Major Depressive Disorder (MDD)ERTENCT07727005
Effectiveness of Clustered Versus Tapered Repetitive Transcranial Magnetic Stimulation (rTMS) as Maintenance Therapy Following Successful Acute rTMS Treatment in Patients With Depressive Syndrome
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation in people with Major Depressive Disorder (MDD) and Depressive Episodes, run by Technical University of Munich at 1 site in Germany.
Trial summary
The goal of this clinical trial is to compare two maintenance transcranial magnetic stimulation (rTMS) strategies following successful acute theta burst stimulation (TBS) treatment in adults with depressive syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD), Depressive Episodes, Depressive Syndrome
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2026to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of a depressive syndrome
- Completion of an acute treatment course consisting of 20 sessions of theta burst stimulation (TBS) over 4 weeks
- Response or remission following acute treatment. Response is defined as a ≥50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
- Remission is defined as a MADRS total score ≤10.
- Clinical eligibility for maintenance TBS
- Provision of written informed consent
Who cannot join
- Non-response to acute TBS treatment
- Contraindications to transcranial magnetic stimulation (TMS) or theta burst stimulation (TBS)
- Active substance use disorder (substance use within the past 3 months)
- Acute psychiatric or medical conditions that preclude study participation
- Additional exclusion criteria for the MRI component:
- Contraindications to MRI (e.g., non-MRI-compatible metallic implants or severe claustrophobia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
TUM Universitiy Hospital, Department for Psychiatry and Psychotherapy
Munich, Bavaria, 81675
About this study
Official title: Effectiveness of rTMS as Maintenance Therapy; Clustered rTMS vs. Tapered rTMS
The goal of this clinical trial is to compare two maintenance transcranial magnetic stimulation (rTMS) strategies following successful acute theta burst stimulation (TBS) treatment in adults with depressive syndrome. It will also evaluate whether the two maintenance strategies differ in their ability to maintain the antidepressant treatment response over 24 weeks. The main questions it aims to answer are:
Does clustered maintenance rTMS reduce the risk of depressive relapse or clinically relevant symptom worsening compared with tapered maintenance rTMS? Do the two maintenance strategies differ in depressive symptoms, global clinical status, psychosocial functioning, and MRI-based biomarkers over time?
Read more
Researchers will compare a clustered maintenance rTMS protocol with a tapered maintenance rTMS protocol.
Participants will:
- Complete successful acute TBS treatment before study enrollment
- Be randomly assigned to either clustered or tapered maintenance rTMS
- Receive 20 maintenance stimulation sessions over 20 weeks
- Attend clinical follow-up assessments every 4 weeks for a total follow-up -period of 24 weeks
- Undergo optional multimodal MRI examinations at the Munich study site
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS), including intermittent theta burst stimulation (iTBS), is an established treatment for depressive disorders. While the efficacy of acute treatment has been demonstrated in numerous clinical trials, a substantial proportion of patients experience symptom worsening or relapse following successful acute treatment if no maintenance therapy is provided. Several maintenance strategies have been proposed, including tapered treatment schedules with gradually decreasing treatment frequency and clustered treatment schedules consisting of repeated blocks of consecutive stimulation sessions. However, the available evidence is limited, and no randomized controlled trial has directly compared these two maintenance approaches using identical treatment duration and the same total number of stimulation sessions.
This prospective, randomized, controlled, two-center study aims to compare two maintenance treatment strategies following successful acute iTBS in adults with depressive syndrome. Patients who achieve response or remission after a standardized acute iTBS treatment course will be randomized in a 1:1 ratio to either a tapered maintenance protocol or a clustered maintenance protocol. Randomization will be stratified by study site and baseline depression severity. Because of the different treatment protocols, blinding of participants and treating clinicians is not feasible. MRI data analyses will be performed blinded to treatment allocation.
Both maintenance protocols include 20 stimulation sessions delivered over a 20-week maintenance period following a four-week stimulation-free interval after completion of the acute treatment phase. The treatment protocols differ only in the temporal distribution of maintenance sessions. The tapered protocol gradually reduces treatment frequency over time, whereas the clustered protocol delivers stimulation in four clusters of five consecutive daily sessions.
