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Olfactory and Brain Stimulations in Treatment-resistant Depression

RECRUITINGN/ASponsored by Hôpital le Vinatier
Actively Recruiting
PhaseN/A
SponsorHôpital le Vinatier
Started2024-01-27
Est. completion2027-01-27
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

DepressionTreatment-resistant Depression

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