Overview

This trial is active, not recruiting.

Conditions anxiety disorders, social phobia, generalized anxiety disorder
Treatments sertraline, cognitive behavioral therapy (cbt), placebo
Phase phase 3
Sponsor National Institute of Mental Health (NIMH)
Start date January 2003
End date October 2007
Trial size 488 participants
Trial identifier NCT00052078, DSIR 84-CTP, U01 MH64089

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive sertraline for 12 weeks
sertraline Zoloft
Participants will take sertraline for 12 weeks.
(Experimental)
Participants will receive cognitive behavioral therapy for 12 weeks
cognitive behavioral therapy (cbt)
Participants will receive CBT for 12 weeks.
(Experimental)
Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks
sertraline Zoloft
Participants will take sertraline for 12 weeks.
cognitive behavioral therapy (cbt)
Participants will receive CBT for 12 weeks.
(Placebo Comparator)
Participants will receive placebo for 12 weeks
placebo
Participants will take placebo capsules for 12 weeks.

Primary Outcomes

Measure
Evidence of clinically significant improvement as rated by blind evaluator
time frame: Measured at Week 12

Secondary Outcomes

Measure
Anxiety symptoms rated by self and parent
time frame: Measured at Week 12

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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

Additional Information

Official title Child/Adolescent Anxiety Multimodal Treatment Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH).