Major Depressive Disorder (MDD)RMTSECT2NCT07324070
Electroconvulsive Therapy Augmented With Transcranial Magnetic Stimulation for Treatment Resistant Depression
A study testing Electroconvulsive therapy and Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD) and Treatment Resistant Depression (TRD), run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The RTMSECT2 study was design to compare the application of electroconvulsive therapy augmented by transcranial magnetic stimulation. Subject will be compared both within groups and in group using psychometric scales and different deliver energy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
- What is being tested?
- Electroconvulsive therapy and Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Jan 2026to 5 Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to 18 or higher
- MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20
- Major depressive disorder according to ICD 10
Who cannot join
- Other axis 1 disorder (for example schizofrenia, addiction, etc.)
- No dementia
- ECT in the last 3 months
- TMS in the last 3 months
- Psychotic disease or symptoms
- Ppregnancy or lactation
Show all 9Show fewer
- Any neurological disease (for example epilepsy, etc.)
- Participation in another clinical trial within the last 30 days
- somatic condition which contraindicates ECT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital, Psychiatry department
Prague, Czech, 120 39
Daniel Divacky, + 420 224 965 357, daniel.divacky@lf1.cuni.cz
About this study
Official title: New Methods Electroconvulsive Therapy Augmentation
The RTMSECT2 study was design to compare the application of electroconvulsive therapy augmented by transcranial magnetic stimulation. Subject will be compared both within groups and in group using psychometric scales and different deliver energy
Read the detailed description
The study is monocentric, sham - controlled, randomized and triple blind (subjects, ECT and TMS practitioners, psychological assessment and outcome assessor). Subjects are randomized into two arms.
The primary objective is to determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold. iTBS is administered with the shortest possible latency before the ECT procedure itself, ideally within two minutes of iTBS completion. The target site is the left DLPFC. The ECT dose is determined via a titration method to identify the lowest energy level required to elicit an epileptic seizure (seizure threshold). From the second session onwards, a stimulus intensity of 6 times the seizure threshold (6xST) is applied.
Delivered energy is measured in percentage for TMS and ECT of the maximum charge that the devices are able to administer. In the event of inadequate seizure duration, the dose will be increased by 100% at the subsequent session.
Primary outcome of the study is the overall apllied dose. Then Time to Recovery (TTR) is measured in minutes until fully awake. The subjects will be closely monitored throughout the entire ECT courses including psychometric scales.
The MECTA SIGMA device will be used for ECT. The Deymed DuoMAG XT will be used for TMS/iTBS.
- Being tested
- Electroconvulsive therapy, Transcranial Magnetic Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapyDevice
transcranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy
Transcranial Magnetic StimulationDevice
Transcranial magnetic stimulation, intermitent theta burst stimulation or sham TMS
| Study group | Role | What they receive |
|---|---|---|
| Blue group | Experimental | active group Receives: Device: Electroconvulsive therapy; Device: Transcranial Magnetic Stimulation |
| Red group | Sham comparator | Not described Receives: Device: Electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of the seizure treshold of ECT
determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold
Measured: during each ECT procedure
Secondary outcomes (10)
Time to Recovery (TTR)
The duration from ECT administration to the restoration of full consciousness, will be measured in minutes and assessed using a modified Glasgow Coma Scale.
Measured: immediately after each ECT procedure
speed of onset of antidepressant effect
according to MADRS
Measured: T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4)
MADRS response rate to treatment
Percentage of participants experiencing a 50% decrease in MADRS
Measured: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
MADRS total response
change in total MADRS score
Measured: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
AMI - SF (Autobiographical Memory Interview - short form)
This scale is intended to quantify retrograde amnesia following electroconvulsive therapy (ECT).
