Tests brain stimulation with pleasant odors for treatment-resistant depression
Compares brain stimulation alone with brain stimulation plus pleasant odors in adults with depression.
Plain-language title generated from the registry record
Registry title: Olfactory and Brain Stimulations in Treatment-resistant Depression
Key facts
- Where
- Bron, FranceSee the site
Where in France
- CH Le VinatierBron, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hôpital le Vinatier
- Trial code
- NCT05661383
- Record updated
- 24 July 2025
- Original description
This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with major depressive disorder (MDD) following two types of intervention: iTBS active alone or iTBS active combined with olfactory stimulations.Read full original descriptionShow less
Combining Hedonic Olfactory and BRAin Stimulations in Treatment-resistant Depression
This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with major depressive disorder (MDD) following two types of intervention: iTBS active alone or iTBS active combined with olfactory stimulations.
Inclusion: 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: 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.