NCT04392947Completed
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
This is a randomized, double-blind, sham-controlled multicenter clinical trial. The aim is to provide evidence for efficacy of TBS in the treatment of patients with major depression. There will be a direct comparison between combined cTBS/iTBS with sham TBS. Overall, 236 patients with major depression will be randomized either to active TBS or sham TBS in a 1:1 ratio. The planned stimulation paradigms will be applied as add-on therapy to standard therapy (antidepressive medication and / or psychotherapy). Patients will receive 30 stimulation sessions in a 6-week treatment period (one session daily from Monday to Friday). Follow up assessments are scheduled 1 and 3 months after end of treatment period.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 238 (actual)
- First submitted
- 8 May 2020
- Start date
- 29 Sept 2020
- Primary completion date
- 28 May 2025
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Depression
- NCT number
- NCT04392947
What you commit to
- Study type: Interventional
- Participants enrolled: 238
- From 29 Sept 2020 to the primary completion date, 28 May 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- antiepileptic drugs and/or benzodiazepines corresponding to \> 1mg lorazepam / day
- previous rTMS treatment
Other illness
- history of brain surgery, significant and clinically relevant brain malformation or neoplasm, head injury, stroke, dementia or other neurodegenerative disorder
- history of seizures
- lifetime history of non-response to adequate electroconvulsive therapy (minimum of eight treatments)
- cardiac pacemakers, intracranial implant, or metal in the cranium
Other
- acute suicidality (MADRS item 10 score \> 4)
- deep brain stimulation
- substance dependence or abuse in the past 3 months (with the exception of tobacco)
- severe somatic comorbidity as judged by the study physician
- pregnancy
Who the study is looking for
- moderate or severe unipolar depression diagnosed according to criteria of Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
- duration of the current episode must be ≥ 6 weeks and ≤ 2 years
- HDRS17 ≥ 18
- mild to moderate treatment resistance according to the Antidepressant Treatment History Form \[ATHF-SF\]. Treatment resistance is defined as having failed at least one but no more than three adequate antidepressant treatments in this episode
- stable antidepressive medication 4 weeks before treatment or no antidepressive treatment
- no further relevant psychiatric axis-I and/or axis-II disorder except for anxiety disorders (according to DSM-5 and SCID-5-PD)
- no comorbid psychotic symptoms
- ability to give consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| University of Leipzig, Dept. Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| University of Munich Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| University of Regensburg, Dept. Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| University of Tuebingen, Dept Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| University of Um, Dept. Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
| University of Wuerzburg, Dept. Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.