NCT05661383 Olfactory and Brain Stimulations in Treatment-resistant Depression
| NCT ID | NCT05661383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital le Vinatier |
| Condition | Treatment-resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-27 |
| Primary Completion | 2027-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-01-27 with a primary completion date of 2027-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
BRUNELIN JEROME, PhD
PRINCIPAL INVESTIGATOR
hospital le vinatier
Frequently Asked Questions
Who can join the NCT05661383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Treatment-resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05661383 currently recruiting?
Yes, NCT05661383 is actively recruiting participants. Contact the research team at lydie.sartelet@ch-le-vinatier.fr for enrollment information.
Where is the NCT05661383 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT05661383 clinical trial?
NCT05661383 is sponsored by Hôpital le Vinatier. The principal investigator is BRUNELIN JEROME, PhD at hospital le vinatier. The trial plans to enroll 80 participants.
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