{
  "FullStudy":{
    "Rank":217694,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518049",
          "OrgStudyIdInfo":{
            "OrgStudyId":"N-20110029"
          },
          "Organization":{
            "OrgFullName":"Aarhus University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Clinical Validation of the Rating Scale for Psychotic Depression (RAS-PD)"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 21, 2012",
          "StudyFirstSubmitQCDate":"January 21, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 12, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 14, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Søren Dinesen Østergaard",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Aarhus University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Søren Dinesen Østergaard",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to develop a scale to measure the severity of depression with psychotic symptoms (psychotic depression). Furthermore, we hope to detect potential biomarkers (substances in the blood) which can aid in the detection of psychotic depression.\n\nMain hypothesis: A clinically valid rating scale measuring the severity of psychotic depression can be developed."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Affective Disorders, Psychotic"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Affective Disorders, Psychotic",
              "Psychometrics",
              "Biological Markers"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"blood samples"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Actual"
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFulfilling ICD-10 criteria DF32.3 or DF33.3\nAt least 18 years old\nLegally competent\nInformed consent (oral & written)\n\nExclusion Criteria:\n\nInsufficient Danish Language skills\nModerate to severe dementia\nAbuse of psychoactive substances",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"inpatients or outpatients at Danish Psychiatric Hospitals fulfilling criteria for unipolar depression with psychotic symptoms.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Søren D Østergaard, MD",
                "OverallOfficialAffiliation":"Aahus University Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Unit for Psychiatric Research, Aalborg Psychiatric Hospital, Aarhus University Hospital",
                "LocationCity":"Aalborg",
                "LocationZip":"9000",
                "LocationCountry":"Denmark"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25462426",
                "ReferenceType":"result",
                "ReferenceCitation":"Østergaard SD, Pedersen CH, Uggerby P, Munk-Jørgensen P, Rothschild AJ, Larsen JI, Gøtzsche C, Søndergaard MG, Bille AG, Bolwig TG, Larsen JK, Bech P. Clinical and psychometric validation of the psychotic depression assessment scale. J Affect Disord. 2015 Mar 1;173:261-8. doi: 10.1016/j.jad.2014.11.012. Epub 2014 Nov 18."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001523",
                "ConditionMeshTerm":"Mental Disorders"
              },{
                "ConditionMeshId":"D000011618",
                "ConditionMeshTerm":"Psychotic Disorders"
              },{
                "ConditionMeshId":"D000019964",
                "ConditionMeshTerm":"Mood Disorders"
              },{
                "ConditionMeshId":"D000000341",
                "ConditionMeshTerm":"Affective Disorders, Psychotic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019967",
                "ConditionAncestorTerm":"Schizophrenia Spectrum and Other Psychotic Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafAsFound":"Psychotic",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5641",
                "ConditionBrowseLeafName":"Depression",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5644",
                "ConditionBrowseLeafName":"Depressive Disorder",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20419",
                "ConditionBrowseLeafName":"Mood Disorders",
                "ConditionBrowseLeafAsFound":"Affective Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafAsFound":"Disorders, Psychotic",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M2272",
                "ConditionBrowseLeafName":"Affective Disorders, Psychotic",
                "ConditionBrowseLeafAsFound":"Affective Disorders, Psychotic",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13959",
                "ConditionBrowseLeafName":"Schizophrenia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20422",
                "ConditionBrowseLeafName":"Schizophrenia Spectrum and Other Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}