NCT04392947

Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Major Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-29
• Primary completion: 2025-05-28
• Completion: 2025-07-31
• First posted: 2020-05-19
• Last updated: 2025-09-17

Locations

7 sites across 1 country: Germany