{
  "FullStudy":{
    "Rank":217971,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514435",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BRECT-2006-PET"
          },
          "Organization":{
            "OrgFullName":"Medical University of Graz",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)",
          "OfficialTitle":"Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2009",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 17, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 23, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Medical University of Graz",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"There exist already a few studies that have measured changes of brain metabolism pre and post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all performed in a small number of patients and used different methodologies. It is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 Schmidt,E.Z. 2008}}.\n\nIn patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur after treatment with ECT and (b) whether these correlate with the clinical amelioration of symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at the end of treatment.\n\nPatients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively asked for participation in this study. Patients had to be between 18 and 80 years old and to be physically healthy."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Major Depressive Disorder"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "depression",
              "FDG-PET",
              "Electroconvulsive therapy",
              "glucose metabolism"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"13",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"ECT verum group",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients with treatment refractory depression treated with ECT",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Electroconvulsive therapy",
                    "Device: 18-Fluoro-desoxy-glucose positron emission tomography"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Electroconvulsive therapy",
                "InterventionDescription":"treatment for major depression",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "ECT verum group"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "no other names"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"18-Fluoro-desoxy-glucose positron emission tomography",
                "InterventionDescription":"intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min.\n\nIt´s a neuroimaging technique.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "ECT verum group"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "no other names"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Brain glucose metabolism measured by FDG-PET",
                "PrimaryOutcomeTimeFrame":"one year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nclinical indication for ECT\ntreatment refractory depressive episode\nage 18-85 y\n\nExclusion Criteria:\n\naddiction as a first diagnosis\ndementia",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"85 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Bernd Reininghaus",
                "OverallOfficialAffiliation":"Medical University of Graz",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Medical University Graz; Department for Psychiatry",
                "LocationCity":"Graz",
                "LocationState":"Styria",
                "LocationZip":"8036",
                "LocationCountry":"Austria"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"17444078",
                "ReferenceType":"background",
                "ReferenceCitation":"Berlim MT, Turecki G. Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods. Can J Psychiatry. 2007 Jan;52(1):46-54. Review."
              },{
                "ReferencePMID":"17662472",
                "ReferenceType":"background",
                "ReferenceCitation":"Schmidt EZ, Reininghaus B, Enzinger C, Ebner C, Hofmann P, Kapfhammer HP. Changes in brain metabolism after ECT-positron emission tomography in the assessment of changes in glucose metabolism subsequent to electroconvulsive therapy--lessons, limitations and future applications. J Affect Disord. 2008 Feb;106(1-2):203-8. Epub 2007 Jul 26. Review."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003866",
                "ConditionMeshTerm":"Depressive Disorder"
              },{
                "ConditionMeshId":"D000003865",
                "ConditionMeshTerm":"Depressive Disorder, Major"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019964",
                "ConditionAncestorTerm":"Mood Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5641",
                "ConditionBrowseLeafName":"Depression",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5644",
                "ConditionBrowseLeafName":"Depressive Disorder",
                "ConditionBrowseLeafAsFound":"Depressive Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5643",
                "ConditionBrowseLeafName":"Depressive Disorder, Major",
                "ConditionBrowseLeafAsFound":"Major Depressive Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20419",
                "ConditionBrowseLeafName":"Mood Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}