Effectiveness of Clustered Versus Tapered Repetitive Transcranial Magnetic Stimulation (rTMS) as … (NCT07727005) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Clustered Versus Tapered Repetitive Transcranial Magnetic Stimulation (rTMS) as Maintenance Therapy Following Successful Acute rTMS Treatment in Patients With Depressive Syndrome
Germany100 participantsStarted 2026-08-01
Plain-language 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. 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to depressive relapse or clinically relevant symptom worsening