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Taking people in FranceNo phase

Tests brain stimulation with pleasant odors for treatment-resistant depression

Compares brain stimulation alone with brain stimulation plus pleasant odors in adults with depression.

Key facts

Who runs it
Hôpital le Vinatier
Where
Bron, FranceSee the site
Trial code
Registry title
Olfactory and Brain Stimulations in Treatment-resistant Depression
Status
Recruiting
People taking part
80 people, planned
Started
27 Jan 2024
Expected to end
2 Oct 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.
  • Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.
Record updated
24 July 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depression who have not improved enough with treatment. It compares brain stimulation alone with brain stimulation plus pleasant smells.

Age
18 years or older
Sex
All sexes can join
Disease stage
Major depressive disorder, single episode or recurrent, without psychosis. MADRS score of 20 or over, and higher than 2 on the MADRS anhedonia item (item 8).
Earlier treatment
A stable antidepressant medication for 4 weeks before joining.

Main reasons for not taking part

  • A condition that affects the sense of smell, such as congenital anosmia, nasal or sinus disease, or nasal surgery
  • A neurological disease or brain injury
  • Other psychiatric disorders or substance abuse (tobacco is allowed)
  • Implanted medical devices or metal objects in the head
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in France

  • CH Le VinatierBron, FranceContact: BRUNLIN Jérôme, PhDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • iTBS active combined with an olfactory stimulationTreatment being tested

    Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.

    Treatment: Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.

  • iTBS active aloneExisting treatment, for comparison

    Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.

    Treatment: Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Combining Hedonic Olfactory and BRAin Stimulations in Treatment-resistant Depression
Plain-language title
Tests brain stimulation with pleasant odors for treatment-resistant depressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 July 2025