Nctid:
NCT00000385
Payload:
{"FullStudy"=>{"Rank"=>475223, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000000374", "ConditionMeshTerm"=>"Aggression"}, {"ConditionMeshId"=>"D000019955", "ConditionMeshTerm"=>"Conduct Disorder"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001526", "ConditionAncestorTerm"=>"Behavioral Symptoms"}, {"ConditionAncestorId"=>"D000019958", "ConditionAncestorTerm"=>"Attention Deficit and Disruptive Behavior Disorders"}, {"ConditionAncestorId"=>"D000065886", "ConditionAncestorTerm"=>"Neurodevelopmental Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3414", "ConditionBrowseLeafName"=>"Aggression", "ConditionBrowseLeafAsFound"=>"Aggression", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21517", "ConditionBrowseLeafName"=>"Conduct Disorder", "ConditionBrowseLeafAsFound"=>"Conduct Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4508", "ConditionBrowseLeafName"=>"Behavioral Symptoms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4284", "ConditionBrowseLeafName"=>"Attention Deficit Disorder with Hyperactivity", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21520", "ConditionBrowseLeafName"=>"Attention Deficit and Disruptive Behavior Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M30334", "ConditionBrowseLeafName"=>"Neurodevelopmental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14163", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4505", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000016651", "InterventionMeshTerm"=>"Lithium Carbonate"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000928", "InterventionAncestorTerm"=>"Antidepressive Agents"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018692", "InterventionAncestorTerm"=>"Antimanic Agents"}, {"InterventionAncestorId"=>"D000014149", "InterventionAncestorTerm"=>"Tranquilizing Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M18712", "InterventionBrowseLeafName"=>"Lithium Carbonate", "InterventionBrowseLeafAsFound"=>"Run-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3937", "InterventionBrowseLeafName"=>"Antidepressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14164", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Quadruple", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Care Provider", "Investigator", "Outcomes Assessor"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"59"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2013", "CompletionDateStruct"=>{"CompletionDate"=>"June 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"November 25, 2013", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 26, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"December 2003", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Overt Aggression Scale-Modified", "PrimaryOutcomeTimeFrame"=>"Weekly in short term phase, Monthly in long-term phase"}, {"PrimaryOutcomeMeasure"=>"Clinical Global Impressions-Improvement Item", "PrimaryOutcomeTimeFrame"=>"Weekly in short term phase, Monthly in long-term phase"}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Children's Psychiatric Rating Scale-Selected Items", "SecondaryOutcomeTimeFrame"=>"Weekly in short term phase, Monthly in long-term phase"}, {"SecondaryOutcomeMeasure"=>"IOWA", "SecondaryOutcomeTimeFrame"=>"Weekly in short term phase, Monthly in long-term phase"}, {"SecondaryOutcomeMeasure"=>"DOTES", "SecondaryOutcomeTimeFrame"=>"Weekly in short term phase, Monthly in long-term phase"}, {"SecondaryOutcomeMeasure"=>"TESS", "SecondaryOutcomeTimeFrame"=>"Weekly in short term phase, Monthly in long-term phase"}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Aggressive conduct disorder", "Adolescence", "Child", "Conduct Disorder", "Female", "Lithium", "Male", "Placebos", "Conduct Disorder -- *drug therapy", "Lithium -- *therapeutic use"]}, "ConditionList"=>{"Condition"=>["Conduct Disorder", "Aggression"]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).", "DetailedDescription"=>"Psychotherapeutic agents are often administered without sufficient testing to children and adolescents, often on a long-term basis, to reduce aggression. Many pressures, including managed care, will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems. Lithium is the most promising agent for the treatment of aggression in children and adolescents. However, it has not been shown that lithium is an effective treatment for these patients in the outpatient (non-hospital) setting, or on a long-term basis. The purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).\n\nThe proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder. Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design. Phase 1 contains a short-term 8-week controlled trial, with twice as many subjects randomized to lithium as placebo, increasing the pool of potential lithium responders to continue to Phase 2. In Phase 2, lithium responders from Phase 1 enter a 6-month long-term controlled trial. Every attempt is made to define responders to lithium."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"17 years", "MinimumAge"=>"9 years", "StdAgeList"=>{"StdAge"=>["Child"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nMales and females\nAges between 9 and 17 years.\nConduct disorder according to DSM-IV (As rated on the DICA-IV).\nThe aggression criterion at screening\n\nExclusion Criteria:\n\nMental Retardation.\nPervasive Developmental Disorder(s).\nMajor Depressive Disorder or Dysthymic Disorder.\nBipolar Disorder.\nPsychotic Disorder (including Schizophreniform Disorder and Schizophrenia).\nMajor medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder.\nHistory of psychoactive medication in the previous 2 weeks.\nCurrent Pregnancy in females.\nHistory of Substance Dependence in the past month.\nPrior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 mEq/L or higher for a cumulative period of greater than 10 days."}, "IdentificationModule"=>{"NCTId"=>"NCT00000385", "BriefTitle"=>"Long-Term Lithium Treatment for Aggressive Conduct Disorder", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Drexel University"}, "OfficialTitle"=>"Long-Term Lithium for Aggressive Conduct Disorder", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R29MH057093", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R29MH057093", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R29MH057093", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R29MH057093", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"DSIR CT-M"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Lithium 600 mg to 2700 mg per day", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Lithium"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"2", "ArmGroupDescription"=>"Matching placebo", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Placebo"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Lithium", "InterventionType"=>"Drug", "InterventionDescription"=>"Lithium 600 mg to 2700 mg per day", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1"]}}, {"InterventionName"=>"Placebo", "InterventionType"=>"Drug", "InterventionDescription"=>"Matching placebo", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["2"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"19124", "LocationCity"=>"Philadelphia", "LocationState"=>"Pennsylvania", "LocationCountry"=>"United States", "LocationFacility"=>"Drexel University College of Medicine at Friends Hospital"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Richard P. Malone, MD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Drexel University College of Medicine"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Drexel University", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Mental Health (NIMH)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyOldNameTitle"=>"Richard P. Malone, MD", "ResponsiblePartyOldOrganization"=>"Drexel University College of Medicine"}}}}}}
