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Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation

NCT04392947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2025-09-17

No results posted yet for this study

Summary

This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.

Conditions

Interventions

DEVICE

Transcranial Magnetic Stimulation

MagVenture Coil Cool B70 A/P

DEVICE

Sham Transcranial Magnetic Stimulation

MagVenture Coil Cool B70 A/P without TMS being actively delivered

Sponsors & Collaborators

  • Federal Ministry of Health, Germany

    collaborator OTHER_GOV

  • Institute of Clinical Epidemiology and applied Biometry, University Tuebingen, Germany

    collaborator UNKNOWN

  • Center of Clinical Trials, University Tuebingen, Germany

    collaborator UNKNOWN

  • University of Ulm

    collaborator OTHER

  • Department of Psychiatry and Psychotherapy, University Regensburg, Germany

    collaborator UNKNOWN

  • Department of Psychiatry and Psychotherapy, University Wuerzburg, Germany

    collaborator UNKNOWN

  • Department of Psychiatry and Psychotherapy, University Munich (LMU), Germany

    collaborator UNKNOWN

  • Department of Psychiatry and Psychotherapy, University Leipzig, Germany

    collaborator UNKNOWN

  • Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Germany

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Christian Plewnia, Prof., MD · Department of Psychiatry and Psychotherapy, University of Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2025-05-28
Completion
2025-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392947 on ClinicalTrials.gov