Major Depressive Disorder (MDD)A-TRECNCT07115628
Accelerated TMS for Treatment-Resistant ECT
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study investigates whether an additional treatment using transcranial magnetic stimulation (TMS) can help severely depressed patients who did not respond well to electroconvulsive therapy (ECT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Disorder (MDD)
- Age between 18 - 70 years
- Referred for ECT treatment
Who cannot join
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, abuse substance, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) except dental fill-ings and the presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with some neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with MRI
- Patients with cognitive disturbances or dementia (Mini Mental State) < 24
- Suicide attempt within 6 months before the start of the study or pre-sent risk of suicide per the investigator's clinical judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Chris Baeken, MD, PhD, +32 2 477 6801, Chris.baeken@uzbrussel.be
Sara De Witte, PhD, sara.dewitte@uzbrussel.be
About this study
Official title: Accelerated dTMS Treatment for ECT-non Responders
This study investigates whether an additional treatment using transcranial magnetic stimulation (TMS) can help severely depressed patients who did not respond well to electroconvulsive therapy (ECT).
All participants will first receive standard ECT treatment for depression, including brain scans (fMRI), psychological testing, clinical assessments, and the collection of blood and stool samples. If the ECT treatment is not effective, patients will be invited to participate in a second part of the study where they receive a 4-day course of accelerated TMS (20 sessions in total).
The study aims to assess whether this additional TMS treatment can reduce depressive symptoms. The study also explores how brain structure, genetics, and gut health may relate to treatment success. In total, 200 patients will be included.
Read the detailed description
Electroconvulsive therapy (ECT) is a well-established and effective treatment for severe major depressive disorder. However, a significant proportion of patients do not achieve remission after ECT, and effective follow-up treatment options for these non-responders remain limited.
This phase IV study explores the clinical effectiveness of an additional course of accelerated deep transcranial magnetic stimulation (dTMS) in patients who show partial or no response to ECT. The accelerated dTMS protocol consists of 20 sessions delivered over four consecutive days.
All patients initially undergo standard ECT treatment, accompanied by comprehensive psychological testing, clinical assessments, functional MRI scans (pre- and post-ECT), and collection of blood and stool samples. These data will be used to evaluate treatment response and investigate biological correlates of treatment outcomes, such as microbiome composition and genetic biomarkers.
Patients who do not reach remission after state-of-the-art ECT will be offered the opportunity to participate in the interventional phase of the study, receiving accelerated dTMS treatment, followed by a third fMRI scan and additional clinical, psychological testing, and biological sampling.
The primary goal is to assess whether this additional dTMS treatment improves remission rates. Secondary goals include evaluating brain-based, genetic, and gut-related predictors of treatment response, with the aim of guiding more personalized treatment strategies in the future.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Major Depressive Disorder, MDD, Electroconvulsive therapy, ECT, Transcranial Magnetic Stimulation, TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS, adTMS
TMS is a non-invasive brain stimulation technique
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | dTMS for depressed patients who did not improve after ECT. Patients will receive a 4-day course of active accelerated dTMS (Brainsway H1 coil; 20 sessions in total). Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Severity - Clinician-Rated
Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17). Treatment response is defined as a ≥50% reduction in HDRS score from baseline. Remission is defined as an HDRS score ≤7.
Measured: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Secondary outcomes (4)
Change in Depression Severity - Self-Reported
Self-reported depressive symptoms measured using the Beck Depression Inventory-II (BDI-II)
Measured: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Change in Suicidal Ideation - Clinician-Rated
Change in suicidal ideation evaluated using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Psychological testing
Working memory task and psychomotor task
Measured: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Neuroimaging
fMRI (functional and structural MRI) + emotion regulation task
Measured: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara De Witte, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115628
- Sponsor's protocol ID
- EC-2024-380
- Other IDs
- Department of psychiatry
- Acronym
- A-TREC
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated dTMS Treatment for ECT-non Responders
- ClinicalTrials.gov ID
- NCT07115628
- Acronym / sponsor ID
- A-TREC / EC-2024-380
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, MDD, Electroconvulsive therapy, ECT, Transcranial Magnetic Stimulation, TMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Aug 2025 (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.
This study investigates whether an additional treatment using transcranial magnetic stimulation (TMS) can help severely depressed patients who did not respond well to electroconvulsive therapy (ECT).
All participants will first receive standard ECT treatment for depression, including brain scans (fMRI), psychological testing, clinical assessments, and the collection of blood and stool samples. If the ECT treatment is not effective, patients will be invited to participate in a second part of the study where they receive a 4-day course of accelerated TMS (20 sessions in total).
The study aims to assess whether this additional TMS treatment can reduce depressive symptoms. The study also explores how brain structure, genetics, and gut health may relate to treatment success. In total, 200 patients will be included.
Detailed description
Electroconvulsive therapy (ECT) is a well-established and effective treatment for severe major depressive disorder. However, a significant proportion of patients do not achieve remission after ECT, and effective follow-up treatment options for these non-responders remain limited.
This phase IV study explores the clinical effectiveness of an additional course of accelerated deep transcranial magnetic stimulation (dTMS) in patients who show partial or no response to ECT. The accelerated dTMS protocol consists of 20 sessions delivered over four consecutive days.
All patients initially undergo standard ECT treatment, accompanied by comprehensive psychological testing, clinical assessments, functional MRI scans (pre- and post-ECT), and collection of blood and stool samples. These data will be used to evaluate treatment response and investigate biological correlates of treatment outcomes, such as microbiome composition and genetic biomarkers.
Patients who do not reach remission after state-of-the-art ECT will be offered the opportunity to participate in the interventional phase of the study, receiving accelerated dTMS treatment, followed by a third fMRI scan and additional clinical, psychological testing, and biological sampling.
The primary goal is to assess whether this additional dTMS treatment improves remission rates. Secondary goals include evaluating brain-based, genetic, and gut-related predictors of treatment response, with the aim of guiding more personalized treatment strategies in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: Transcranial Magnetic StimulationdTMS for depressed patients who did not improve after ECT. Patients will receive a 4-day course of active accelerated dTMS (Brainsway H1 coil; 20 sessions in total). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Major Depressive Disorder (MDD)
- Age between 18 - 70 years
- Referred for ECT treatment
Key exclusion criteria (3 listed)
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, abuse substance, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) except dental fill-ings and the presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with some neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with MRI
- Patients with cognitive disturbances or dementia (Mini Mental State) < 24
- Suicide attempt within 6 months before the start of the study or pre-sent risk of suicide per the investigator's clinical judgment
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMS, adTMSTMS is a non-invasive brain stimulation technique | Device | TMS |
Primary outcome
Change in Depression Severity - Clinician-Rated
Time frame: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17). Treatment response is defined as a ≥50% reduction in HDRS score from baseline. Remission is defined as an HDRS score ≤7.
4 secondary outcomes
Change in Depression Severity - Self-Reported
Time frame: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Change in Suicidal Ideation - Clinician-Rated
Time frame: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Psychological testing
Time frame: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Neuroimaging
Time frame: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Baeken, MD, PhD (+32 2 477 6801, chris.baeken@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Severity - Clinician-Rated (time frame: Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.