The primary objective is to compare the time to depressive relapse or clinically relevant symptom worsening during the 24-week follow-up period. Clinically relevant symptom worsening is defined using predefined changes in the Montgomery-Åsberg Depression Rating Scale (MADRS), and relapse is defined as the recurrence of at least moderate depressive symptoms together with loss of the previously achieved treatment response.
Secondary objectives include comparing longitudinal changes in depressive symptom severity, patient-reported depressive symptoms, global clinical status, and psychosocial functioning using the MADRS, Beck Depression Inventory (BDI), Clinical Global Impression (CGI), and Global Assessment of Functioning (GAF), respectively.
An additional objective of the study is to investigate neurobiological correlates of maintenance treatment using multimodal magnetic resonance imaging (MRI). At the Munich study site, participants will be offered optional multimodal MRI examinations. Participation in the MRI component is voluntary and is not required for participation in the clinical trial. MRI assessments include resting-state functional MRI, arterial spin labeling, diffusion imaging including NODDI, and quantitative MRI. These analyses aim to identify imaging biomarkers associated with maintenance of antidepressant effects, symptom worsening, and relapse risk following maintenance iTBS. Participation in the MRI component is optional and is not required for participation in the clinical trial.
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation
- Keywords
- MaintenanceTMS, NIBS, TaperingTMS, ClusterTMS, MDD, DepressiveSyndrome
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst StimulationDevice
Participants receive maintenance rTMS treatment (intermittent theta burst stimulation) following successful acute iTBS treatment. Participants are randomized to either a tapered or a clustered maintenance protocol. Both protocols consist of 20 maintenance stimulation sessions delivered over 20 weeks following a four-week stimulation-free interval but differ in the temporal distribution of stimulation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Tapered Maintenance rTMS TBS | Experimental | Participants receive maintenance theta burst stimulation (TBS) according to a tapered treatment schedule. Following a four-week stimulation-free interval after successful acute TBS, participants receive two sessions per week during weeks 5 to 8 and one session per week during weeks 9 to 20, resulting in a total of 20 maintenance sessions. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation |
| Clustered Maintenance TBS | Experimental | Participants receive maintenance theta burst stimulation (TBS) according to a clustered treatment schedule. Following a four-week stimulation-free interval after successful acute TBS, participants receive four treatment clusters consisting of five sessions per week (1 session per day) during weeks 5, 10, 15, and 20, resulting in a total of 20 maintenance sessions. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to depressive relapse or clinically relevant symptom worsening
Time from randomization to the first occurrence of depressive relapse or clinically relevant symptom worsening during the 24-week follow-up period. Clinically relevant symptom worsening is defined as a transition to a higher depression severity category together with an increase of at least 5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Relapse is defined as recurrence of at least moderate depressive symptoms (MADRS ≥20) together with loss of the previously achieved treatment response.
Measured: From randomization through Week 24
Secondary outcomes (8)
Change in Montgomery-Åsberg Depression Rating Scale Total Score
Change in depressive symptom severity as assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Beck Depression Inventory II Total Score
Change in patient-reported depressive symptom severity as assessed using the Beck Depression Inventory II Scale. Higher total scores indicate greater severity of depressive symptoms.
Measured: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Global Assessment of Functioning Score (GAF)
Change in psychosocial functioning as assessed using the Global Assessment of Functioning scale. Scores range from 0 to 100, with lower scores indicating greater impairment in psychosocial functioning.
Measured: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Clinical Global Impression Score (CGI)
Change in global clinical status as assessed using the Clinical Global Impression scale.
Measured: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Resting-State Functional Connectivity
Change in resting-state functional connectivity derived from functional magnetic resonance imaging.
Measured: During Maintenance rtMS Week 0-24
Change in Cerebral Perfusion Measured by Arterial Spin Labeling
Change in cerebral perfusion parameters derived from arterial spin labeling magnetic resonance imaging.
Measured: During maintenance treatment week 0-24
Change in Diffusion MRI Measures of Structural Connectivity and Microstructure
Change in structural connectivity and tissue microstructure measures derived from diffusion imaging, including neurite orientation dispersion and density imaging.
Measured: during maintenance treatment week 0 to 24
Change in Quantitative MRI Parameters
Change in quantitative magnetic resonance imaging parameters, including T1 mapping, T2 mapping, and magnetization transfer mapping.
