Olfactory and Brain Stimulations in Treatment-resistant Depression (COBRA)
Treatment-resistant Depression
About this trial
This is an interventional treatment trial for Treatment-resistant Depression focused on measuring Depression, brain stimulation, anhedonia, odor
Eligibility Criteria
Inclusion Criteria: had a primary diagnosis of single-episode or recurrent non-psychotic major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria; scored 20 or over on the MADRS (Montgomery-Åsberg Depression Rating Scale) (Montgomery and Åsberg, 1979) and scored higher than 2 on the MADRS item 8 anhedonia factor score; a stable antidepressant medication for 4 weeks prior to inclusion; be able to speak and read French; sign a consent form before intervention. Exclusion Criteria: a pre-existing condition that affects olfaction including congenital anosmia, upper respiratory tract infection, nasal and/or sinus disease, brain injury or nasal surgery; a neurological disease; other comorbid psychiatric disorders or substance abuse (except tobacco); contraindications to TMS (medical devices implanted or metallic foreign body in the head); pregnant or lactating mothers (controlled by urine pregnancy tests); measure of protection or guardianship of justice.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
iTBS active combined with an olfactory stimulation
iTBS active alone
Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.
Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.