Olfactory and Brain Stimulations in Treatment-resistant Depression
Recruiting · NCT05661383 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- CH Le Vinatier - Bron, France