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
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
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Child/Adolescent Anxiety Multimodal Treatment Study |
Resource links provided by NLM:
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 |
|---|---|
|
Experimental: 1
Participants will receive sertraline for 12 weeks
|
Drug: Sertraline
Participants will take sertraline for 12 weeks.
Other Name: Zoloft
|
|
Experimental: 2
Participants will receive cognitive behavioral therapy for 12 weeks
|
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants will receive CBT for 12 weeks.
|
|
Experimental: 3
Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
|
Drug: Sertraline
Participants will take sertraline for 12 weeks.
Other Name: Zoloft
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants will receive CBT for 12 weeks.
|
|
Placebo Comparator: 4
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
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | John T. Walkup, MD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00052078 History of Changes |
| Other Study ID Numbers: | U01 MH64089, DSIR 84-CTP |
| Study First Received: | January 22, 2003 |
| Last Updated: | October 20, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Phobic Disorders Anxiety, Separation |
Additional relevant MeSH terms:
|
Anxiety Disorders Phobic Disorders Mental Disorders Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013