Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05661383

Olfactory and Brain Stimulations in Treatment-resistant Depression

Led by Hôpital le Vinatier · Updated on 2025-07-24

80

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

Sponsors

H

Hôpital le Vinatier

Lead Sponsor

F

Fondation de France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Olfactory and Brain Stimulations in Treatment-resistant Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of single-episode or recurrent non-psychotic major depressive disorder according to DSM-5 criteria
  • Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or higher
  • MADRS anhedonia factor score higher than 2
  • Stable antidepressant medication for at least 4 weeks before joining
  • Ability to speak and read French
  • Signed informed consent form before intervention
Not Eligible

You will not qualify if you...

  • Pre-existing conditions affecting sense of smell, such as congenital anosmia, upper respiratory infection, nasal or sinus disease, brain injury, or nasal surgery
  • Neurological diseases
  • Other psychiatric disorders or substance abuse except tobacco
  • Contraindications to transcranial magnetic stimulation (TMS), such as implanted medical devices or metallic foreign bodies in the head
  • Pregnant or breastfeeding women
  • Under legal protection or guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CH Le Vinatier

Bron, France, 69678

Actively Recruiting

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Research Team

S

SARTELET Lydie

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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