Treatment-resistant DepressionCOBRANCT05661383
Olfactory and Brain Stimulations in Treatment-resistant Depression
A study testing 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 people with Treatment-resistant Depression, run by Hôpital le Vinatier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment-resistant Depression
- What is being tested?
- 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.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2024to 2 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CH Le Vinatier
Bron, 69678
BRUNLIN Jérôme, PhD, 0437915565 ext. +33, jerome.brunelin@ch-le-vinatier.fr
About this study
Official title: Combining Hedonic Olfactory and BRAin Stimulations in Treatment-resistant Depression
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.
Read the detailed description
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.
- Conditions
- Treatment-resistant Depression
- Being 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.
- Keywords
- Depression, brain stimulation, anhedonia, odor
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.Device
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.
Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| iTBS active combined with an olfactory stimulation | Experimental | Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol. Receives: Device: Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol. |
| iTBS active alone | Active comparator | Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone. Receives: Device: Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (8)
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.
Measured: 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
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 1 time : Before the Intervention (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start27 Jan 2024
- Primary completion27 Jan 2027 (estimated)
- Study completion2 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant DepressionStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, randomized, double-blind, parallel-group controlled trial with two arms
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France
- Responsible party
- Sponsor
- Investigators
- BRUNELIN JEROME, PhD, Principal investigator, hospital le vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661383
- Sponsor's protocol ID
- 2022-A01967-36
- Acronym
- COBRA
- Status last verified
- Jul 2025
- First submitted
- 23 Nov 2022
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Describe the IPD sharing plan, including what IPD are to be shared with other researchers.
Publications
Imbert L, Neige C, Dumas M, Bensafi M, Mandairon N, Brunelin J. Combining pleasant Olfactory and BRAin stimulations in treatment-resistant depression (COBRA): study protocol for a randomized controlled trial. Front Psychol. 2024 Dec 17;15:1451096. doi: 10.3389/fpsyg.2024.1451096. eCollection 2024.
PubMed 39744036
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Hedonic Olfactory and BRAin Stimulations in Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT05661383
- Acronym / sponsor ID
- COBRA / 2022-A01967-36
- Conditions
- Treatment-resistant Depression
- Keywords
- Depression, brain stimulation, anhedonia, odor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- Fondation de France
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- 27 Jan 2027 (estimated)
- Study completion
- 2 Oct 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-center, randomized, double-blind, parallel-group controlled trial with two arms
| Arm | Type | Receives |
|---|---|---|
| iTBS active combined with an olfactory stimulation | Experimental | 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)) combined with pleasant odors delivered during the iTBS procol. |
| iTBS active alone | Active comparator | Device: Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.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 | iTBS active combined with an olfactory stimulation |
| 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. | Device | iTBS active alone |
Primary outcome
Change in MADRS score before and after intervention to characterized the number of depressed patients who reach remission criteria (MADRS ≤ 10) in each group
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.
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
8 secondary outcomes
Group differences in Montgomery-Asberg Depression Rating Scale (MADRS) score changes
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
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
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)
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
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
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
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
Time frame: 1 time : Before the Intervention (J0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 39744036Imbert L, Neige C, Dumas M, Bensafi M, Mandairon N, Brunelin J. Combining pleasant Olfactory and BRAin stimulations in treatment-resistant depression (COBRA): study protocol for a randomized controlled trial. Front Psychol. 2024 Dec 17;15:1451096. doi: 10.3389/fpsyg.2024.1451096. eCollection 2024.
- Individual participant dataSharing planned: Undecided. Describe the IPD sharing plan, including what IPD are to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BRUNELIN JEROME, PhD principal investigator
hospital le vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Treatment-resistant Depression, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SARTELET Lydie (0437915531 ext. +33, lydie.sartelet@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS score before and after intervention to characterized the number of depressed patients who reach remission criteria (MADRS ≤ 10) in each group (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.