Electroconvulsive Therapy and Neuroradiology

Completed

• Conditions: Electroconvulsive Therapy; Depression
• Interventions: Device: Electroconvulsive therapy

• Registration Number: NCT04348825
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2018-09-19
• Study Completion: 2018-10-10
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2020-05
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients, depression	Electroconvulsive therapy	Patients who receive ECT as part of clinical care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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