Child and Adolescent Anxiety Disorders (CAMS)

Johns Hopkins University

Status and phase: Completed; Phase 3

Conditions: Social Phobia; Generalized Anxiety Disorder; Anxiety Disorders

Treatments: Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Sertraline (SRT); Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00052078

DSIR 84-CTP

U01MH064089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 488 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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488 participants in 4 patient groups, including a placebo group

Sertraline

Active Comparator group

Description:

Participants received sertraline for 12 weeks.

Treatment:

Drug: Sertraline (SRT)

CBT

Active Comparator group

Description:

Participants received cognitive behavioral therapy for 12 weeks

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

SRT + CBT

Active Comparator group

Description:

Participants received both sertraline and CBT for 12 weeks.

Treatment:

Drug: Sertraline (SRT)

Behavioral: Cognitive Behavioral Therapy (CBT)

Placebo

Placebo Comparator group

Description:

Participants received a placebo pill for 12 weeks.

Treatment:

Drug: Placebo