Combining pleasant Olfactory and BRAin stimulations in treatment-resistant depression (COBRA): study protocol for a randomized controlled trial.
Laetitia Imbert, Cécilia Neige, Maylis Dumas...
https://pubmed.ncbi.nlm.nih.gov/39744036Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05661383
Combining Hedonic Olfactory and Brain Stimulations in Treatment-resistant Depression
Led by Hôpital le Vinatier · Updated on 2025-07-24
80
Participants Needed
1
Research Sites
35 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
Major depressive disorder (MDD) is a common psychiatric condition affecting about 5% of adults worldwide. This research compares two interventions for treatment-resistant depression: intermittent theta-burst stimulation (iTBS) alone, and iTBS combined with pleasant olfactory stimulations. The study aims to see if adding olfactory training enhances the benefits of brain stimulation by improving symptoms like anhedonia, which is the loss of pleasure.
CONDITIONS
Brief Title
Olfactory and Brain Stimulations in Treatment-resistant Depression
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Primary diagnosis of single-episode or recurrent non-psychotic major depressive disorder according to DSM-5
- Montgomery-�sberg Depression Rating Scale (MADRS) score of 20 or higher and MADRS anhedonia item score above 2
- Stable antidepressant medication for at least 4 weeks before inclusion
- Ability to speak and read French
- Signed informed consent before intervention
You will not qualify if you...
- Any condition affecting sense of smell, including congenital anosmia, upper respiratory tract 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
- Pregnancy or breastfeeding
- Under legal protection measures or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 days
Participants receive intermittent theta-burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex, with or without simultaneous pleasant odor exposure, administered as 50 sessions over 10 days.
5 sessions per working day, 1 hour apart
Follow-up
Duration - 3 months
Participants are assessed for changes in depressive symptoms and other outcomes immediately after treatment and at 1 and 3 months post-treatment.
3 follow-up visits (immediately post-treatment, 1 month, and 3 months after treatment)
Trial Site Locations
Total: 1 location
1
CH Le Vinatier
Bron, France, 69678
Actively Recruiting
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Research Team
S
SARTELET Lydie
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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