Child and Adolescent Anxiety Disorders (CAMS)

Phase 3CompletedNCT00052078

Johns Hopkins University488 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

488

Conditions

Anxiety Disorders Social Phobia Generalized Anxiety Disorder

Interventions

Sertraline (SRT)DRUG

Participants were treated with sertraline.

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

Participants received CBT.

PlaceboDRUG

Participants were treated with a placebo pill.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

UCLA

Los Angeles, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

NYSPI/Columbia University

New York, New York, United States

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Clinical Global Impression - Improvement Scale

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.

Time frame: Measured at Week 12

Data from ClinicalTrials.gov

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