Combining brain stimulation with pleasant odors for treating depression
Combining Hedonic Olfactory and BRAin Stimulations in Treatment-resistant Depression
This study is testing whether combining brain stimulation with pleasant smells can help people with treatment-resistant depression feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital le Vinatier Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT05661383 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intermittent theta-burst stimulation (iTBS) combined with olfactory training in patients with treatment-resistant major depressive disorder (MDD). Participants will be randomly assigned to receive either iTBS alone or iTBS with pleasant odors to determine which approach yields better clinical outcomes. The study focuses on improving symptoms of depression, particularly anhedonia, by leveraging the connection between the olfactory and reward systems in the brain. The trial will assess changes in depressive symptoms using standardized rating scales.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with treatment-resistant major depressive disorder who have not responded to standard antidepressant therapies.
Not a fit: Patients with conditions affecting olfaction or those with other psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from treatment-resistant depression.
How similar studies have performed: While the combination of brain stimulation and olfactory training is a novel approach, previous studies have shown promise in using brain stimulation for depression treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bron
- CH Le Vinatier — Bron, France (Recruiting)
Study contacts
- Principal investigator: BRUNELIN JEROME, PhD — hospital le vinatier
- Study coordinator: SARTELET Lydie
- Email: lydie.sartelet@ch-le-vinatier.fr
- Phone: 0437915531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.