{
  "FullStudy":{
    "Rank":217650,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518634",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011-004294-87"
          },
          "Organization":{
            "OrgFullName":"University of Aarhus",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome",
          "OfficialTitle":"Treatment of Multi-organ Bodily Distress Syndrome. A Double-blinded Placebo Controlled Trial of the Effects of Imipramine (Stress-3)",
          "Acronym":"Stress-3"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 8, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 9, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Aarhus",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in patients with longlasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing both pain and other symptoms of bodily distress for patients with BDS. Control conditions are pill placebo. Study duration is 19 weeks for each of the 140 patients. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug.",
          "DetailedDescription":"The aim of this study is to test the effect of Imipramine in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a double-blinded placebo controlled trial of treatment with the tricyclic antidepressant Imipramine in dosages of 25-75 mg. Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study requires 140 participants and study duration is 19 weeks for each patient. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Somatisation Disorder",
              "Somatoform Disorders"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Bodily Distress Syndrome",
              "Medically unexplained symptoms",
              "Functional somatic symptoms",
              "Functional somatic syndromes",
              "Treatment",
              "Imipramine",
              "Tricyclic antidepressant"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"138",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Imipramine treatment",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Imipramine treatment"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Imipramine treatment",
                "InterventionDescription":"Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Imipramine treatment"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Global Clinical Improvement Scale",
                "PrimaryOutcomeDescription":"Questionnaire, patient-rated improvement of health since the beginning of the study.",
                "PrimaryOutcomeTimeFrame":"After 13 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"SF-36",
                "SecondaryOutcomeDescription":"Questionnaire, patient-rated. Assessment of physical, social and mental functioning",
                "SecondaryOutcomeTimeFrame":"At 1 and 13 weeks"
              },{
                "SecondaryOutcomeMeasure":"Visual Analogue Scale for pain and worst symptom",
                "SecondaryOutcomeTimeFrame":"At 1 and 13 weeks"
              },{
                "SecondaryOutcomeMeasure":"Symptom Checklist (SCL)",
                "SecondaryOutcomeTimeFrame":"At 1, 3 and 13 weeks"
              },{
                "SecondaryOutcomeMeasure":"Functional Illness Checklist (FIC)",
                "SecondaryOutcomeTimeFrame":"At 1, 3 and 13 weeks"
              },{
                "SecondaryOutcomeMeasure":"WHODAS II",
                "SecondaryOutcomeTimeFrame":"At 1 and 13 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFirst time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories\nModerate or severe impact on daily life\nSymptoms lasting for at least 2 years\nAge 20-50 years\nBorn in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.\n\nExclusion Criteria:\n\nPresence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS\nCurrent moderate or severe depression, patients in continuous antidepressant treatment because of moderate or severe depression, and patients with other severe psychiatric disorder that demands treatment, or if the patient is suicidal.\nA lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)\nAbuse of alcohol, narcotics or drugs\nPregnancy, breastfeeding or current pregnancy wish. Fertile women must use effective anticonception, (hormonal contraception, contraceptive injection, implant or patches, intrauterine system and device, vaginal ring).\nTreatment with all pain modulating drugs, e.g. all analgesics, antidepressants, antiepileptica and other types of medication with pain relieving properties must be discontinued at least two weeks before the treatment phase.\nImipramine treatment in sufficient dosage within the last year, i.e. 25 mg daily continuously for at least 8 weeks.\nAllergy to study medication or excipients in study medication.