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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Eligibility

Primary outcome measure(s)

• Time to depressive relapse or clinically relevant symptom worsening — 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.

Trial sites (1)

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