Name: Zoloft
  • Behavioral: Cognitive Behavioral Therapy (CBT)
    Participants will receive CBT for 12 weeks.
  • Drug: Placebo
    Participants will take placebo capsules for 12 weeks.
  • Experimental: 1
    Participants will receive sertraline for 12 weeks
    Intervention: Drug: Sertraline
  • Experimental: 2
    Participants will receive cognitive behavioral therapy for 12 weeks
    Intervention: Behavioral: Cognitive Behavioral Therapy (CBT)
  • Experimental: 3
    Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
    Interventions:
    • Drug: Sertraline
    • Behavioral: Cognitive Behavioral Therapy (CBT)
  • Placebo Comparator: 4
    Participants will receive placebo for 12 weeks
    Intervention: Drug: Placebo
Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. Epub 2008 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
488
March 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
7 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00052078
U01 MH64089, DSIR 84-CTP
Not Provided
John T. Walkup, MD, Johns Hopkins University
National Institute of Mental Health (NIMH)
Not Provided
Not Provided
National Institute of Mental Health (NIMH)
October 2008

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