Nctid:
NCT00000389
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001008", "term"=>"Anxiety Disorders"}, {"id"=>"D000009771", "term"=>"Obsessive-Compulsive Disorder"}, {"id"=>"D000072861", "term"=>"Phobia, Social"}, {"id"=>"D000001010", "term"=>"Anxiety, Separation"}], "ancestors"=>[{"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000010698", "term"=>"Phobic Disorders"}, {"id"=>"D000065886", "term"=>"Neurodevelopmental Disorders"}], "browseLeaves"=>[{"id"=>"M4324", "name"=>"Anxiety Disorders", "asFound"=>"Anxiety Disorder", "relevance"=>"HIGH"}, {"id"=>"M6419", "name"=>"Compulsive Personality Disorder", "relevance"=>"LOW"}, {"id"=>"M12706", "name"=>"Obsessive-Compulsive Disorder", "asFound"=>"Obsessive-Compulsive Disorder", "relevance"=>"HIGH"}, {"id"=>"M1117", "name"=>"Phobia, Social", "asFound"=>"Social Phobia", "relevance"=>"HIGH"}, {"id"=>"M13603", "name"=>"Phobic Disorders", "relevance"=>"LOW"}, {"id"=>"M4326", "name"=>"Anxiety, Separation", "asFound"=>"Separation Anxiety", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000016666", "term"=>"Fluvoxamine"}], "ancestors"=>[{"id"=>"D000014151", "term"=>"Anti-Anxiety Agents"}, {"id"=>"D000014149", "term"=>"Tranquilizing Agents"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000017367", "term"=>"Selective Serotonin Reuptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000018490", "term"=>"Serotonin Agents"}, {"id"=>"D000018687", "term"=>"Antidepressive Agents, Second-Generation"}, {"id"=>"D000000928", "term"=>"Antidepressive Agents"}, {"id"=>"D000065609", "term"=>"Cytochrome P-450 CYP1A2 Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}], "browseLeaves"=>[{"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M19035", "name"=>"Fluvoxamine", "asFound"=>"Lopinavir/Ritonavir", "relevance"=>"HIGH"}, {"id"=>"M16905", "name"=>"Anti-Anxiety Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M19649", "name"=>"Selective Serotonin Reuptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2005-11", "completionDateStruct"=>{"date"=>"1999-11"}, "lastUpdateSubmitDate"=>"2007-06-13", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2007-06-14", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Adolescence", "Anxiety Disorders", "Child", "Female", "Fluvoxamine", "Human", "Male", "Serotonin Uptake Inhibitors", "Anxiety Disorders -- *drug therapy", "Fluvoxamine -- *therapeutic use", "Serotonin Uptake Inhibitors -- *therapeutic use"], "conditions"=>["Obsessive-Compulsive Disorder", "Anxiety Disorders", "Generalized Anxiety Disorder", "Social Phobia", "Separation Anxiety"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11323729", "type"=>"BACKGROUND", "citation"=>"Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85. doi: 10.1056/NEJM200104263441703."}, {"pmid"=>"11320394", "type"=>"BACKGROUND", "citation"=>"Coyle JT. Drug treatment of anxiety disorders in children. N Engl J Med. 2001 Apr 26;344(17):1326-7. doi: 10.1056/NEJM200104263441711. No abstract available."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is effective to treat children with anxiety disorders with fluvoxamine.\n\nFluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social phobia, or separation anxiety, are very common in youth and are not always responsive to behavioral therapies alone. These disorders may respond to fluvoxamine.\n\nA child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this double-blind phase (neither the child/parents nor the doctor know which treatment is being given), the child will have the option of continuing treatment during a 4-month open-label extension period (both the child/parents and the doctor know which the child is receiving).\n\nA child may be eligible for this study if he/she:\n\nIs 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, social phobia, or separation anxiety).", "detailedDescription"=>"To evaluate fluvoxamine in the treatment of children and adolescents with anxiety disorders.\n\nFluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD are very common in youth and are not always responsive to psychosocial therapies. Fluvoxamine is an alternative treatment.\n\nAfter a 3-week period of evaluation, patients meeting study entry criteria are randomized to receive either fluvoxamine or placebo for 8 weeks. After this double-blind phase, patients can enter a 4-month open-label extension."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety."}, "identificationModule"=>{"nctId"=>"NCT00000389", "briefTitle"=>"Treatment for Anxiety in Children", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Mental Health (NIMH)"}, "officialTitle"=>"Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study", "orgStudyIdInfo"=>{"id"=>"N01 MH60005"}, "secondaryIdInfos"=>[{"id"=>"N01 MH60016"}, {"id"=>"DSIR CT"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Fluvoxamine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Laurence Greenhill, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Mark Riddle, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}}}}
