Electroconvulsive Therapy and Neuroradiology (ECTMRI)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Electroconvulsive Therapy
• Intervention / Treatment: Device: Electroconvulsive therapy

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 Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Forty patients accepted for ECT at Haukeland University Hospital will be included.

Control groups: A group of patients undergoing Electrocardioversion (ECV) for atrial fibrilation (AF) (controls 1) and healthy controls undergoing the same investigations as the ECT patient group, but not receiving ECT or anesthesia (controls 2).

Description

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients, depression; Patients who receive ECT as part of clinical care	Device: Electroconvulsive therapy
Healthy; 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

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)

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Ketil J Ødegaard, PhD, Haukeland University Hospital

Publications and helpful links

General Publications

• Oltedal L, Kessler U, Ersland L, Gruner R, Andreassen OA, Haavik J, Hoff PI, Hammar A, Dale AM, Hugdahl K, Oedegaard KJ. Effects of ECT in treatment of depression: study protocol for a prospective neuroradiological study of acute and longitudinal effects on brain structure and function. BMC Psychiatry. 2015 May 1;15:94. doi: 10.1186/s12888-015-0477-y.
• Blomberg MO, Semkovska M, Kessler U, Erchinger VJ, Oedegaard KJ, Oltedal L, Hammar A. A Longitudinal Comparison Between Depressed Patients Receiving Electroconvulsive Therapy and Healthy Controls on Specific Memory Functions. Prim Care Companion CNS Disord. 2020 May 14;22(3):19m02547. doi: 10.4088/PCC.19m02547.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2013/1032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No