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Treatment of Obsessive-Compulsive Disorder (OCD) in Children Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Treatment of Obsessive-Compulsive Disorder (OCD) in Children conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Treatment of Obsessive-Compulsive Disorder (OCD) in Children Clinical research trials and Treatment of Obsessive-Compulsive Disorder (OCD) in Children healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Treatment of Obsessive-Compulsive Disorder (OCD) in Children. Treatment of Obsessive-Compulsive Disorder (OCD) in Children Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Treatment of Obsessive-Compulsive Disorder (OCD) in Children clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Treatment of Obsessive-Compulsive Disorder (OCD) in Children condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Treatment of Obsessive-Compulsive Disorder (OCD) in Children  Treatment of Obsessive-Compulsive Disorder (OCD) in Children
Treatment of Obsessive-Compulsive Disorder (OCD) in Children
For Condition: Obsessive-Compulsive Disorder
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Placebo Control
Minimum Age/Maximum Age: 8 Years/16 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients must have: DSM-IV diagnosed OCD.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdnaFoa, Principal Investigator,
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Duke Univ. Med. Ctr.
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: MH55126; MH55121
Study Start Date: May 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000384
Other Obsessive-Compulsive Disorder Studies:
1. Treatment of Obsessive-Compulsive Disorder
2. Behavior Therapy for Children and Adolescents with Obsessive-Compulsive Disorder (OCD)
3. Treatment for Anxiety in Children
4. Treatment of Obsessive-Compulsive Disorder (OCD) in Children
5. Characterization of Childhood-Onset Obsessive-Compulsive Disorder
Related Studies:
Other Obsessive-Compulsive Disorder Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Treatment of Obsessive-Compulsive Disorder (OCD) in Children
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