Electroconvulsive Therapy and Neuroradiology

Study Overview
=================
Brief Summary
-----------------
The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of ECT.

Detailed Description
-----------------
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.

Official Title
-----------------
Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function

Conditions
-----------------
Depression, Electroconvulsive Therapy

Intervention / Treatment
-----------------
* Device: Electroconvulsive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (age > 18) referred to the ECT-unit and accepted for treatment because of moderate and severe depression, fulfilling the criteria for the following ICD-10 diagnoses: F31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3. symptom intensity must be verified by a score ≥ 25 on the Montgomery and Åsberg Depression Rating Scale (MADRS). Exclusion Criteria: ECT treatment within the last 12 months. Pregnancy. Patients unable to give written informed consent (according to the responsible clinician or ECT responsible). Patients who cannot participate in the MRI scanning because of contraindications to MRI.

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients, depression<br>Patients who receive ECT as part of clinical care | Device: Electroconvulsive therapy<br> <br> |
| Healthy<br>Healthy controls who do not receive ECT but otherwise the same assessments. | |
| Patients, atrial fibrilation<br>Patients who receive Electro Cardio Version (ECV) due to Atrial Fibrilation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters | MRI of the brain is segmented into Regions of Interest by automated processing pipelines | Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) | 
| Changes from baseline in Depression ratings | Symptoms scores on Montgomery-Åsberg Depression Rating Scale (MADRS) | Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Neurocognitive functioning | Neurocognitive assessments | Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) |