DepressionECTMRINCT04348825
Electroconvulsive Therapy and Neuroradiology
An observational study of Depression and Electroconvulsive Therapy, run by Haukeland University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Electroconvulsive Therapy
- What is being tested?
- Electroconvulsive therapy
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2013to 10 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Electroconvulsive Therapy
- Being tested
- Electroconvulsive therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients, depression | Patients who receive ECT as part of clinical care Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters
MRI of the brain is segmented into Regions of Interest by automated processing pipelines
Measured: 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)
Measured: 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
Neurocognitive assessments
Measured: Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Sep 2013
- Primary completion19 Sep 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Ketil J Ødegaard, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348825
- Sponsor's protocol ID
- 2013/1032
- Acronym
- ECTMRI
- Status last verified
- May 2020
- First submitted
- 14 Apr 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25927716Hammar 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.
PubMed 39567961Blomberg 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.
PubMed 32408397
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of ECT in Treatment of Major Depression: A Prospective Neuroradiological Study of Acute and Longitudinal Effects on Brain Structure and Function
- ClinicalTrials.gov ID
- NCT04348825
- Acronym / sponsor ID
- ECTMRI / 2013/1032
- Conditions
- Depression, Electroconvulsive Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients, depression | – | Device: Electroconvulsive therapyPatients who receive ECT as part of clinical care |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive therapy | Device | Patients, depression |
Primary outcome
Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters
Time frame: 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
Time frame: 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)
1 secondary outcome
Changes from baseline in Neurocognitive functioning
Time frame: Before (baseline), after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 25927716Oltedal 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.
- Derived from this study: PubMed 39567961Hammar 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.
- Derived from this study: PubMed 32408397Blomberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketil J Ødegaard, PhD principal investigator
Haukeland University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Electroconvulsive Therapy, run by Haukeland University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in Magnetic Resonance Imaging (MRI) derived parameters (time frame: Before (baseline), during, after (typically 1-2 weeks after last ECT) and at follow up (6 months after treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348825, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.