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Completed

NCT Number: NCT00052078

Child and Adolescent Anxiety Disorders (CAMS)

This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

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Key information

Conditions

Anxiety Disorders Anxiety, Separation Generalized Anxiety Disorder Mental Disorders Neurodevelopmental Disorders Phobia, Social Phobic Disorders Social Phobia

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCLA, Los Angeles, California, United States

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About this study

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. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo.

During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnostic and Statistical Manual of Mental Disorders (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

Treatment and study plan

Sertraline (SRT)

Drug

Participants were treated with sertraline.

Other names: Zoloft

Cognitive Behavioral Therapy (CBT)

Behavioral

Participants received CBT.

Placebo

Drug

Participants were treated with a placebo pill.

Primary outcomes

  1. Clinical Global Impression - Improvement Scale

    Time frame: Measured at Week 12

    The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Child/Adolescent Anxiety Multimodal Treatment Study

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Jan 23, 2003
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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