Child and Adolescent Anxiety Disorders (CAMS) - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00052078

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Child/Adolescent Anxiety Multimodal Treatment Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Phobias

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Evidence of clinically significant improvement as rated by blind evaluator [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anxiety symptoms rated by self and parent [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Enrollment:	488
Study Start Date:	January 2003
Estimated Study Completion Date:	March 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive sertraline for 12 weeks	Drug: Sertraline Participants will take sertraline for 12 weeks.
2: Experimental Participants will receive cognitive behavioral therapy for 12 weeks	Behavioral: Cognitive Behavioral Therapy (CBT) Participants will receive CBT for 12 weeks.
3: Experimental Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks	Drug: Sertraline Participants will take sertraline for 12 weeks. Behavioral: Cognitive Behavioral Therapy (CBT) Participants will receive CBT for 12 weeks.
4: Placebo Comparator Participants will receive placebo for 12 weeks	Drug: Placebo Participants will take placebo capsules for 12 weeks.

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.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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
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

National Institute of Mental Health (NIMH)

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Johns Hopkins University ( John T. Walkup, MD )
Study ID Numbers:	U01 MH64089, DSIR 84-CTP
Study First Received:	January 22, 2003
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00052078 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Phobic Disorders
Anxiety, Separation

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Phobic Disorders
Serotonin Uptake Inhibitors
Pharmacologic Actions

Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009