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 Recruiting

• 2 other identifiers: VISIONS25-MU52026-187-S-CT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Depressive Episodes; Depressive Syndrome; Major Depressive Disorder (MDD)

Keywords

MaintenanceTMS; NIBS; TaperingTMS; ClusterTMS; MDD; DepressiveSyndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization through Week 24

Secondary Outcomes (8)

• Change in Montgomery-Åsberg Depression Rating Scale Total Score

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

• Change in Beck Depression Inventory II Total Score

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

• Change in Global Assessment of Functioning Score (GAF)

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

• Change in Clinical Global Impression Score (CGI)

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

• Change in Resting-State Functional Connectivity

  During Maintenance rtMS Week 0-24

Study Arms (2)

Tapered Maintenance rTMS TBS

EXPERIMENTAL

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.

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

Clustered Maintenance TBS

EXPERIMENTAL

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.

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

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS), Theta Burst Stimulation DEVICE

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.

Clustered Maintenance TBS; Tapered Maintenance rTMS TBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead
• Medizinische Universitätsklinik Tübingen: collaborator

Study Sites (1)

TUM Universitiy Hospital, Department for Psychiatry and Psychotherapy

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Ulrike Vogelmann, Senior physician

CONTACT

089/4140-6882; ulrike.vogelmann@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: MRI data analyses will be performed blinded to treatment allocation. Participants and treating clinicians are not blinded because of the different treatment protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Privatdozentin, Senior Physician, Department of Psychiatry and Psychotherapy

Model Details: Participants who achieve response or remission following standardized acute theta burst stimulation (TBS) will be randomized in a 1:1 ratio to either a tapered or clustered maintenance TBS protocol. Both groups receive the same total number of maintenance sessions over the same treatment period but differ in the temporal distribution of stimulation sessions

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Locations

DE (1)