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Effectiveness of Clustered Versus Tapered Repetitive Transcranial Magnetic Stimulation (rTMS) as Maintenance Therapy Following Successful Acute rTMS Treatment in Patients With Depressive Syndrome

NCT07727005 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-27

No results posted yet for this study

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

Conditions

  • Major Depressive Disorder (MDD)
  • Depressive Episodes
  • Depressive Syndrome

Interventions

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.

Sponsors & Collaborators

  • Medizinische Universitätsklinik Tübingen

    collaborator UNKNOWN

  • Technical University of Munich

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727005 on ClinicalTrials.gov