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Trial NCT00000384

Resource URI: http://static.linkedct.org/resource/trials/NCT00000384
linkedct:brief_title Treatment of Obsessive-Compulsive Disorder (OCD) in Children
linkedct:condition <http://static.linkedct.org/resource/condition/9124>
linkedct:criteria Inclusion Criteria: - Patients must have: DSM-IV diagnosed OCD.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 16 Years
linkedct:eligibility_minimum_age 8 Years
linkedct:end_date April 2002
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000384
rdfs:label Trial NCT00000384
linkedct:lastchanged_date November 18, 2005
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/160157>
linkedct:location <http://static.linkedct.org/resource/location/167095>
linkedct:nct_id NCT00000384
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Treatment of Pediatric Obsessive-Compulsive Disorder
linkedct:org_study_id R10 MH55126
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15356>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/29409>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000384>
linkedct:phase Phase 3
linkedct:secondary_id DSIR 84-CTM
linkedct:secondary_id R10 MH55121
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date May 1997
linkedct:study_design Treatment, Placebo Control
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2005