Measured: During maintenance treatment week 0-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 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.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants who achieve response or remission following standardized acute theta burst stimulation (TBS) will be randomized in a 1:1 ratio to either a tapered or clustered maintenance TBS protocol. Both groups receive the same total number of maintenance sessions over the same treatment period but differ in the temporal distribution of stimulation sessions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Principal investigator, Ulrike Vogelmann, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727005
- Sponsor's protocol ID
- VISIONS25-MU5
- Other IDs
- 2026-187-S-CT
- Acronym
- ERTE
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of individual participant data has not yet been made.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of rTMS as Maintenance Therapy; Clustered rTMS vs. Tapered rTMS
- ClinicalTrials.gov ID
- NCT07727005
- Acronym / sponsor ID
- ERTE / VISIONS25-MU5
- Keywords
- MaintenanceTMS, NIBS, TaperingTMS, ClusterTMS, MDD, DepressiveSyndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Jul 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 goal of this clinical trial is to compare two maintenance transcranial magnetic stimulation (rTMS) strategies following successful acute theta burst stimulation (TBS) treatment in adults with depressive syndrome. It will also evaluate whether the two maintenance strategies differ in their ability to maintain the antidepressant treatment response over 24 weeks. The main questions it aims to answer are:
Does clustered maintenance rTMS reduce the risk of depressive relapse or clinically relevant symptom worsening compared with tapered maintenance rTMS? Do the two maintenance strategies differ in depressive symptoms, global clinical status, psychosocial functioning, and MRI-based biomarkers over time?
Researchers will compare a clustered maintenance rTMS protocol with a tapered maintenance rTMS protocol.
Participants will:
- Complete successful acute TBS treatment before study enrollment
- Be randomly assigned to either clustered or tapered maintenance rTMS
- Receive 20 maintenance stimulation sessions over 20 weeks
- Attend clinical follow-up assessments every 4 weeks for a total follow-up -period of 24 weeks
- Undergo optional multimodal MRI examinations at the Munich study site
Detailed description
Repetitive transcranial magnetic stimulation (rTMS), including intermittent theta burst stimulation (iTBS), is an established treatment for depressive disorders. While the efficacy of acute treatment has been demonstrated in numerous clinical trials, a substantial proportion of patients experience symptom worsening or relapse following successful acute treatment if no maintenance therapy is provided. Several maintenance strategies have been proposed, including tapered treatment schedules with gradually decreasing treatment frequency and clustered treatment schedules consisting of repeated blocks of consecutive stimulation sessions. However, the available evidence is limited, and no randomized controlled trial has directly compared these two maintenance approaches using identical treatment duration and the same total number of stimulation sessions.
This prospective, randomized, controlled, two-center study aims to compare two maintenance treatment strategies following successful acute iTBS in adults with depressive syndrome. Patients who achieve response or remission after a standardized acute iTBS treatment course will be randomized in a 1:1 ratio to either a tapered maintenance protocol or a clustered maintenance protocol. Randomization will be stratified by study site and baseline depression severity. Because of the different treatment protocols, blinding of participants and treating clinicians is not feasible. MRI data analyses will be performed blinded to treatment allocation.
Both maintenance protocols include 20 stimulation sessions delivered over a 20-week maintenance period following a four-week stimulation-free interval after completion of the acute treatment phase. The treatment protocols differ only in the temporal distribution of maintenance sessions. The tapered protocol gradually reduces treatment frequency over time, whereas the clustered protocol delivers stimulation in four clusters of five consecutive daily sessions.
The primary objective is to compare the time to depressive relapse or clinically relevant symptom worsening during the 24-week follow-up period. Clinically relevant symptom worsening is defined using predefined changes in the Montgomery-Åsberg Depression Rating Scale (MADRS), and relapse is defined as the recurrence of at least moderate depressive symptoms together with loss of the previously achieved treatment response.
Secondary objectives include comparing longitudinal changes in depressive symptom severity, patient-reported depressive symptoms, global clinical status, and psychosocial functioning using the MADRS, Beck Depression Inventory (BDI), Clinical Global Impression (CGI), and Global Assessment of Functioning (GAF), respectively.
