Nctid:
NCT00000373
Payload:
{"FullStudy"=>{"Rank"=>498953, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "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"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6419", "ConditionBrowseLeafName"=>"Compulsive Personality Disorder", "ConditionBrowseLeafAsFound"=>"Compulsive Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12706", "ConditionBrowseLeafName"=>"Obsessive-Compulsive Disorder", "ConditionBrowseLeafAsFound"=>"Obsessive-Compulsive Disorder", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M8991", "ConditionBrowseLeafName"=>"Tourette Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13462", "ConditionBrowseLeafName"=>"Personality Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4324", "ConditionBrowseLeafName"=>"Anxiety Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Diseases and Abnormalities at or Before Birth", "ConditionBrowseBranchAbbrev"=>"BC16"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000077152", "InterventionMeshTerm"=>"Olanzapine"}, {"InterventionMeshId"=>"D000005473", "InterventionMeshTerm"=>"Fluoxetine"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000932", "InterventionAncestorTerm"=>"Antiemetics"}, {"InterventionAncestorId"=>"D000001337", "InterventionAncestorTerm"=>"Autonomic Agents"}, {"InterventionAncestorId"=>"D000018373", "InterventionAncestorTerm"=>"Peripheral Nervous System Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000005765", "InterventionAncestorTerm"=>"Gastrointestinal Agents"}, {"InterventionAncestorId"=>"D000014150", "InterventionAncestorTerm"=>"Antipsychotic Agents"}, {"InterventionAncestorId"=>"D000014149", "InterventionAncestorTerm"=>"Tranquilizing Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"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"=>"D000018687", "InterventionAncestorTerm"=>"Antidepressive Agents, Second-Generation"}, {"InterventionAncestorId"=>"D000000928", "InterventionAncestorTerm"=>"Antidepressive Agents"}, {"InterventionAncestorId"=>"D000065690", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2D6 Inhibitors"}, {"InterventionAncestorId"=>"D000065607", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M7473", "InterventionBrowseLeafName"=>"Dopamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15512", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16904", "InterventionBrowseLeafName"=>"Antipsychotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9312", "InterventionBrowseLeafName"=>"Haloperidol", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M215475", "InterventionBrowseLeafName"=>"Haloperidol decanoate", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8601", "InterventionBrowseLeafName"=>"Fluoxetine", "InterventionBrowseLeafAsFound"=>"Results of", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17115", "InterventionBrowseLeafName"=>"Tryptophan", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M1675", "InterventionBrowseLeafName"=>"Olanzapine", "InterventionBrowseLeafAsFound"=>"Cavity", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19035", "InterventionBrowseLeafName"=>"Fluvoxamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20596", "InterventionBrowseLeafName"=>"Dopamine Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4251", "InterventionBrowseLeafName"=>"Antiemetics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M8881", "InterventionBrowseLeafName"=>"Gastrointestinal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14474", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19649", "InterventionBrowseLeafName"=>"Selective Serotonin Reuptake Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4247", "InterventionBrowseLeafName"=>"Antidepressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30537", "InterventionBrowseLeafName"=>"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T21", "InterventionBrowseLeafName"=>"Tryptophan", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Cardiotonic Agents", "InterventionBrowseBranchAbbrev"=>"CaAg"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"Anti-Dyskinesia Agents", "InterventionBrowseBranchAbbrev"=>"AnDyAg"}, {"InterventionBrowseBranchName"=>"Antiemetics", "InterventionBrowseBranchAbbrev"=>"AnEm"}, {"InterventionBrowseBranchName"=>"Gastrointestinal Agents", "InterventionBrowseBranchAbbrev"=>"Gast"}, {"InterventionBrowseBranchName"=>"Amino Acids", "InterventionBrowseBranchAbbrev"=>"AA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Single", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"74"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1992"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2013", "CompletionDateStruct"=>{"CompletionDate"=>"July 2003", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"November 26, 2013", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"November 2, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 27, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 3, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"January 2003", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"25% reduction in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline", "PrimaryOutcomeTimeFrame"=>"Baseline, Week s 1, 2, 4, 6, 8, 10, 12, and 14"}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Adolescence", "Adult", "Antipsychotic Agents", "Dopamine Antagonists", "Female", "Fluvoxamine", "Haloperidol", "Human", "Male", "Middle Age", "Obsessive-Compulsive Disorder", "Placebos", "Serotonin Uptake Inhibitors", "Tourette Syndrome", "Tryptophan", "Drug Combinations", "Antipsychotic Agents -- *therapeutic use", "Fluvoxamine -- *therapeutic use", "Haloperidol -- *therapeutic use", "Obsessive-Compulsive Disorder -- *drug therapy", "Obsessive-Compulsive Disorder -- physiopathology", "Serotonin Uptake Inhibitors -- *therapeutic use"]}, "ConditionList"=>{"Condition"=>["Obsessive-Compulsive Disorder"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"15023585", "ReferenceType"=>"background", "ReferenceCitation"=>"Shapira NA, Ward HE, Mandoki M, Murphy TK, Yang MC, Blier P, Goodman WK. A double-blind, placebo-controlled trial of olanzapine addition in fluoxetine-refractory obsessive-compulsive disorder. Biol Psychiatry. 