Interventional Recruiting
NCT05732311 on ClinicalTrials.gov
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
- Sponsor: Edna Pasher Ph.D & Associates (Israel)
- Enrollment: 60 (Estimated)
- Study start: 2023-04-25 (Actual)
- Primary completion: 2026-01-31 (Estimated)
- Study completion: 2026-02-28 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.
Conditions
- Depression
Intervention / Treatment
- Device: intermittend theta burst stimulation
Primary Outcome Measures
-
relapse (number of patients who have a relapse for depression)
(33 weeks)
50% increase of symptoms according to Hamilton depression rating scale
Countries
Germany
Locations and Investigators
- Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany (Recruiting)