Combining brain stimulation with pleasant odors for treating depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EEG-Guided TMS for Adults With Depression

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• Ketamine-assisted psychotherapy for treatment-resistant depression in adults

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  Recruiting Senz · Doorn, Utrecht · NCT07706478

• Mindfulness‑augmented brain stimulation for treatment‑resistant depression

  This trial will test whether combining fast brain stimulation (iTBS) with a digital mindfulness program helps people with treatment‑resistant depression reduce symptoms and improve thinking.

  Recruiting Phase 2 University of California, San Diego · San Diego, California · NCT07512284

• ipRGCs as biomarkers to predict TMS response in major depressive disorder

  This study tests whether retinal cells called ipRGCs can predict who will respond to TMS in treatment-resistant depression.

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• Rapid, robot-guided TMS with NRX-101 for treatment-resistant depression

  This trial tests whether a single-day, robot-guided brain stimulation plus NRX-101 can help adults with treatment-resistant depression compare to sham stimulation and placebo.

  Recruiting at 3 sites Phase 2/3 NeuroRx, Inc. · Sarasota, Florida and 2 other locations · NCT07227103

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.