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Treatment of Obsessive-Compulsive Disorder (OCD) in Children

NCT00000384 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-08-22

No results posted yet for this study

Summary

The purpose of this study is to compare 3 treatments for children with OCD: medication (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs medication plus therapy. Some patients will receive an inactive placebo (PBO) instead of medication and/or Educational Support (ES, non-psychological treatment) instead of therapy.

One in 200 children suffer from OCD, but few receive appropriate treatment. Both CBT and medication seem to be effective, but their effectiveness, alone and in combination, has not been evaluated.

There are 2 phases to this trial. In Phase I the child will receive 1 of the following 6 treatments for 12 weeks: 1) SER alone; 2) pill PBO alone; 3) CBT alone; 4) SER plus CBT; 5) SER plus ES; 6) pill PBO plus ES. If the child responds to treatment, he/she will go on to Phase II in which the treatment will be slowly reduced, then stopped (discontinued), over time to test the treatment's durability. The child will be evaluated at Weeks 1, 4, 8, 12 (Phase I treatment), and Weeks 16, 20, 24, and 28 (Phase II discontinuation) to see how effective and durable the treatment is in treating your child's OCD.

A child may be eligible for this study if he/she:

Has obsessive-compulsive disorder (OCD) and is 8 - 16 years old.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

BEHAVIORAL

Cognitive Behavior Therapy

BEHAVIORAL

Educational Support

DRUG

Sertraline

Sponsors & Collaborators

Principal Investigators

  • Edna B. Foa, PhD

  • John S. March, MD, MPH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
8 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Completion
2002-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000384 on ClinicalTrials.gov