An interventional study of Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol. and Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone. in Treatment-resistant Depression, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment
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Among 23 studies in Depressive Disorder, Treatment-Resistant with a site in France — 9 open to participants now, 10 under way, 1 of them phase 3. Depressive Disorder, Treatment-Resistant · France.
Among the 23 studies in Depressive Disorder, Treatment-Resistant with a site in France, this one is the 14th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2024, is one of 14 with no phase, and was the 16th registered.
448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.
Browse Depressive Disorder, Treatment-Resistant studies →9 of the 23 studies in Depressive Disorder, Treatment-Resistant with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier St Anne · Sites in France
Ages 18+
Centre Hospitalier St Anne · Sites in France
Ages 18+
Fondation FondaMental · Sites in France
Ages 15–60 · Healthy volunteers
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–70
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 114 Depressive Disorder, Treatment-Resistant studies recruiting now, 26 (23%) set no upper age limit and 76 (67%) stop at 75 or younger; 1 takes children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 59 across 372 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Median enrollment 119 across the 21 interventional studies, 60 across the 2 observational. Of the 11 that completed or were terminated, 5 (45%) have results posted.
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6 of 23 have an industry lead sponsor. The 10 most frequent:
Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
Hôpital le Vinatier has 1 study filed under Depressive Disorder, Treatment-Resistant — fewer than ten, so there is no comparison to draw.
2 of the studies in Depressive Disorder, Treatment-Resistant with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05577247Assistance Publique - Hôpitaux de ParisBelief Updating in Treatment Resistant Depression | 2026-12-13 |
| NCT05661383Hôpital le VinatierOlfactory and Brain Stimulations in Treatment-resistant Depression | 2027-01-27 |
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Among the 23 studies in Depressive Disorder, Treatment-Resistant with a site in France, from their registry updates:
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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.
Major depressive disorder (MDD) is the most widespread psychiatric disorder, affecting 5% of adults according to the World Health Organization. Anhedonia, defined as the loss of the ability to experience pleasure, is one of the key symptoms of depression, possibly due to a dysfunction of the reward system. Intermittent theta-burst stimulation (iTBS) targeting the dorsolateral prefrontal cortex (DLPFC) has been demonstrated as an emerging treatment option for treatment-resistant depression. One explanation is that iTBS could work through modulating the reward system (increasing dopamine release). One way to improve the therapeutic benefits of non-invasive brain stimulation is to combine it with other therapeutic strategies. Interestingly, olfactory training -daily short-term exposure to pleasant odors- improves significantly depressive symptoms in MDD patients. Indeed, the olfactory system and the reward system are closely related through the olfactory tubercle, which is in the ventral striatum and directly connected to the ventral tegmental area.
The general aim of this research project is to test whether a combination of iTBS targeting the left DLPFC with an olfactory training can improve treatment outcome in MDD, compared to iTBS targeting the left DLPFC alone.
The investigators hypothesize that combining iTBS treatment on DLPFC with hedonic olfactory stimulation potentiates the effect of iTBS treatment administered alone on depressive symptoms, especially anhedonia (physical, social or olfactory). Moreover, the investigators also hypothesize that the superiority of the combined approach is underpinned by greater modulation of connectivity activity and strength between brain regions involved in dopaminergic transmission, compared with iTBS alone.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.
Device: 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.
Device: Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.
Device: MagPro X100 (MagVenture, Mag2Health, France) iTBS protocol targeting the left dorsolateral prefrontal cortex: 50 consecutive sessions allocated on 10 days (i.e., 5 sessions per working day, 1 hour apart, for 2 weeks). One iTBS session: burst of 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., at 5 Hz) at an intensity of 90% of rMT. A 2 s train of iTBS will be repeated every 10 s for a total of 1800 pulses per session. Pleasant odorants will be delivered using passive diffusers placed in the room dedicated to the iTBS protocol, during the all-treatment duration. During the inclusion phase, 10 odors known to be pleasant will be presented to the subject. The 3 best rated by the subject will be chosen for olfactory stimulations. During the iTBS session, a randomly selected odor from the 3 will be presented at the same time as the iTBS treatment.
Device: MagPro X100 (MagVenture, Mag2Health, France) iTBS protocol targeting the left dorsolateral prefrontal cortex: 50 consecutive sessions allocated on 10 days (i.e., 5 sessions per working day, 1 hour apart, for 2 weeks). One iTBS session: burst of 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., at 5 Hz) at an intensity of 90% of rMT. A 2 s train of iTBS will be repeated every 10 s for a total of 1800 pulses per session.
