An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation in Major Depressive Disorder (MDD), Depressive Episodes and Depressive Syndrome, sponsored by Technical University of Munich. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
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:
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 100 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional exclusion criteria for the MRI component:
- Contraindications to MRI (e.g., non-MRI-compatible metallic implants or severe claustrophobia)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation
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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation
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.
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.
Time frame: From randomization through Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During maintenance treatment week 0-24
Plan to share: Undecided — A decision regarding the sharing of individual participant data has not yet been made.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2028, 25 months later.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 25 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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