[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366908":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":53,"collaborators":36,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":36,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":36,"enrollmentInfo":64,"targetDuration":36,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":36,"overallStatus":41,"whyStopped":36,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Region Örebro County","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"0.5 ms pulse width stimulus","ACTIVE_COMPARATOR","Electroconvulsive therapy initiated with 0.5 ms pulse width stimulus",[13],"Device: Electroconvulsive therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"1.0 ms pulse width stimulus","Electroconvulsive therapy initiated with 1.0 ms pulse width stimulus",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Electroconvulsive therapy","Electrically induced convulsion under anesthesia",[9,15],[25],"ECT",[27],{"name":28,"affiliation":29,"role":30},"Axel Nordenskjöld","Örebro University, Region Örebro län","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Axel Nordenskjöld, MD, PhD","CONTACT","+46196021000",null,"axel.nordenskjold@regionorebrolan.se",[39],{"facility":40,"status":41,"city":42,"state":36,"zip":36,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University hospital Örebro","RECRUITING","Örebro","Sweden","SE",{"type":46,"coordinates":47},"Point",[48,49],15.2066,59.27412,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":36,"phoneExt":36,"email":36},{"type":54,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100366908","phase-4-optimal-electrical-stimulus-during-electroconvulsive-therapy-100366908",false,"NCT04057378","Optimal Electrical Stimulus During Electroconvulsive Therapy","Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial","Inclusion Criteria:\n\n* At least 18 years old at the time of inclusion\n* Fulfilled diagnostic criteria for unipolar, or bipolar depressive episode according to ICD-10.\n* Has indication for and accepts ECT\n* Has a Swedish personal identity number\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n• If the investigator judges a certain pulse width to be inappropriate for the patient.","ALL","18 Years",{"count":65,"type":66},800,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","Synopsis\n\nAim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli.\n\nDesign: National, register-based randomized trial, unmasked with two treatment arms.\n\nPrimary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (\\\u003C 11 on the MADRS-S) than a 0.5ms pulse width stimulus.\n\nSecondary objectives include testing for differences in:\n\nself-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm.\n\nInclusion criteria:\n\nAt least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10.\n\nAn indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent.\n\nExclusion criteria:\n\nIf the investigator judges a certain pulse width to be inappropriate for the patient.\n\nInclusion time 2019-05-01-2022-11-15.\n\nAbbreviations\n\n1. CGI: Clinical Global Impression Scale\n2. CPRS: The Comprehensive Psychopathological Rating Scale\n3. ECT: Electroconvulsive therapy\n4. EQ5D: EuroQual-group 5 Dimensions Scale\n5. ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision,\n6. MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version.\n7. Q-ECT: Swedish national quality register for ECT\n8. VAS: Visual analogue scale",[72,73],"Depressive Disorder, Major","Depression, Bipolar","2025-06-17",{"date":76,"type":77},"2025-06-22","ACTUAL",{"date":79,"type":77},"2019-10-30",{"date":81,"type":66},"2027-11-15",{"name":5,"class":6},1]