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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 22, 2003
Last Updated Date	October 20, 2008
Start Date ^ICMJE	January 2003
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 12, 2008)	Evidence of clinically significant improvement as rated by blind evaluator [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00052078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 12, 2008)	Anxiety symptoms rated by self and parent [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Child and Adolescent Anxiety Disorders (CAMS)
Official Title ^ICMJE	Child/Adolescent Anxiety Multimodal Treatment Study
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Anxiety Disorders Social Phobia Generalized Anxiety Disorder
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	488
Estimated Completion Date	March 2008
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	7 Years to 17 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00052078
Other Study ID Numbers ^ICMJE	U01 MH64089, DSIR 84-CTP
Has Data Monitoring Committee	Not Provided
Responsible Party	John T. Walkup, MD, Johns Hopkins University
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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