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Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment

NCT05732298 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-01

No results posted yet for this study

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

Interventions

DEVICE

intermittend theta burst stimulation (iTBS)

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

Sponsors & Collaborators

  • University of Regensburg

    lead OTHER

Principal Investigators

  • Berthold Langguth, Prof. · University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732298 on ClinicalTrials.gov