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
Technical University of Munich
Lead sponsor
Medizinische Universitätsklinik Tübingen
Collaborator