Electroconvulsive Therapy and Neuroradiology (ECTMRI)
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|ClinicalTrials.gov Identifier: NCT04348825|
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
|Condition or disease||Intervention/treatment|
|Depression Electroconvulsive Therapy||Device: Electroconvulsive therapy|
As a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. The aim is to document both treatment effects and potential harmful effects of ECT.
Sample: n = 40 patients in a major depressive episode (bipolar and major depressive disorder). Two control groups with n = 15 in each group: age and gender matched healthy volunteers not receiving ECT and patients undergoing electrical cardioversion (ECV) for atrial fibrillation (AF). Observation time: six months.
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function|
|Actual Study Start Date :||September 1, 2013|
|Actual Primary Completion Date :||September 19, 2018|
|Actual Study Completion Date :||October 10, 2018|
Patients who receive ECT as part of clinical care
Device: Electroconvulsive therapy
Healthy controls who do not receive ECT but otherwise the same assessments.
Patients, atrial fibrilation
Patients who receive Electro Cardio Version (ECV) due to Atrial Fibrilation
- Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters [ Time Frame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) ]MRI of the brain is segmented into Regions of Interest by automated processing pipelines
- Changes from baseline in Depression ratings [ Time Frame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) ]Symptoms scores on MADRS
- Changes from baseline in Neurocognitive functioning [ Time Frame: Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) ]Neurocognitive assessments
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348825
|Principal Investigator:||Ketil J Ødegaard, PhD||Haukeland University Hospital|