Measured: T1: baseline, T3: after the course of ECT, within 2 days
QIDS (The Quick Inventory of Depressive Symptomatology)
scale for self - assessment of depressive symptoms
Measured: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
ECCA (Electroconvulsive cognitive assesment)
cognitive scale optimized for patients undergoing ECT
Measured: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
MoCA (Montreal Cognitive Assessment)
screening test for cognitive functions, one of inclusion criteria of the study
Measured: T1: baseline, T3: after the course of ECT, within 2 days
TMT (trail making test)
psychometric test for evaluation of cisual-perceptual and executive functions
Measured: T1: baseline, T3: after the course of ECT, within 2 days
RAVLT (The Rey Auditory Verbal Learning Test)
Neuropsychological assessment designed to evaluate verbal memory in patients
Measured: T1: baseline, T3: after the course of ECT, within 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start5 Jan 2026
- Primary completion5 Jan 2028 (estimated)
- Study completion5 Jan 2029 (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
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Divácký, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324070
- Sponsor's protocol ID
- 102/25 S-IV Grant AP
- Acronym
- RMTSECT2
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data can be shared when requested from a verified researcher
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Methods Electroconvulsive Therapy Augmentation
- ClinicalTrials.gov ID
- NCT07324070
- Acronym / sponsor ID
- RMTSECT2 / 102/25 S-IV Grant AP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jan 2028 (estimated)
- Study completion
- 5 Jan 2029 (estimated)
- First posted
- 7 Jan 2026 (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 RTMSECT2 study was design to compare the application of electroconvulsive therapy augmented by transcranial magnetic stimulation. Subject will be compared both within groups and in group using psychometric scales and different deliver energy
Detailed description
The study is monocentric, sham - controlled, randomized and triple blind (subjects, ECT and TMS practitioners, psychological assessment and outcome assessor). Subjects are randomized into two arms.
The primary objective is to determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold. iTBS is administered with the shortest possible latency before the ECT procedure itself, ideally within two minutes of iTBS completion. The target site is the left DLPFC. The ECT dose is determined via a titration method to identify the lowest energy level required to elicit an epileptic seizure (seizure threshold). From the second session onwards, a stimulus intensity of 6 times the seizure threshold (6xST) is applied.
Delivered energy is measured in percentage for TMS and ECT of the maximum charge that the devices are able to administer. In the event of inadequate seizure duration, the dose will be increased by 100% at the subsequent session.
Primary outcome of the study is the overall apllied dose. Then Time to Recovery (TTR) is measured in minutes until fully awake. The subjects will be closely monitored throughout the entire ECT courses including psychometric scales.
The MECTA SIGMA device will be used for ECT. The Deymed DuoMAG XT will be used for TMS/iTBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue group | Experimental | Device: Electroconvulsive therapy, Device: Transcranial Magnetic Stimulationactive group |
| Red group | Sham comparator | Device: Electroconvulsive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal to 18 or higher
- MADRS (Montgomery-Asberg Depression Scale) qual or higher than 20
- Major depressive disorder according to ICD 10
Key exclusion criteria (9 listed)
- Other axis 1 disorder (for example schizofrenia, addiction, etc.)
- No dementia
- ECT in the last 3 months
- TMS in the last 3 months
- Psychotic disease or symptoms
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 therapytranscranial magnetic stimulation in intermitent theta burst stimulation protocol plus electroconvulsive therapy | Device | Blue group, Red group |
| Transcranial Magnetic StimulationTranscranial magnetic stimulation, intermitent theta burst stimulation or sham TMS | Device | Blue group |
Primary outcome
reduction of the seizure treshold of ECT
Time frame: during each ECT procedure
determine whether TMS priming using the iTBS protocol prior to ECT results in a reduction of the seizure threshold
10 secondary outcomes
Time to Recovery (TTR)
Time frame: immediately after each ECT procedure
speed of onset of antidepressant effect
Time frame: T1: baseline and T2: during the course of ECT, between second and third ECT application (day 4)
MADRS response rate to treatment
Time frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
MADRS total response
Time frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
AMI - SF (Autobiographical Memory Interview - short form)
Time frame: T1: baseline, T3: after the course of ECT, within 2 days
QIDS (The Quick Inventory of Depressive Symptomatology)
Time frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
ECCA (Electroconvulsive cognitive assesment)
Time frame: T1: baseline, T2: during the course of ECT, between second and third ECT application (day 4), T3: after the course of ECT, within 2 days
MoCA (Montreal Cognitive Assessment)
Time frame: T1: baseline, T3: after the course of ECT, within 2 days
TMT (trail making test)
Time frame: T1: baseline, T3: after the course of ECT, within 2 days
RAVLT (The Rey Auditory Verbal Learning Test)
Time frame: T1: baseline, T3: after the course of ECT, within 2 days
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 7 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data can be shared when requested from a verified researcher
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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 Electroconvulsive therapy and Transcranial Magnetic Stimulation in people with Major Depressive Disorder (MDD) and Treatment Resistant Depression (TRD), run by Charles University, Czech Republic at 1 site in Czechia.
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 9 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 7 Jan 2026. 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 Czechia. 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. Some participants in this study may receive a placebo. 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 Daniel Divacky (+420 224 965 357, daniel.divacky@lf1.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of the seizure treshold of ECT (time frame: during each ECT procedure). 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 7 Jan 2026.