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:
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for the MRI component:
- Contraindications to MRI (e.g., non-MRI-compatible metallic implants or severe claustrophobia)
ulrike.vogelmann@mri.tum.de
MRI data analyses will be performed blinded to treatment allocation. Participants and treating clinicians are not blinded because of the different treatment protocols.
Participants receive maintenance theta burst stimulation (TBS) according to a tapered treatment schedule. Following a four-week stimulation-free interval after successful acute TBS, participants receive two sessions per week during weeks 5 to 8 and one session per week during weeks 9 to 20, resulting in a total of 20 maintenance sessions.
Participants receive maintenance theta burst stimulation (TBS) according to a clustered treatment schedule. Following a four-week stimulation-free interval after successful acute TBS, participants receive four treatment clusters consisting of five sessions per week (1 session per day) during weeks 5, 10, 15, and 20, resulting in a total of 20 maintenance sessions.
Maintenance rTMS for Depression (Maitr-De)
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Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression
Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?
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Maintenance TMS in Treatment Resistant Depression
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Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder