Electroconvulsive Therapy and Neuroradiology

NCT04348825 | Completed

• 1 other identifier: 2013/1032
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes from baseline in Neurocognitive functioning

  Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)

Study Arms (3)

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

Interventions

Electroconvulsive therapy DEVICE

Patients, depression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Related Publications (3)

• 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.

  PMID: 25927716 BACKGROUND

• Hammar A, Ronold EH, Spurkeland MA, Ueland R, Kessler U, Oedegaard KJ, Oltedal L. Improvement of persistent impairments in executive functions and attention following electroconvulsive therapy in a case control longitudinal follow up study. BMC Psychiatry. 2024 Nov 20;24(1):832. doi: 10.1186/s12888-024-06270-5.

  PMID: 39567961 DERIVED

• 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.

  PMID: 32408397 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ketil J Ødegaard, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: September 1, 2013
• Primary Completion: September 19, 2018
• Study Completion: October 10, 2018
• Last Updated: February 28, 2024

Record last verified: 2020-05