Nctid:
NCT00000384
Payload:
{"FullStudy"=>{"Rank"=>474510, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000003193", "ConditionMeshTerm"=>"Compulsive Personality Disorder"}, {"ConditionMeshId"=>"D000009771", "ConditionMeshTerm"=>"Obsessive-Compulsive Disorder"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010554", "ConditionAncestorTerm"=>"Personality Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}, {"ConditionAncestorId"=>"D000001008", "ConditionAncestorTerm"=>"Anxiety Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6109", "ConditionBrowseLeafName"=>"Compulsive Personality Disorder", "ConditionBrowseLeafAsFound"=>"Compulsive Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12396", "ConditionBrowseLeafName"=>"Obsessive-Compulsive Disorder", "ConditionBrowseLeafAsFound"=>"Obsessive-Compulsive Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13152", "ConditionBrowseLeafName"=>"Personality Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4014", "ConditionBrowseLeafName"=>"Anxiety Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000020280", "InterventionMeshTerm"=>"Sertraline"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000928", "InterventionAncestorTerm"=>"Antidepressive Agents"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000017367", "InterventionAncestorTerm"=>"Selective Serotonin Reuptake Inhibitors"}, {"InterventionAncestorId"=>"D000014179", "InterventionAncestorTerm"=>"Neurotransmitter Uptake Inhibitors"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M21790", "InterventionBrowseLeafName"=>"Sertraline", "InterventionBrowseLeafAsFound"=>"30 min", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3937", "InterventionBrowseLeafName"=>"Antidepressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14164", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15202", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19339", "InterventionBrowseLeafName"=>"Selective Serotonin Reuptake Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20194", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2005", "CompletionDateStruct"=>{"CompletionDate"=>"April 2002"}, "LastUpdateSubmitDate"=>"August 19, 2016", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"August 22, 2016", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Adolescence", "Child", "Cognitive Therapy", "Combined Modality Therapy", "Obsessive-Compulsive Disorder", "Placebos", "Sertraline", "Patient Education", "Psychotherapy"]}, "ConditionList"=>{"Condition"=>["Obsessive-Compulsive Disorder"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"20855047", "ReferenceType"=>"derived", "ReferenceCitation"=>"Garcia AM, Sapyta JJ, Moore PS, Freeman JB, Franklin ME, March JS, Foa EB. Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1024-33; quiz 1086. doi: 10.1016/j.jaac.2010.06.013. Epub 2010 Sep 6."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.\n\nOne 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.\n\nThere 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.\n\nA child may be eligible for this study if he/she:\n\nHas obsessive-compulsive disorder (OCD) and is 8 - 16 years old.", "DetailedDescription"=>"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.\n\nOne 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.\n\nThe 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."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"16 years", "MinimumAge"=>"8 years", "StdAgeList"=>{"StdAge"=>["Child"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\n-\n\nPatients must have:\n\nDSM-IV diagnosed OCD."}, "IdentificationModule"=>{"NCTId"=>"NCT00000384", "BriefTitle"=>"Treatment of Obsessive-Compulsive Disorder (OCD) in Children", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Pennsylvania"}, "OfficialTitle"=>"Treatment of Pediatric Obsessive-Compulsive Disorder", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R01MH055126", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH055126", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01MH055126", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH055126", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R10MH055121", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R10MH055121", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"DSIR 84-CTM"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Cognitive Behavior Therapy", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"Educational Support", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"Sertraline", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"27710", "LocationCity"=>"Durham", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Duke Univ. Med. Ctr."}, {"LocationZip"=>"19104", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Pennsylvania"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Edna B. Foa, PhD", "OverallOfficialRole"=>"Principal Investigator"}, {"OverallOfficialName"=>"John S. March, MD, MPH", "OverallOfficialRole"=>"Principal Investigator"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of Pennsylvania", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Mental Health (NIMH)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
