NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07727005

Not Yet RecruitingNA

Sponsor: Technical University of Munich

Conditions: Major Depressive Disorder (MDD), Depressive Episodes, Depressive Syndrome

Interventions: Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* Remission is defined as a MADRS total score ≤10.
* Clinical eligibility for maintenance TBS
* Provision of written informed consent

Exclusion Criteria:

* 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

Additional exclusion criteria for the MRI component:

\- Contraindications to MRI (e.g., non-MRI-compatible metallic implants or severe claustrophobia)

Locations (1)

Munich, Bavaria, Germany