NCT05732311

Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Berthold Langguth, MD, Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	intermittend theta burst stimulation	intermittend theta burst stimulation

Timeline

• Start date: 2023-04-25
• Primary completion: 2026-01-31
• Completion: 2026-02-28
• First posted: 2023-02-17
• Last updated: 2025-12-01

Locations

1 site across 1 country: Germany