Actively Recruiting
Olfactory and Brain Stimulations in Treatment-resistant Depression
Led by Hôpital le Vinatier · Updated on 2025-07-24
80
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
H
Hôpital le Vinatier
Lead Sponsor
F
Fondation de France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olfactory and Brain Stimulations in Treatment-resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of single-episode or recurrent non-psychotic major depressive disorder according to DSM-5 criteria
- Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or higher
- MADRS anhedonia factor score higher than 2
- Stable antidepressant medication for at least 4 weeks before joining
- Ability to speak and read French
- Signed informed consent form before intervention
You will not qualify if you...
- Pre-existing conditions affecting sense of smell, such as congenital anosmia, upper respiratory infection, nasal or sinus disease, brain injury, or nasal surgery
- Neurological diseases
- Other psychiatric disorders or substance abuse except tobacco
- Contraindications to transcranial magnetic stimulation (TMS), such as implanted medical devices or metallic foreign bodies in the head
- Pregnant or breastfeeding women
- Under legal protection or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CH Le Vinatier
Bron, France, 69678
Actively Recruiting
Research Team
S
SARTELET Lydie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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