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Not Yet Recruiting NCT05661383

Olfactory and Brain Stimulations in Treatment-resistant Depression

Conditions: Treatment-resistant Depression

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 80
Sponsor: Hôpital le Vinatier

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05661383). StuddyBuddy aggregates publicly available trial information.