Actively Recruiting
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Led by Berthold Langguth, MD, Ph.D. · Updated on 2025-12-01
60
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
- Moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 >16 points)
- Response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment <11 points)
- No concomitant psychotic symptoms
- No other relevant psychiatric disorder as assessed by the study physician
- Residence in Germany and German speaking that allows understanding of the information provided
- Patient is capable of giving consent
You will not qualify if you...
- Fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps)
- Severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
- Current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
- Acute suicidality
- Pregnancy
- Current participation in another study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, Germany, 93055
Actively Recruiting
Research Team
M
Martin Schecklmann, Prof.
CONTACT
M
Mohamed Abdelnaim, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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