Stepped Care aiTBS 2 Depression Study (Ghent) (aiTBS2-Ghent)
Depressive Disorder, Major, Treatment Resistant Depression, Melancholia
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major depressive disorder, Treatment resistant depression, Accelerated intermittent thetaburst stimulation, Cognitive control training, Neuroimaging
Eligibility Criteria
Inclusion Criteria:
- Antidepressant-free unipolar major depression with melancholic features
- Not responding to at least two trials with an antidepressant
- Aged between 18-65 years old
Exclusion Criteria:
- Depression with bipolar/psychotic features
- Dysthymia
- Severe personality disorders
- Active substance abuse/dependence within a year prior to inclusion
- Pregnancy or without effective anticonception for the duration of the trial
- ECT non-responder
- No response to more than 9 antidepressants
- Any neurological condition
- Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
- Any implanted metal device in the head region
- Current or past history of epilepsy
- Neurosurgical interventions
- Known allergic reaction to radiotracers or associated compounds
Healthy volunteers may be accepted as control subjects.
Sites / Locations
- University Hospital GhentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Active aiTBS - active CCT+SSRI
Active aiTBS - sham CCT+SSRI
Sham aiTBS - aiTBS - active CCT+SSRI
Sham aiTBS - aiTBS - sham CCT+SSRI
Patients receive active aiTBS treatment in the first week, and starting from week 3 receive active CCT for a period of 4 weeks in combination with an antidepressant (SSRI)
Patients receive active aiTBS treatment in the first week, and starting from week 3 receive a control training for a period of 4 weeks in combination with an antidepressant (SSRI)
Patients receive sham aiTBS treatment in the first week, real aiTBS treatment in the third week, and starting from the fifth week receive CCT for a period of 4 weeks in combination with an antidepressant (SSRI)
Patients receive sham aiTBS treatment in the first week, real aiTBS treatment in the third week, and starting from the fifth week control training for a period of 4 weeks in combination with an antidepressant (SSRI)