{
  "FullStudy":{
    "Rank":218241,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510886",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NIS-NES-XXX-2011/3"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"PismaEP"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"AstraZeneca",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Assessment of MDD Management in Andalusia",
          "OfficialTitle":"Assessment of MDD Management Strategies in Andalusia: A Sub-analysis of the PismaEP Study",
          "Acronym":"PismaEP"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 12, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"August 13, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"AstraZeneca",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The main objectives of this study are to describe medical professionals responsible of the management of patients with MDD in a representative region of Andalusia (in terms of type of sites managing the disease, and referral to SC criteria); Describe MDD patient characteristics at inclusion in the PISMA-Ep Study; and to evaluate those factors associated to a higher incidence of referral from PC to SC.",
          "DetailedDescription":"Assessment of MDD management strategies in Andalusia: A Sub-analysis of the PismaEP Study"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "MDD Management Strategies"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "MDD, management, Andalusia, Database, PismaEP"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Retrospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"5309",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"1"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of Visits to Primary Care",
                "PrimaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              },{
                "PrimaryOutcomeMeasure":"Number of Visits to Secondary Care",
                "PrimaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              },{
                "PrimaryOutcomeMeasure":"Number of Referrals",
                "PrimaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Demographics",
                "SecondaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              },{
                "SecondaryOutcomeMeasure":"Type of site",
                "SecondaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              },{
                "SecondaryOutcomeMeasure":"Type of therapeutic strategy",
                "SecondaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              },{
                "SecondaryOutcomeMeasure":"Type of disease",
                "SecondaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              },{
                "SecondaryOutcomeMeasure":"Severity of disease",
                "SecondaryOutcomeTimeFrame":"From Jan 2010 to Jan 2011"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMDD Diagnosis Participants of the PismaEP study 18 yo. or older\n\nExclusion Criteria:\n\nNo specific exclusion criteria",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"MDD patients treated in Primary Care or Secondary Care in the Region of Granada and recruited for the PISMA-Ep Study",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jorge Cervilla, MD",
                "OverallOfficialAffiliation":"Hospital San Cecilio",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Research Site",
                "LocationCity":"Granada",
                "LocationCountry":"Spain"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"NIS-NES-XXX-2011-3 Clinical Study Report Synopsis",
                "SeeAlsoLinkURL":"http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=924&filename=NIS-NES-XXX-2011-3_Clinical_Study_Report_Synopsis.pdf"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}