An additional objective of the study is to investigate neurobiological correlates of maintenance treatment using multimodal magnetic resonance imaging (MRI). At the Munich study site, participants will be offered optional multimodal MRI examinations. Participation in the MRI component is voluntary and is not required for participation in the clinical trial. MRI assessments include resting-state functional MRI, arterial spin labeling, diffusion imaging including NODDI, and quantitative MRI. These analyses aim to identify imaging biomarkers associated with maintenance of antidepressant effects, symptom worsening, and relapse risk following maintenance iTBS. Participation in the MRI component is optional and is not required for participation in the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants who achieve response or remission following standardized acute theta burst stimulation (TBS) will be randomized in a 1:1 ratio to either a tapered or clustered maintenance TBS protocol. Both groups receive the same total number of maintenance sessions over the same treatment period but differ in the temporal distribution of stimulation sessions
| Arm | Type | Receives |
|---|---|---|
| Tapered Maintenance rTMS TBS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst StimulationParticipants receive maintenance theta burst stimulation (TBS) according to a tapered treatment schedule. Following a four-week stimulation-free interval after successful acute TBS, participants receive two sessions per week during weeks 5 to 8 and one session per week during weeks 9 to 20, resulting in a total of 20 maintenance sessions. |
| Clustered Maintenance TBS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst StimulationParticipants receive maintenance theta burst stimulation (TBS) according to a clustered treatment schedule. Following a four-week stimulation-free interval after successful acute TBS, participants receive four treatment clusters consisting of five sessions per week (1 session per day) during weeks 5, 10, 15, and 20, resulting in a total of 20 maintenance sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Diagnosis of a depressive syndrome
- Completion of an acute treatment course consisting of 20 sessions of theta burst stimulation (TBS) over 4 weeks
- Response or remission following acute treatment. Response is defined as a ≥50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
- Remission is defined as a MADRS total score ≤10.
Key exclusion criteria (6 listed)
- Non-response to acute TBS treatment
- Contraindications to transcranial magnetic stimulation (TMS) or theta burst stimulation (TBS)
- Active substance use disorder (substance use within the past 3 months)
- Acute psychiatric or medical conditions that preclude study participation
- Contraindications to MRI (e.g., non-MRI-compatible metallic implants or severe claustrophobia)
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst StimulationParticipants receive maintenance rTMS treatment (intermittent theta burst stimulation) following successful acute iTBS treatment. Participants are randomized to either a tapered or a clustered maintenance protocol. Both protocols consist of 20 maintenance stimulation sessions delivered over 20 weeks following a four-week stimulation-free interval but differ in the temporal distribution of stimulation sessions. | Device | Clustered Maintenance TBS, Tapered Maintenance rTMS TBS |
Primary outcome
Time to depressive relapse or clinically relevant symptom worsening
Time frame: From randomization through Week 24
Time from randomization to the first occurrence of depressive relapse or clinically relevant symptom worsening during the 24-week follow-up period. Clinically relevant symptom worsening is defined as a transition to a higher depression severity category together with an increase of at least 5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Relapse is defined as recurrence of at least moderate depressive symptoms (MADRS ≥20) together with loss of the previously achieved treatment response.
8 secondary outcomes
Change in Montgomery-Åsberg Depression Rating Scale Total Score
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Beck Depression Inventory II Total Score
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Global Assessment of Functioning Score (GAF)
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Clinical Global Impression Score (CGI)
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Change in Resting-State Functional Connectivity
Time frame: During Maintenance rtMS Week 0-24
Change in Cerebral Perfusion Measured by Arterial Spin Labeling
Time frame: During maintenance treatment week 0-24
Change in Diffusion MRI Measures of Structural Connectivity and Microstructure
Time frame: during maintenance treatment week 0 to 24
Change in Quantitative MRI Parameters
Time frame: During maintenance treatment week 0-24
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data has not yet been made.
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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 Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation in people with Major Depressive Disorder (MDD) and Depressive Episodes, run by Technical University of Munich at 1 site in Germany.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Jul 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 Germany. 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 Ulrike Vogelmann, Senior physician (089/4140-6882, ulrike.vogelmann@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to depressive relapse or clinically relevant symptom worsening (time frame: From randomization through Week 24). 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 27 Jul 2026.