Nctid:
NCT06223880
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012008", "term"=>"Recurrence"}, {"id"=>"D003866", "term"=>"Depressive Disorder"}, {"id"=>"D003863", "term"=>"Depression"}, {"id"=>"D003865", "term"=>"Depressive Disorder, Major"}], "ancestors"=>[{"id"=>"D019964", "term"=>"Mood Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}, {"id"=>"D001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depressive Symptoms", "relevance"=>"HIGH"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "asFound"=>"Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M7060", "name"=>"Depressive Disorder, Major", "asFound"=>"Major Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Relapse", "relevance"=>"HIGH"}, {"id"=>"M21835", "name"=>"Mood Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D016642", "term"=>"Bupropion"}], "ancestors"=>[{"id"=>"D018687", "term"=>"Antidepressive Agents, Second-Generation"}, {"id"=>"D000928", "term"=>"Antidepressive Agents"}, {"id"=>"D011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D018765", "term"=>"Dopamine Uptake Inhibitors"}, {"id"=>"D014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D015259", "term"=>"Dopamine Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D065690", "term"=>"Cytochrome P-450 CYP2D6 Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M351583", "name"=>"Levomethorphan", "relevance"=>"LOW"}, {"id"=>"M7110", "name"=>"Dextromethorphan", "relevance"=>"LOW"}, {"id"=>"M19013", "name"=>"Bupropion", "asFound"=>"Dynamic", "relevance"=>"HIGH"}, {"id"=>"M6263", "name"=>"Coal Tar", "relevance"=>"LOW"}, {"id"=>"M12575", "name"=>"Norepinephrine", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M20832", "name"=>"Dopamine Uptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antitussive Agents", "abbrev"=>"AnTuAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>350}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-27", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2026-03", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-09", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-03", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Time from randomization to relapse of depressive symptoms", "timeFrame"=>"up to 26 weeks"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["AXS-05", "Dextromethorphan", "Bupropion", "MDD", "Depression", "Relapse of depressive symptoms", "NMDA receptor antagonist", "Sigma-1 receptor agonist", "Norepinephrine reuptake inhibitor", "Dopamine reuptake inhibitor", "Axsome Therapeutics"], "conditions"=>["Major Depressive Disorder"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://www.axsome.com", "label"=>"Axsome Therapeutics Website"}]}, "descriptionModule"=>{"briefSummary"=>"This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.", "detailedDescription"=>"Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features\n* Current major depressive episode of at least 4 weeks in duration\n\nExclusion Criteria:\n\n* Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.\n* Unable to comply with study procedures\n* Medically inappropriate for study participation in the opinion of the investigator"}, "identificationModule"=>{"nctId"=>"NCT06223880", "briefTitle"=>"A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Axsome Therapeutics, Inc."}, "officialTitle"=>"A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms", "orgStudyIdInfo"=>{"id"=>"AXS-05-MDD-401"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"AXS-05", "description"=>"AXS-05 tablets, taken twice daily", "interventionNames"=>["Drug: AXS-05"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Bupropion", "description"=>"Bupropion tablets, taken twice daily", "interventionNames"=>["Drug: Bupropion"]}], "interventions"=>[{"name"=>"AXS-05", "type"=>"DRUG", "description"=>"Up to 10 weeks in open-label period;\n\nUp to 26 weeks in double-blind period", "armGroupLabels"=>["AXS-05"]}, {"name"=>"Bupropion", "type"=>"DRUG", "description"=>"Up to 26 weeks in double-blind period", "armGroupLabels"=>["Bupropion"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90706", "city"=>"Bellflower", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>33.88168, "lon"=>-118.11701}}, {"zip"=>"94549", "city"=>"Lafayette", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>37.88576, "lon"=>-122.11802}}, {"zip"=>"92056", "city"=>"Oceanside", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>33.19587, "lon"=>-117.37948}}, {"zip"=>"92374", "city"=>"Redlands", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>34.05557, "lon"=>-117.18254}}, {"zip"=>"92506", "city"=>"Riverside", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>33.95335, "lon"=>-117.39616}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"91786", "city"=>"Upland", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>34.09751, "lon"=>-117.64839}}, {"zip"=>"33511", "city"=>"Brandon", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>27.9378, "lon"=>-82.28592}}, {"zip"=>"33122", "city"=>"Doral", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>25.81954, "lon"=>-80.35533}}, {"zip"=>"33012", "city"=>"Hialeah", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>25.8576, "lon"=>-80.27811}}, {"zip"=>"32256", "city"=>"Jacksonville", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33122", "city"=>"Miami", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"32801", "city"=>"Orlando", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>28.53834, "lon"=>-81.37924}}, {"zip"=>"32806", "city"=>"Orlando", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>28.53834, "lon"=>-81.37924}}, {"zip"=>"32807", "city"=>"Orlando", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>28.53834, "lon"=>-81.37924}}, {"zip"=>"30331", "city"=>"Atlanta", "state"=>"Georgia", 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"state"=>"Missouri", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>38.78394, "lon"=>-90.48123}}, {"zip"=>"89102", "city"=>"Las Vegas", "state"=>"Nevada", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>36.17497, "lon"=>-115.13722}}, {"zip"=>"08002", "city"=>"Cherry Hill", "state"=>"New Jersey", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>39.93484, "lon"=>-75.03073}}, {"zip"=>"08755", "city"=>"Toms River", "state"=>"New Jersey", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>39.95373, "lon"=>-74.19792}}, {"zip"=>"11235", "city"=>"Brooklyn", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"10549", "city"=>"Mount Kisco", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>41.20426, "lon"=>-73.72708}}, {"zip"=>"10128", "city"=>"New York", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10314", "city"=>"Staten Island", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>40.56233, "lon"=>-74.13986}}, {"zip"=>"28601", "city"=>"Hickory", "state"=>"North Carolina", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>35.73319, "lon"=>-81.3412}}, {"zip"=>"45215", "city"=>"Cincinnati", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"73013", "city"=>"Edmond", "state"=>"Oklahoma", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>35.65283, "lon"=>-97.4781}}, {"zip"=>"73118", "city"=>"Oklahoma City", "state"=>"Oklahoma", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>35.46756, "lon"=>-97.51643}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"38119", "city"=>"Memphis", "state"=>"Tennessee", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"75231", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"75243", "city"=>"Dallas", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"78229", "city"=>"San Antonio", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"76309", "city"=>"Wichita Falls", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>33.91371, "lon"=>-98.49339}}, {"zip"=>"98201", "city"=>"Everett", "state"=>"Washington", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clinical Research Site", "geoPoint"=>{"lat"=>47.97898, "lon"=>-122.20208}}], "centralContacts"=>[{"name"=>"Study Director", "role"=>"CONTACT", "email"=>"axs-05-mdd-401@axsome.com", "phone"=>"+1 (212) 332-5061"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Axsome Therapeutics, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