2004 Mar 1;55(5):553-5. doi: 10.1016/j.biopsych.2003.11.010."}, {"ReferencePMID"=>"20579510", "ReferenceType"=>"derived", "ReferenceCitation"=>"Koran LM, Bromberg D, Hornfeldt CS, Shepski JC, Wang S, Hollander E. Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder. Compr Psychiatry. 2010 Jul-Aug;51(4):373-9. doi: 10.1016/j.comppsych.2009.10.001. Epub 2009 Dec 21."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics).\n\nThere are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.", "DetailedDescription"=>"To advance the neurobiology and treatment of obsessive-compulsive disorder (OCD) by focusing on Tourette's Syndrome (TS)-spectrum OCD as a possible homogeneous form of OCD, and investigating the relevance of intact 5-hydroxytryptamine (5-HT) function to the mechanism of anti-OC drug action. The validity of TS-spectrum OCD as a distinct subtype is assessed using a detailed clinical, family, drug treatment response profile in adult OCD patients.\n\nIn Study I, patients are divided prospectively into 2 putative subtypes (TS-spectrum and non-TS-spectrum OCD) on the basis of clinical history and direct, structured interviews of family members (approximately 400 interviews).\n\nIn Study II, patients enter an 8-week single-blind trial with the potent and selective 5-HT reuptake inhibitor fluoxetine (FX). Patients with an incomplete response to FX alone (approximately 64 patients) are randomized to a 4-week double-blind trial of FX in combination with the dopamine (DA) 2 antagonist olanzapine (OLA) or placebo (PLA)."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"70 years", "MinimumAge"=>"14 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion criteria required that subjects, ages 14-70 years, have at least a 1-year duration of a current Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) principal diagnosis of OCD. Furthermore, the OCD had to be defined by a rating of \"moderate\" or greater on the global severity item of the Clinical Global Impressions (CGI) scale and have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 19 or greater.\n\nExclusion criteria included primary depression, schizophrenia, or other psychotic disorders; active bipolar disorder; abuse of alcohol or other significant substance within 6 months; increased risk of seizures or history of neurosurgery, encephalitis, or significant head trauma; or a significant medical condition, such as heart, liver, or renal disease. Subjects with an intelligence quotient of less than 80 as determined with the Kaufman Brief Intelligence Test (Kaufman and Kaufman 1990) were excluded."}, "IdentificationModule"=>{"NCTId"=>"NCT00000373", "BriefTitle"=>"Treatment of Obsessive-Compulsive Disorder", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of Florida"}, "OfficialTitle"=>"Neurobiology/Treatment of Obsessive-Compulsive Disorder", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R01MH045802", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH045802", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01MH045802", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01MH045802", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"olanzapine + fluoxetine", "ArmGroupDescription"=>"The specific aim was to determine whether combined treatment with fluoxetine plus olanzapine would be more effective than fluoxetine plus placebo in treating OCD subjects who were partial or nonresponders to a prospective, 8-week, open-label trial of fluoxetine.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: placebo + fluoxetine"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"placebo + fluoxetine", "ArmGroupDescription"=>"The specific aim was to determine whether combined treatment with fluoxetine plus olanzapine would be more effective than fluoxetine plus placebo in treating OCD subjects who were partial or nonresponders to a prospective, 8-week, open-label trial of fluoxetine.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: olanzapine + fluoxetine"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"olanzapine + fluoxetine", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["placebo + fluoxetine"]}}, {"InterventionName"=>"placebo + fluoxetine", "InterventionType"=>"Drug", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["olanzapine + fluoxetine"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"32608", "LocationCity"=>"Gainesville", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"Psychiatric Specialty Clinic, Shands Hospital at the University of Florida"}, {"LocationZip"=>"32257", "LocationCity"=>"Jacksonville", "LocationState"=>"Florida", "LocationCountry"=>"United States", "LocationFacility"=>"University of Florida Behavioral Health Mandarin Clinic"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Wayne Goodman, MD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of Florida"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of Florida", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Mental Health (NIMH)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
