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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
View on ClinicalTrials.gov →
NCT05661383
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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Actively Recruiting
PhaseN/A
SponsorHôpital le Vinatier
Started2024-01-27
Est. completion2027-01-27
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05661383