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Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Department of Psychiatry and Psychotherapy
Regensburg, Germany
Start Date
February 27, 2023
Primary Completion Date
December 31, 2025
Completion Date
March 31, 2026
Last Updated
December 1, 2025
72
ESTIMATED participants
intermittend theta burst stimulation (iTBS)
DEVICE
Lead Sponsor
University of Regensburg
NCT07360600
NCT06793397
Data Source & Attribution
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