Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT01869868
Status:
UNKNOWN
Last Update Posted:
2015-04-30
First Post:
2013-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurobiological Changes When Treating Depression With Electroconvulsive Therapy - a Longitudinal Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2013-06-02', 'studyFirstSubmitQcDate': '2013-06-02', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measures of hippocampal volume assessed by structural MRI', 'timeFrame': 'Three months'}, {'measure': 'fMRI BOLD resting state functional connectivity', 'timeFrame': '3 month'}, {'measure': 'fMRI BOLD responses during execution of emotional and reward processing tasks', 'timeFrame': '3 months'}, {'measure': 'Biomarkers of cell proliferation', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Relation between neurobiological changes and clinical and cognitive outcome', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.', 'detailedDescription': 'The study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ECT)at a psychiatric clinic. We will use a consecutive sampling method and patient referred for ECT by their psychiatrist will be screened for inclusion and asked for participation. Both in - and outpatients can be included. At three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with depression referred for ECT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major depressive disorder\n* depressive episode in bipolar disorder\n* age 18 - 65 years\n\nExclusion Criteria:\n\n* alcohol- and/or drug dependence or abuse in the past 3 months\n* severe/life-threatening medical disease\n* pregnancy\n* type I diabetes\n* neurodegenerative disorder\n* inability to give written informed consent to participation in the study\n* contradiction to MRI scanning.'}, 'identificationModule': {'nctId': 'NCT01869868', 'briefTitle': 'Neurobiological Changes When Treating Depression With Electroconvulsive Therapy - a Longitudinal Observational Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Neurobiological Changes and Clinical Outcome When Treating Depression With Electroconvulsive Therapy.', 'orgStudyIdInfo': {'id': 'LIU2012/310-31'}, 'secondaryIdInfos': [{'id': 'LinkoepingUniversity', 'type': 'OTHER', 'domain': 'LinkoepingUniversity'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depression, ECT'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S58185', 'city': 'Linköping', 'state': 'Östergötland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Pia Nordanskog, MD', 'role': 'CONTACT', 'email': 'pia.nordanskog@lio.se', 'phone': '+46101030000'}, {'name': 'Pia Nordanskog, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Linkoeping University, Linkoeping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Pia Nordanskog', 'investigatorAffiliation': 'Linkoeping University'}}}}