\nPatients with previous med myocardial infarction, congestive heart failure, signs of conduction defects or abnormalities on ECG (first degree AV-block, bundle branch block or prolonged QT-interval), narrow-angle glaucoma, porphyria, inherited galactose intolerance, epilepsy, hepatic insufficiency and severe renal impairment\n\nSimultaneous use of:\n\nantipsychotics\noral anticoagulants\ndiuretics\nsympathomimetics and CNS-stimulating drugs (amphetamine-like drugs)\nall serotonergic drugs, e.g. SSRI, SNRI and TCA, the dietary supplement hypericum perforatum, non-selective, irreversible or selective, reversible monoamine oxidase (MAO) inhibitors, triptans, tramadol, pethidin and tryptophan\nthe drugs cimetidine (H2-antagonist), quinidine (antiarrythmics), clonidine (antihypertensive), fluconazol (antimycotics), clindamycin, clarithromycin, erythromycin (antibiotics), droperidol (anaesthetic), levodopa (antiparkinson), mefloquine (antimalaria), phenytoin, barbiturates, carbamazepin (antiepileptica)\nBupropion (tobacco dependence), celecoxib (NSAID), cinacalcet (antiparathyroid drug), duloxetine (SNRI), flufenazin (antipsychotic), fluoxetin (SSRI), gefitinib (antineoplastic), moclobemid (MAO), paroxetine, Sertraline (SSRI), Terbinafine (antimycotics), Yohimbin (erectile dysfunction) samt fluvoxamin (SSRI), ciprofloxacin and enoxacin (microbiotic), because plasma concentration of Imipramine can increase with the simultaneous use of these potent CYP2D6- and CYP1A2- inhibitors",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Per k Fink, dr.med",
                "OverallOfficialAffiliation":"Research Clinic for Functional Disorders, Aarhus University Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Research Clinic for Functional Disorders",
                "LocationCity":"Aarhus",
                "LocationZip":"8000",
                "LocationCountry":"Denmark"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"28408193",
                "ReferenceType":"result",
                "ReferenceCitation":"Agger JL, Schröder A, Gormsen LK, Jensen JS, Jensen TS, Fink PK. Imipramine versus placebo for multiple functional somatic syndromes (STreSS-3): a double-blind, randomised study. Lancet Psychiatry. 2017 May;4(5):378-388. doi: 10.1016/S2215-0366(17)30126-8. Epub 2017 Apr 10. Erratum in: Lancet Psychiatry. 2017 Jul;4(7):516."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000007099",
                "InterventionMeshTerm":"Imipramine"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000929",
                "InterventionAncestorTerm":"Antidepressive Agents, Tricyclic"
              },{
                "InterventionAncestorId":"D000000928",
                "InterventionAncestorTerm":"Antidepressive Agents"
              },{
                "InterventionAncestorId":"D000011619",
                "InterventionAncestorTerm":"Psychotropic Drugs"
              },{
                "InterventionAncestorId":"D000018759",
                "InterventionAncestorTerm":"Adrenergic Uptake Inhibitors"
              },{
                "InterventionAncestorId":"D000014179",
                "InterventionAncestorTerm":"Neurotransmitter Uptake Inhibitors"
              },{
                "InterventionAncestorId":"D000049990",
                "InterventionAncestorTerm":"Membrane Transport Modulators"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000018663",
                "InterventionAncestorTerm":"Adrenergic Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M8730",
                "InterventionBrowseLeafName":"Imipramine",
                "InterventionBrowseLeafAsFound":"Imipramine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2828",
                "InterventionBrowseLeafName":"Antidepressive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2829",
                "InterventionBrowseLeafName":"Antidepressive Agents, Tricyclic",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M13057",
                "InterventionBrowseLeafName":"Psychotropic Drugs",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19330",
                "InterventionBrowseLeafName":"Adrenergic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"PsychDr",
                "InterventionBrowseBranchName":"Psychotropic Drugs"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004194",
                "ConditionMeshTerm":"Disease"
              },{
                "ConditionMeshId":"D000013577",
                "ConditionMeshTerm":"Syndrome"
              },{
                "ConditionMeshId":"D000013001",
                "ConditionMeshTerm":"Somatoform Disorders"
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            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafAsFound":"Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M885",
                "ConditionBrowseLeafName":"Medically Unexplained Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14386",
                "ConditionBrowseLeafName":"Somatoform Disorders",
                "ConditionBrowseLeafAsFound":"Somatoform Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}