This is a randomized, controlled trial in which 72 patients with depressive disorder were treated in two study arms using the non-invasive brain stimulation method of intermittent thetaburst intermittent theta burst stimulation (iTBS). 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
600 pulses of iTBS per day with 120% resting motor threshold applied four weeks at Monday-Friday
Department of Psychiatry and Psychotherapy
Regensburg, Germany
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Time frame: 8 weeks
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (range: 0-65; higher values = worse outcome)
Time frame: 20 weeks
Major Depression Inventory
Major Depression Inventory (range: 0-50; higher values = worse outcome)
Time frame: 20 weeks
World Health Organisation quality of life bref
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Time frame: 20 weeks
State Trait Anxiety Inventory
State Trait Anxiety Inventory (range: 20-80 for both trait and state anxiety (two scales); higher values = worse outcome)
Time frame: 20 weeks
clinical global impression
clinical global impression (range: 0-7; higher values = worse outcome)
Time frame: 20 weeks
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