{
  "FullStudy":{
    "Rank":217780,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516931",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Huaning Wang"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"XijingH",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"XijingH"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Xijing Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Depression",
          "OfficialTitle":"A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Depression."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2020",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 1, 2013",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 30, 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 25, 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 29, 2011",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 8, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 13, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Huaning Wang",
            "ResponsiblePartyInvestigatorTitle":"director of department",
            "ResponsiblePartyInvestigatorAffiliation":"Xijing Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Xijing Hospital",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"The No.3 hospital of PLA",
                "CollaboratorClass":"UNKNOWN"
              },{
                "CollaboratorName":"The No.91 hospital of PLA",
                "CollaboratorClass":"UNKNOWN"
              },{
                "CollaboratorName":"No. 102 Hospital of Chinese People's Liberation Army",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale.",
          "DetailedDescription":"Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of depression.Depression is a chronic illness and generally requires life-long treatment. However, up to current days there have been no studies evaluating the effects of rTMS in the maintenance treatment of depression. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of rTMS, as monotherapy, relative to placebo in delaying the time to relapse in patients with depression. Patients with acute symptoms of depression will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. The study will consist of 4 phases: a screening/tolerability phase of up to 7 days; an open-label, flexible-dose lead-in phase of 8 weeks; an open-label, fixed-dose stabilization phase of 6 weeks; and a single-blind relapse prevention phase of 12 months. During the open-label phase, all patients will be treated with venlafaxine. Remitterswith Hamilton Rating Scale for Depression [HAM-D17] score ≤ 7will be eligible to enter the single-blind phase and will be randomly assigned to one of three groups: group 1 on active rTMS and venlafaxine; group 2 on sham rTMS and venlafaxine; group 3 on venlafaxine alone. Efficacy will be evaluated during the study using relapse assessment (time between subject randomization to treatment and the first occurrence of relapse). Secondary outcome measures will include: symptom changes, measured by the Hamilton Rating Scale for Depression [HAM-D17]; illness severity changes, measured by the Clinical Global Impression of Severity for Depression (CGI-S-DEP); and changes in subject functioning, assessed with the Personal and Social Performance Scale. Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiography, and measurements of vital signs (temperature, pulse and blood pressure) and weight. Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Depression"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "repetitive Transcranial Magnetic Stimulation (rTMS)",
              "Depression",
              "Venlafaxine",
              "Relapse"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignInterventionModelDescription":"rTMS intervention",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"391",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"active rTMS and venlafaxine",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"rTMS：Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.\n\nvenlafaxine：150-225mg/day",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)"
                  ]
                }
              },{
                "ArmGroupLabel":"sham rTMS and venlafaxine",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Sham stimulation will be given at the same site and frequency, using a Magstim sham-coil system. During rTMS, participants will be instructed to keep their eyes open and relax.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: counseling"
                  ]
                }
              },{
                "ArmGroupLabel":"venlafaxine alone",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"responders will be maintained on the same effective dose of venlafaxine for the entire duration of the RCT, unless they relapse and will have to exit the protocol and enter a naturalistic follow-up",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: counseling"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"repetitive Transcranial Magnetic Stimulation (rTMS)",
                "InterventionDescription":"1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "active rTMS and venlafaxine"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"counseling",
                "InterventionDescription":"Placebo monthly by general counseling for 12 months.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "sham rTMS and venlafaxine",
                    "venlafaxine alone"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Time for relapse",
                "PrimaryOutcomeDescription":"Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period",
                "PrimaryOutcomeTimeFrame":"Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Hamilton Depression Rating Scale",
                "SecondaryOutcomeDescription":"Reduction on the scores of HDRS (as on the scores of Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life)",
                "SecondaryOutcomeTimeFrame":"baseline and 15 months"
              },{
                "SecondaryOutcomeMeasure":"Illness severity change",
                "SecondaryOutcomeDescription":"Illness severity change as measured by Clinical Global Impression of Severity for depression.",
                "SecondaryOutcomeTimeFrame":"baseline and 15 months"
              },{
                "SecondaryOutcomeMeasure":"subject functioning",
                "SecondaryOutcomeDescription":"Change in subject functioning using the Personal and Social Performance Scale (PSP)",
                "SecondaryOutcomeTimeFrame":"baseline and 15 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDSM-IV diagnosis of depression\nExperiencing an acute exacerbation of depression symptoms\nBaseline score of at least 14 points on the Hamilton Depression rating Scale-17 items\nHealthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements\n\nExclusion Criteria:\n\nComprised ferromagnetic metallic implants\nPacemakers\nPrevious neurosurgery\nHistory of seizures\nMajor head trauma\nAlcoholism\nDrug addiction\nAny psychiatric or neurological disorder other than depression and anxiety\nPsychotic depression\nSuicidal propensities",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Qingrong",
                "LocationCity":"Xi'an",
                "LocationState":"Shaanxi",
                "LocationZip":"710032",
                "LocationCountry":"China"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24135054",
                "ReferenceType":"derived",
                "ReferenceCitation":"Wang H, Xue Y, Chen Y, Zhang R, Wang H, Zhang Y, Gan J, Zhang L, Tan Q. Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial. Trials. 2013 Oct 17;14:338. doi: 10.1186/1745-6215-14-338."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012008",
                "ConditionMeshTerm":"Recurrence"
              },{
                "ConditionMeshId":"D000003863",
                "ConditionMeshTerm":"Depression"
              },{
                "ConditionMeshId":"D000003866",
                "ConditionMeshTerm":"Depressive Disorder"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001526",
                "ConditionAncestorTerm":"Behavioral Symptoms"
              },{
                "ConditionAncestorId":"D000019964",
                "ConditionAncestorTerm":"Mood Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              },{
                "ConditionAncestorId":"D000020969",
                "ConditionAncestorTerm":"Disease Attributes"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5641",
                "ConditionBrowseLeafName":"Depression",
                "ConditionBrowseLeafAsFound":"Depression",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5644",
                "ConditionBrowseLeafName":"Depressive Disorder",
                "ConditionBrowseLeafAsFound":"Depression",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13433",
                "ConditionBrowseLeafName":"Recurrence",
                "ConditionBrowseLeafAsFound":"Relapse",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3399",
                "ConditionBrowseLeafName":"Behavioral Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20419",
                "ConditionBrowseLeafName":"Mood Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21284",
                "ConditionBrowseLeafName":"Disease Attributes",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}