Change in MADRS score before and after intervention to characterized the number of depressed patients who reach remission criteria (MADRS ≤ 10) in each group
MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to intervention. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. Remission is defined as a Montgomery and Asberg Depression Rating Scale (MADRS) score less than or equal to 10 at the end of 50 sessions of iTBS
Time frame: 4 times : before the Intervention (J0), immediately following the end of the Intervention (J15), 1 (M1) and 3 months (M3) after the end of the Intervention.
Group differences in Montgomery-Asberg Depression Rating Scale (MADRS) score changes
MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to intervention. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores indicating a more severe depression.
Time frame: 4 times : Before the Intervention (J0), immediately following the end of the Intervention (J15), 1 (M1) and 3 months (M3) after the end of the Intervention.
Group differences in Beck Depressive Inventory (BDI) score changes
BDI is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. Higher scores indicating a more severe depression
Time frame: 4 times : before the Intervention (J0), immediately following the end of the Intervention (J15), 1 (M1) and 3 months (M3) after the end of the Intervention.
Group differences in European Test of Olfactory Capabilities (ETOC) score changes
The ETOC is an olfactory test based on standardized odorants. It consists in the presentation of 16 odors at supraliminal concentrations. For each trial, 4 tubes are presented to the patient, but only one contains the odor. The participant has to find which one contains it. Then, the patient has to identify the odor between 4 propositions. Both tests are rated on 16. Another test will be performed to assess olfactory hedonic judgment. It consists of the presentation of 10 odors known to be pleasant. Hedonicity of each odor will be rated on an analog scale from 1 to 9 (1 for "Not at all pleasant", 5 for "Neutral" and 9 for "Extremly pleasant").
Time frame: 2 times : Before the Intervention (J0), immediately following the end of the Intervention (J15)
Group differences in the Chapman Social Anhedonia Scale (SAS)
The SAS is a 40-items 'true/false' self-report questionnaire designed to measure social anhedonia that refers to a marked preference for solitary activities. Scores can range from 0 to 40 with higher scores indicating less ability to experience pleasure from social and interpersonal experiences.
Time frame: 4 times : before the Intervention (J0), immediately following the end of the Intervention (J15), 1 (M1) and 3 months (M3) after the end of the Intervention.
the Chapman Physical Anhedonia Scale (PAS) score changes
The PAS is a 61-items 'true/false' self-report questionnaire designed to measure physical anhedonia that refers to the inability to experience physical pleasures related to food, touch, smells, sex, temperature, movements, sounds and physical sensations. Scores can range from 0 to 61 with higher scores indicating less ability to experience pleasure from pleasant physical stimuli.
Time frame: 4 times : before the Intervention (J0), immediately following the end of the Intervention (J15), 1 (M1) and 3 months (M3) after the end of the Intervention.
Group differences in conditioned motor evoked potential (MEP) peak-to-peak amplitude changes
Dual-site transcranial magnetic stimulation (TMS) can be used to probe effective connectivity between the left DLPFC and the left M1. Conditioned MEP amplitude evoked by dual-site TMS and measured with surface EMG is compared to MEP amplitude evoked by TMS applied over M1 alone.
Time frame: 2 times : before the Intervention (J0), immediately following the end of the Intervention (J15)
Group differences in functional connectivity changes in the targeted brain network
Resting state functional magnetic resonance imaging (fMRI) is used to probe functional connectivity changes in the targeted brain region and related network following non-invasive brain stimulation intervention.
Time frame: 2 times : before the Intervention (J0), immediately following the end of the Intervention (J15)
Group differences in the Childhood Trauma Questionnaire (CTQ) score changes
The CTQ is a self-administered 28-item scale to measure abuse and neglect suffered in childhood on five subscales: emotional, physical / sexual abuse, and emotional / physical neglect. Each subscale scored on a 5-point Likert scale. The score for each subscale classifies the severity of the abuse and neglect as: "none to minimal," "low to moderate," "moderate to severe" and "severe to extreme".
Time frame: 1 time : Before the Intervention (J0)
Plan to share: Undecided — Describe the IPD sharing plan, including what IPD are to be shared with other researchers.
Started Jan 2024 (actual). Primary completion is estimated for Jan 2027, 36 months after the start.
Of 136 non-industry interventional studies with no phase under Depressive Disorder, Treatment-Resistant, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 79. This study's planned 36 months is below that.
Counting every sponsor, half of 140 studies reached it within 50 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
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Depressive Disorder, Treatment-Resistant →