Depression, Electroconvulsive Therapy
Conditions
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.
Interventions
DEVICEElectroconvulsive therapy
Sponsors
University of Bergen
Haukeland University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters | 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 | Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) | Symptoms scores on Montgomery-Åsberg Depression Rating Scale (MADRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Neurocognitive functioning | Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment) | Neurocognitive assessments |
Outcome results
None listed