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ACTIVE NOT RECRUITING
NCT05732298
NA

Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

Sponsor: University of Regensburg

View on ClinicalTrials.gov

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.

Official title: Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2023-02-27

Completion Date

2026-03-31

Last Updated

2025-12-01

Healthy Volunteers

No

Conditions

Interventions

DEVICE

intermittend theta burst stimulation (iTBS)

600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday

Locations (1)

Department of Psychiatry and Psychotherapy

Regensburg, Germany