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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00000384 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder |
Behavioral: Cognitive Behavior Therapy Behavioral: Educational Support Drug: Sertraline |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Placebo Control |
| Official Title: | Treatment of Pediatric Obsessive-Compulsive Disorder |
| Study Start Date: | May 1997 |
| Estimated Study Completion Date: | April 2002 |
To contrast the degree and durability of improvement in pediatric obsessive-compulsive disorder (OCD), patients will be treated with 1 of 6 conditions (3 active treatments and 3 control treatments): sertraline alone (SER), OCD-specific Cognitive Behavior Therapy (CBT), both SER and CBT (SER plus CBT), pill placebo (PBO), pill PBO plus Educational Support (ES), and SER plus ES.
One in 200 youth suffers from OCD, yet relatively few receive appropriate treatment. Both CBT and medication appear beneficial in controlled studies; however, the relative efficacy of CBT and medication, alone and in combination (COMB) is unknown. Thus, well-designed treatment outcome studies are necessary to improve care for youth with OCD.
The experimental design covers 2 phases. Phase I is a 2 (site) x 2 (SER or pill PBO) x 3 (CBT, ES or non- psychosocial treatment) x 5 (repeated measures) factorial 12-week comparison of SER, CBT, COMB and the control conditions. In Phase II, responders advance to a 16-week discontinuation study to assess treatment durability. The primary outcome measure is the Yale-Brown Obsessive-Compulsive Scale. Assessments blind to treatment status take place at Week 0 (pretreatment); Weeks 1, 4, 8, 12 (Phase I treatment); and Weeks 16, 20, 24 and 28 (Phase II discontinuation). Besides addressing comparative efficacy and durability of the specified treatments, the investigators also examine time-action effects, differential effects on specific aspects of OCD, including functional impairment, and predictors of response to treatment.
Eligibility| Ages Eligible for Study: | 8 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Patients must have:
DSM-IV diagnosed OCD.
Contacts and Locations| United States, North Carolina | |
| Duke Univ. Med. Ctr. | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Edna B. Foa, PhD | |
| Principal Investigator: | John S. March, MD, MPH |
More Information
| Study ID Numbers: | R10 MH55126, R10 MH55121, DSIR 84-CTM |
| Study First Received: | November 2, 1999 |
| Last Updated: | November 18, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000384 History of Changes |
| Health Authority: | United States: Federal Government |
|
Adolescence Child Cognitive Therapy Combined Modality Therapy Obsessive-Compulsive Disorder |
Placebos Sertraline Patient Education Psychotherapy |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents |
Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Sertraline Central Nervous System Agents Obsessive-Compulsive Disorder Antidepressive Agents |
