Status:
COMPLETED
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Federal Ministry of Health, Germany
Institute of Clinical Epidemiology and applied Biometry, University Tuebingen, Germany
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- acute suicidality (MADRS item 10 score \> 4)
- antiepileptic drugs and/or benzodiazepines corresponding to \> 1mg lorazepam / day
- history of brain surgery, significant and clinically relevant brain malformation or neoplasm, head injury, stroke, dementia or other neurodegenerative disorder
- history of seizures
- previous rTMS treatment
- lifetime history of non-response to adequate electroconvulsive therapy (minimum of eight treatments)
- deep brain stimulation
- cardiac pacemakers, intracranial implant, or metal in the cranium
- substance dependence or abuse in the past 3 months (with the exception of tobacco)
- severe somatic comorbidity as judged by the study physician
- pregnancy
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04392947
Start Date
September 29 2020
End Date
July 31 2025
Last Update
September 17 2025
Active Locations (7)
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1
Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg
Augsburg, Germany, 86156
2
University of Leipzig, Dept. Psychiatry and Psychotherapy
Leipzig, Germany
3
University of Munich
Munich, Germany, 80336
4
University of Regensburg, Dept. Psychiatry and Psychotherapy
Regensburg, Germany, 93053