Theta Burst Stimulation in Pharmacologically Untreated Patients as Sole Antidepressant Treatment
NCT ID: NCT05732298
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
72 participants
INTERVENTIONAL
2023-02-27
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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active treatment
intermittent theta burst stimulation
intermittend theta burst stimulation (iTBS)
600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday
waiting list
patients waiting for intervention
No interventions assigned to this group
Interventions
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intermittend theta burst stimulation (iTBS)
600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* present episode at least four weeks
* 18-70 years old
* no intake and rejection of anti-depressant medication and
* no adequate anti-depressant medication in the present episode
* no or stable non-drug anti-depressant treatment (e.g. psychotherapy)
* residency in Germany, German speaking
Exclusion Criteria
* relevant neurological or internistic diseases according to study investigator
* participation in other trials during treatment
* pregnancy or breatfeeding
* legal care and placement in a psychiatric hospital
* active suicidality
18 Years
70 Years
ALL
No
Sponsors
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University of Regensburg
OTHER
Responsible Party
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Berthold Langguth, MD, Ph.D.
Prof. Dr.
Principal Investigators
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Berthold Langguth, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
Locations
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Department of Psychiatry and Psychotherapy
Regensburg, , Germany
Countries
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Other Identifiers
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22-3053-101
Identifier Type: -
Identifier Source: org_study_id
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