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
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
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
Parallel
Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation
DeviceParticipants 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.
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.
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.
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.
Change in Clinical Global Impression Score (CGI)
Change in global clinical status as assessed using the Clinical Global Impression scale.
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Technical University of Munich
Lead sponsor
Medizinische Universitätsklinik Tübingen
Collaborator
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