Major Depressive Disorder 1FundECTNCT05135897
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
An observational study of Major Depressive Disorder 1 and Major Depressive Disorder, run by Haukeland University Hospital at 1 site in Norway.
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 electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder 1, Major Depressive Disorder, Healthy
- What is being tested?
- Electroconvulsive therapy and rTMS
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 27 Sep 2021to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients accepted for ECT or TMS at Haukeland University Hospital will be included. Control groups: Healthy controls undergoing the same investigations as the ECT and TMS patient groups, but not receiving any treatment
Who may be able to join
- ECT:
- Patients (>18) referred to the center of ECT and accepted for treatment
- because of moderate and severe depression
- fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
- In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
- There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).
Show all 16Show fewer
- TMS:
- Patients (>18) referred to the center of TMS and accepted for treatment
- because of moderate and severe depression
- fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
- In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
- There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).
- Healthy controls:
- Age and gender matched (to the patient groups).
- No history of psychiatric illness and no current depression.
- No contraindication for MRI scanning.
Who cannot join
- ECT / TMS treatment within the last 12 months.
- Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible).
- Patients who cannot participate in the MR scanning
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5021
Leila Frid
About this study
The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).
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 and TMS
Sample, three groups:
ECT: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with ECT.
TMS: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with TMS.
HC: = 50 age and gender matched healthy volunteers not receiving ECT nor TMS.
Observation time: six months, with the time points as specified below. ECT is typically given three times weekly, but exceptions may occur. Hence, time points are specified as the number of ECT treatments given rather than an exact number of days which will vary.
Tp1: 2 hours before the first treatment session (day 1, baseline), Tp2: 2 hours after the first treatment session (day 1), Tp3: before the 7th ECT session and corresponding time point for TMS (~ day 15), Tp4: 1-2 weeks after last treatment session (~ day 30 - 50), Tp5: 6 months after treatment (~ day 180),
Healthy controls are only assessed at Tp1,2,4,5
- Being tested
- Electroconvulsive therapy, rTMS
- Medical subject headings
- Major Depressive Disorder 1, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyDevice
Treatment with Electroconvulsive therapy
rTMSDevice
repetitive Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patients, depression, ECT | Patients in major depressive episode undergoing ECT Receives: Device: Electroconvulsive therapy | |
| Patients, depression, TMS | Patients in major depressive episode undergoing TMS Receives: Device: rTMS | |
| Healthy | Healthy controls who do not receive ECT nor TMS but otherwise the same assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebral Blood Flow from baseline
Estimated by Arterial Spin Labeling MRI
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Change in MADRS from baseline
Depression rating by MADRS score
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Secondary outcomes (5)
Change fraction of in Isotropic hindered water
Measured by Restriction spectrum imaging. Increase in the fraction of isotropic hindered water as a sign of oedema / disruptive effects of ECT seen on Imaging at 2 hours after first ECT.
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Change in concentration of NAA, Choline, myo Inositol
MR Spectroscopy og the amygdala, measures of neuronal integrity.
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Changes in structural MRI T1 and T2 and RSI
Measures of brain structure
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Changes in functional MRI
Resting state MRI, measurement of functional connectivity
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Change in performance on test of spatial navigation
Neurocognitive assessments of spatial navigation
Measured: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (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 posted26 Nov 2021
- Study start27 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder 1Studies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135897
- Sponsor's protocol ID
- 254425
- Acronym
- FundECT
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frid LM, Kessler U, Ousdal OT, Hammar A, Haavik J, Riemer F, Hirnstein M, Ersland L, Erchinger VJ, Ronold EH, Nygaard G, Jakobsen P, Craven AR, Osnes B, Alisauskiene R, Bartsch H, Le Hellard S, Stavrum AK, Oedegaard KJ, Oltedal L. Neurobiological mechanisms of ECT and TMS treatment in depression: study protocol of a multimodal magnetic resonance investigation. BMC Psychiatry. 2023 Oct 30;23(1):791. doi: 10.1186/s12888-023-05239-0.
PubMed 37904091
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
- ClinicalTrials.gov ID
- NCT05135897
- Acronym / sponsor ID
- FundECT / 254425
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Nov 2021 (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 electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).
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 and TMS
Sample, three groups:
ECT: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with ECT.
TMS: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with TMS.
HC: = 50 age and gender matched healthy volunteers not receiving ECT nor TMS.
Observation time: six months, with the time points as specified below. ECT is typically given three times weekly, but exceptions may occur. Hence, time points are specified as the number of ECT treatments given rather than an exact number of days which will vary.
Tp1: 2 hours before the first treatment session (day 1, baseline), Tp2: 2 hours after the first treatment session (day 1), Tp3: before the 7th ECT session and corresponding time point for TMS (~ day 15), Tp4: 1-2 weeks after last treatment session (~ day 30 - 50), Tp5: 6 months after treatment (~ day 180),
Healthy controls are only assessed at Tp1,2,4,5
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients, depression, ECT | – | Device: Electroconvulsive therapyPatients in major depressive episode undergoing ECT |
| Patients, depression, TMS | – | Device: rTMSPatients in major depressive episode undergoing TMS |
| Healthy | – | –Healthy controls who do not receive ECT nor TMS but otherwise the same assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients accepted for ECT or TMS at Haukeland University Hospital will be included. Control groups: Healthy controls undergoing the same investigations as the ECT and TMS patient groups, but not receiving any treatment
Key inclusion criteria (16 listed)
- Patients (>18) referred to the center of ECT and accepted for treatment
- because of moderate and severe depression
- fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
- In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
- There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).
Key exclusion criteria (3 listed)
- ECT / TMS treatment within the last 12 months.
- Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible).
- Patients who cannot participate in the MR scanning
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 therapyTreatment with Electroconvulsive therapy | Device | Patients, depression, ECT |
| rTMSrepetitive Transcranial Magnetic Stimulation | Device | Patients, depression, TMS |
Primary outcome
Change in Cerebral Blood Flow from baseline
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Estimated by Arterial Spin Labeling MRI
Change in MADRS from baseline
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Depression rating by MADRS score
5 secondary outcomes
Change fraction of in Isotropic hindered water
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Change in concentration of NAA, Choline, myo Inositol
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Changes in structural MRI T1 and T2 and RSI
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Changes in functional MRI
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Change in performance on test of spatial navigation
Time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 37904091Frid LM, Kessler U, Ousdal OT, Hammar A, Haavik J, Riemer F, Hirnstein M, Ersland L, Erchinger VJ, Ronold EH, Nygaard G, Jakobsen P, Craven AR, Osnes B, Alisauskiene R, Bartsch H, Le Hellard S, Stavrum AK, Oedegaard KJ, Oltedal L. Neurobiological mechanisms of ECT and TMS treatment in depression: study protocol of a multimodal magnetic resonance investigation. BMC Psychiatry. 2023 Oct 30;23(1):791. doi: 10.1186/s12888-023-05239-0.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder 1 and Major Depressive Disorder, run by Haukeland University Hospital at 1 site in Norway.
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 16 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leif Oltedal, PhD (+47 5597388, leif.oltedal@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cerebral Blood Flow from baseline (time frame: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (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 NCT05135897, which also lists 1 linked publication.
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 26 Nov 2021.