Electroconvulsive Therapy and Neuroradiology

NCT ID: NCT04348825

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2018-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Electroconvulsive Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients, depression

Patients who receive ECT as part of clinical care

Electroconvulsive therapy

Intervention Type DEVICE

Healthy

Healthy controls who do not receive ECT but otherwise the same assessments.

No interventions assigned to this group

Patients, atrial fibrilation

Patients who receive Electro Cardio Version (ECV) due to Atrial Fibrilation

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electroconvulsive therapy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bergen

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ketil J Ødegaard, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25927716 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39567961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32408397 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/1032

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

fMRI Study of tES in Major Depression
NCT04031547 COMPLETED EARLY_PHASE1