Nctid:
NCT00000374
Payload:
{"FullStudy"=>{"Rank"=>498952, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012559", "ConditionMeshTerm"=>"Schizophrenia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019967", "ConditionAncestorTerm"=>"Schizophrenia Spectrum and Other Psychotic Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M15376", "ConditionBrowseLeafName"=>"Schizophrenia", "ConditionBrowseLeafAsFound"=>"Schizophrenia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M21838", "ConditionBrowseLeafName"=>"Schizophrenia Spectrum and Other Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000077152", "InterventionMeshTerm"=>"Olanzapine"}, {"InterventionMeshId"=>"D000018967", "InterventionMeshTerm"=>"Risperidone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000012702", "InterventionAncestorTerm"=>"Serotonin Antagonists"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000014150", "InterventionAncestorTerm"=>"Antipsychotic Agents"}, {"InterventionAncestorId"=>"D000014149", "InterventionAncestorTerm"=>"Tranquilizing Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000018492", "InterventionAncestorTerm"=>"Dopamine Antagonists"}, {"InterventionAncestorId"=>"D000015259", "InterventionAncestorTerm"=>"Dopamine Agents"}, {"InterventionAncestorId"=>"D000000932", "InterventionAncestorTerm"=>"Antiemetics"}, {"InterventionAncestorId"=>"D000001337", "InterventionAncestorTerm"=>"Autonomic Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000005765", "InterventionAncestorTerm"=>"Gastrointestinal Agents"}, {"InterventionAncestorId"=>"D000017367", "InterventionAncestorTerm"=>"Selective Serotonin Reuptake Inhibitors"}, {"InterventionAncestorId"=>"D000014179", "InterventionAncestorTerm"=>"Neurotransmitter Uptake Inhibitors"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M16904", "InterventionBrowseLeafName"=>"Antipsychotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20999", "InterventionBrowseLeafName"=>"Risperidone", "InterventionBrowseLeafAsFound"=>"Added", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1675", "InterventionBrowseLeafName"=>"Olanzapine", "InterventionBrowseLeafAsFound"=>"Cavity", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M15512", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14474", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7473", "InterventionBrowseLeafName"=>"Dopamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20596", "InterventionBrowseLeafName"=>"Dopamine Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17962", "InterventionBrowseLeafName"=>"Dopamine Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4251", "InterventionBrowseLeafName"=>"Antiemetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8881", "InterventionBrowseLeafName"=>"Gastrointestinal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19649", "InterventionBrowseLeafName"=>"Selective Serotonin Reuptake Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antiemetics", "InterventionBrowseBranchAbbrev"=>"AnEm"}, {"InterventionBrowseBranchName"=>"Gastrointestinal Agents", "InterventionBrowseBranchAbbrev"=>"Gast"}, {"InterventionBrowseBranchName"=>"Cardiotonic Agents", "InterventionBrowseBranchAbbrev"=>"CaAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Single", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Outcomes Assessor"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"125"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1998"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2012", "CompletionDateStruct"=>{"CompletionDate"=>"May 2007", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"January 12, 2012", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 13, 2012", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"May 2007", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Treatment response", "PrimaryOutcomeTimeFrame"=>"8 consecutive weeks"}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Adolescence", "Adult", "Antipsychotic Agents", "Female", "Human", "Male", "olanzapine", "Risperidone", "Schizophrenia", "Antipsychotic Agents -- *therapeutic use", "olanzapine -- *therapeutic use", "Risperidone -- *therapeutic use", "Schizophrenia -- *drug therapy"]}, "ConditionList"=>{"Condition"=>["Schizophrenia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"21939612", "ReferenceType"=>"derived", "ReferenceCitation"=>"Gallego JA, Robinson DG, Sevy SM, Napolitano B, McCormack J, Lesser ML, Kane JM. Time to treatment response in first-episode schizophrenia: should acute treatment trials last several months? J Clin Psychiatry. 2011 Dec;72(12):1691-6. doi: 10.4088/JCP.10m06349. Epub 2011 Sep 6."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.", "DetailedDescription"=>"The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs: olanzapine, risperidone.\n\nLong-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications. However, in the years immediately following this initial good response, morbidity increases. Relapses, often multiple ones, are the rule and are usually precipitated by medication noncompliance. There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains. However, these newer agents have been studied primarily in chronic and/or treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another.\n\nFirst episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years. Outcome measures for the initial episode include psychopathology (positive, negative, and affective symptoms), side effects, neurocognition (executive function, memory, and attention), social and occupational function and service utilization. The effects on long-term course are measured in terms of frequency and timing of relapses, level of recovery from subsequent episodes and prospectively assessed course of psychopathology, neurocognitive function, social/vocational function, and service utilization.\n\nFor information on a related study, please follow this link:\n\nhttp://clinicaltrials.gov/show/NCT00320671"}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"40 years", "MinimumAge"=>"16 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nFirst episode schizophrenia, schizophreniform disorder or schizoaffective disorder\n\nExclusion Criteria:\n\nPrior treatment with antipsychotic medications."}, "IdentificationModule"=>{"NCTId"=>"NCT00000374", "BriefTitle"=>"Treatment for First-Episode Schizophrenia", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Northwell Health"}, "OfficialTitle"=>"Preventing Morbidity in First-Episode Schizophrenia", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R01MH060004-01", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH060004-01", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01MH060004-01", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH060004-01", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"DSIR 83-ATAP"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Olanzapine", "InterventionType"=>"Drug", "InterventionDescription"=>"The dosage for Olanzapine will be 2.5 mg to 20mg per day. The dose of the Olanzapine will be based on the participant's clinical improvement and side effects."}, {"InterventionName"=>"Risperidone", "InterventionType"=>"Drug", "InterventionDescription"=>"The dosage for Risperidone will be 1 mg to 6mg per day. The dose of the Risperidone will be based on the participant's clinical improvement and side effects."}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"10456", "LocationCity"=>"Bronx", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Bronx-Lebanon Hospital Center"}, {"LocationZip"=>"11004", "LocationCity"=>"Glen Oaks", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Hillside Hospital"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Delbert Robinson, MD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"The Zucker Hillside Hospital"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Northwell Health", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Mental Health (NIMH)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"The Zucker Hillside Hospital", "CollaboratorClass"=>"OTHER"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Delbert Robinson, MD/Prinicipal Investigator", "ResponsiblePartyInvestigatorFullName"=>"Delbert Robinson", "ResponsiblePartyInvestigatorAffiliation"=>"National Institute of Mental Health (NIMH)"}}}}}}
