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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
Sponsor: Technical University of Munich
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
Official title: Effectiveness of rTMS as Maintenance Therapy; Clustered rTMS vs. Tapered rTMS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-08-01
Completion Date
2028-09-30
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
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.
Locations (1)
TUM Universitiy Hospital, Department for Psychiatry and Psychotherapy
Munich, Bavaria, Germany