Nctid:
NCT06235905
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003866", "term"=>"Depressive Disorder"}, {"id"=>"D000003863", "term"=>"Depression"}, {"id"=>"D000003865", "term"=>"Depressive Disorder, Major"}], "ancestors"=>[{"id"=>"D000019964", "term"=>"Mood Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depressive Disorder", "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"=>"M21835", "name"=>"Mood Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"Open-label"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-10-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-06", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-07", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Evaluation of the efficacy of SPN-820 administered once every 3 days as measured by the Hamilton Depression Rating Scale-6 Items", "timeFrame"=>"10 days", "description"=>"Change from baseline to each time point in the Hamilton Depression Rating Scale-6 Items (HAM-D6).\n\nThe HAM-D6 scale consists of 6 items: five of them (Depressed Mood, Self-esteem and Guilt, Social Life Activities/Interests, General Psychomotor Retardation, and Psychic Anxiety) are scored on a scale of 0 to 4, and one item (Tiredness and Pains) is scored on a scale 0-2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes."}], "secondaryOutcomes"=>[{"measure"=>"Evaluation of the efficacy as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) score", "timeFrame"=>"10 days", "description"=>"Change from baseline to each time point in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.\n\nMADRS is a 10-item scale: (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression and lower scores, better outcomes."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Major Depressive Disorder"]}, "descriptionModule"=>{"briefSummary"=>"This study will evaluate the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)", "detailedDescription"=>"This is an open-label, single-group study of adjunctive SPN-820 in adults with MDD"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Male or female subject, aged 18 to 65 years (inclusive) at screening.\n* Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening.\n* MADRS total score of ≥22 for the current major depressive episode (MDE) at screening and baseline (day 1) before SM administration.\n* CGI-S score of ≥4 (moderately ill or worse) at screening and baseline (day 1) before SM administration.\n* Stable, therapeutic dose of one of the following protocol-defined ADTs for the current MDE for ≥4 weeks prior to screening: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (immediate release or extended release), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion, or dextromethorphan/bupropion.\n* Stable therapeutic dose of the approved ADT throughout the study.\n\nExclusion Criteria:\n\n* MADRS total score improvement of ≥25% from the highest to the lowest score from screening to baseline.\n* Clinically significant abnormal laboratory profiles, vital sign measurements, or ECGs prior to baseline.\n* History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features.\n* Diagnosis within the last 12 months before screening or current diagnosis of PTSD, OCD, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster A or B personality disorder.\n* Suicidal behavior or suicidal ideation of type 4 or type 5 based on the C-SSRS in the 2 years before screening; a history of suicide attempt in the last 6 months; or more than 2 lifetime suicide attempts.\n* History of substance use disorder within 6 months prior to screening or is currently using or has a positive result (urine drug screen) at screening or baseline for drugs of abuse.\n* History of alcohol use disorder within 6 months prior to screening.\n* In the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason."}, "identificationModule"=>{"nctId"=>"NCT06235905", "briefTitle"=>"Open-Label of SPN-820 in Adults With Major Depressive Disorder", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Navitor Pharmaceuticals, Inc."}, "officialTitle"=>"An Open-Label, Single-Group Study to Evaluate the Efficacy and Safety of SPN-820 in Adults With Major Depressive Disorder", "orgStudyIdInfo"=>{"id"=>"NAV-17A-008"}, "secondaryIdInfos"=>[{"id"=>"SPN-820", "type"=>"OTHER", "domain"=>"Supernus Pharmaceuticals"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"SPN-820 6 x 400 mg capsules", "interventionNames"=>["Drug: NV-5138"]}], "interventions"=>[{"name"=>"NV-5138", "type"=>"DRUG", "otherNames"=>["SPN-820"], "description"=>"NV-5138 is a novel , orally bioavailable, activator of mTORC1", "armGroupLabels"=>["SPN-820 6 x 400 mg capsules"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"14618", "city"=>"Rochester", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Muhammad Saleem Ismail", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}], "centralContacts"=>[{"name"=>"Gianpiera Ceresoli-Borroni, PhD", "role"=>"CONTACT", "email"=>"gceresoliborroni@supernus.com", "phone"=>"3018382521"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Navitor Pharmaceuticals, Inc.", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Supernus Pharmaceuticals, Inc.", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
