Major Depression
Conditions
Keywords
Transcranial Magnetic Stimulation, Depression, Theta Burst Stimulation
Brief summary
Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects. This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)
intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* major Depression * informed consent
Exclusion criteria
* seizures in medical history * metallic implants * deep brain stimulation * cardiac pacemaker * brain trauma * psychotic symptoms * substance abuse * pregnancy * Benzodiazepines other than Lorazepam \>1mg/d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%) | after the end of treatment (week 6) |
Secondary
| Measure | Time frame |
|---|---|
| Change of the Hamilton rating scale for depression (HAMD 17) | baseline, after the end of treatment (week 6) |
| Change of the Beck Depression Inventory (BDI) | baseline, after the end of treatment (week 6) |
| Change of the Montgomery-Asberg rating scale for depression (MADRS) score | baseline, after the end of treatment (week 6) |
Countries
Germany
Outcome results
None listed