NCT05732298

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS). This is a wait-list control study, and the arms differ in the start of the four-week treatment (either promptly i.e., at the beginning of the next week of work) or delayed (start of treatment in four weeks). The patients to be treated are those who refuse treatment with antidepressant medications. The effectiveness of the four-week iTBS treatment is to be evaluated in comparison to a "watchful waiting" after 4 weeks. A interim analysis is planned after 36 patients.

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	intermittend theta burst stimulation (iTBS)	600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday

Timeline

• Start date: 2023-02-27
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2023-02-17
• Last updated: 2025-12-01

Locations

1 site across 1 country: Germany