Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation (TBS-D)
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depression, theta burst stimulation, dorsolateral prefrontal cortex, randomized, sham-controlled, multicenter
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Leipzig, Dept. Psychiatry and PsychotherapyRecruiting
- University of MunichRecruiting
- University of Regensburg, Dept. Psychiatry and PsychotherapyRecruiting
- University of Tuebingen, Dept Psychiatry and PsychotherapyRecruiting
- University of Um, Dept. Psychiatry and PsychotherapyRecruiting
- University of Wuerzburg, Dept. Psychiatry and PsychotherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
combined iTBS/cTBS
sham stimulation
Combined theta burst stimulation (TBS) of the left (intermittent TBS, iTBS) and right (continuous TBS, cTBS) dorsolateral prefrontal cortex (dlPFC; F3 and F4 according to EEG10/20 system). Each stimulation session will comprise 2 trains of 600 stimuli each applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s. In the same session, stimulation with cTBS will be applied continuously for 40 s. Intensity of iTBS/cTBS will be standardized at 80 % of the resting motor threshold (rMT). Additionally, patients receive an electrical co-stimulation of the forehead. One electrode is fixed to FZ and the 2nd one is either fixed to the left forehead (iTBS) or the right forehead (cTBS), rectangular aligned to the upper edge of the FZ-electrode with a distance of 0.5 cm. Intensity of the co-stimulation is applied with 50% of TBS-intensity.
Setup is identical to combined active iTBS/cTBS but TBS is not actively delivered