Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression

Study Overview
=================
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.

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral theta burst stimulation to the DLPFC<br>intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC | Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)<br>* 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)<br>|
| Placebo Comparator: Sham stimulation<br>Sham stimulation with a 45° tilted coil | Device: Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Magnetic Stimulation, Depression, Theta Burst Stimulation