NCT05661383Recruiting
Olfactory and Brain Stimulations in Treatment-resistant Depression
Combining Hedonic Olfactory and BRAin Stimulations in Treatment-resistant Depression
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 23 Nov 2022
- Start date
- 27 Jan 2024
- Primary completion date
- 27 Jan 2027
- Lead sponsor
- Hôpital le Vinatier
- Diseases
- Depression
- NCT number
- NCT05661383
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 27 Jan 2024 to the primary completion date, 27 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH Le Vinatier Coordinator of this site? Confirm its status | Bron | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.