Nctid:
NCT06232291
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003863", "term"=>"Depression"}, {"id"=>"D003866", "term"=>"Depressive Disorder"}, {"id"=>"D003865", "term"=>"Depressive Disorder, Major"}, {"id"=>"D061218", "term"=>"Depressive Disorder, Treatment-Resistant"}], "ancestors"=>[{"id"=>"D001526", "term"=>"Behavioral Symptoms"}, {"id"=>"D019964", "term"=>"Mood Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "asFound"=>"Depression", "relevance"=>"HIGH"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "asFound"=>"Depression", "relevance"=>"HIGH"}, {"id"=>"M7060", "name"=>"Depressive Disorder, Major", "asFound"=>"Major Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M29783", "name"=>"Depressive Disorder, Treatment-Resistant", "asFound"=>"Treatment Resistant Depression", "relevance"=>"HIGH"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}, {"id"=>"M21835", "name"=>"Mood Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10674", "name"=>"Ketamine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"ECOLOGIC_OR_COMMUNITY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>3}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-04-21", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2024-05-24", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-05-25", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-24", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Safety record post IMP exposure.", "timeFrame"=>"Single psychometric assessment is performed along with a structured interview covering a period of 12 months after participation in the study.", "description"=>"time to event and its nature: exacerbation of symptoms, hospitalization, change of treatment, functional disorders requiring social support."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Treatment-Resistant Depression", "Major Depressive Disorder"]}, "descriptionModule"=>{"briefSummary"=>"An observational-comparative study, without interfering with the treatment, based on an operationalized interview.", "detailedDescription"=>"Patients with treatment-resistant depression constitute a significant proportion (even 30%) of patients diagnosed with major depressive disorder (MDD. Since 2014, there have been reports of a potential antidepressant effect of the R-ketamine stereoisomer. At the UCK Department of Psychiatry, a phase 2 clinical trial (2a) has been conducted since 2022 with the use of R-ketamine in the form of an intravenous solution, administered by an infusion pump to patients with drug-resistant depression (sponsor Perception Neuroscience, Inc., protocol PCN-101-21, NCT05414422). The available data from studies indicate a potential treatment-transformative effect of the drug, but do not provide comprehensive information on the long-term effects of treatment in terms of effectiveness, tolerability, and safety of R-ketamine use. The study is cognitive and comparative study, without interfering with the diagnostics, treatment, and rehabilitation. It aims to collect effectiveness and safety observations within 12 months of participation in the PCN-101-21 study, at quarterly intervals (3, 6, 9, 12 months, +/- 4 weeks), with particular emphasis on exacerbations of the underlying disease, hospitalization, correction of psychotropic treatment or functional impairment requiring support from social security authorities. The study does not involve additional diagnostic, therapeutic or rehabilitation goals and is a retrospective analysis performed during a single visit."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients participating in the PCN-101-21 study from March 4, 2022, on site.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nExpressing informed consent to participate in the study and earlier participation in the PCN-101-21 study on site.\n\nExclusion Criteria:\n\nInformed consent withdrawal."}, "identificationModule"=>{"nctId"=>"NCT06232291", "briefTitle"=>"Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression", "organization"=>{"class"=>"OTHER", "fullName"=>"Medical University of Gdansk"}, "officialTitle"=>"Observation of Safety and Tolerability Within 1 Year of the Use of R-ketamine / Placebo in Drug-resistant Depression", "orgStudyIdInfo"=>{"id"=>"NKBBN/12/2023"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"80-214", "city"=>"Gdańsk", "country"=>"Poland", "facility"=>"Medical University of Gdańsk", "geoPoint"=>{"lat"=>54.35205, "lon"=>18.64637}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "ICF", "CSR"], "ipdSharing"=>"YES", "description"=>"data repository at site, available on request"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical University of Gdansk", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Perception Neuroscience", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
