Autism Spectrum DisorderDEPASS'RNCT07258914
Feasibility and Efficacy of rTMS in Depression in Patients With Autism Spectrum Disorder (ASD)
A study testing rTMS and rTMS treatment with intermittent Theta Burst (ITBS) in people with Autism Spectrum Disorder and Depression, run by Hospital Center Guillaume Régnier at 1 site in France.
Trial summary
Depression is a common complication of Autism Spectrum Disorder (ASD): it is four times more prevalent in people with ASD than in the general population. However, treating depression in people with ASD is complicated by the lack of guidelines. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder, Depression, Major Depressive Episode (MDE)
- What is being tested?
- rTMS and rTMS treatment with intermittent Theta Burst (ITBS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2024to 19 Feb 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a diagnosis of ASD validated by a psychiatrist or line 2
- Patient aged 18 to 65...
- Patients suffering from EDM (MADRS greater than 20)
- No change in treatment in the month prior to inclusion
- Patients affiliated with or entitled to social security
- Patients who have received informed information about the study and have signed a consent form to participate in the study
Who cannot join
- Patients with psychiatric comorbidity (decompensated manic state, schizophrenic disorder)
- Pregnancy at the time of inclusion
- Patients with contraindications to rTMS and MRI (history of epilepsy, neurological stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metal fragments in the eyes, claustrophobia)
- Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty, persons hospitalised under compulsion (SDT, SDRE).
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
Centre Hospitalier Guillaume Régnier
Rennes, 35000
Cécilia NAUCZYCIEL, +332 99 68 29 63 ext. +33, c.nauczyciel@ch-guillaumeregnier.fr
Nathalie ALLETON, +332 22 51 41 21 ext. +33, driri@ch-guillaumeregnier.fr
About this study
Official title: Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)
Depression is a common complication of Autism Spectrum Disorder (ASD): it is four times more prevalent in people with ASD than in the general population.
However, treating depression in people with ASD is complicated by the lack of guidelines. Antidepressants appear to be less effective and less well tolerated than in the general population.
Read more
rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates the brain in a painless and non-invasive way. This technique is well tolerated and has very few side effects (headaches, fatigue). It is now used routinely in clinical practice to treat resistant depression, with satisfactory results.
A few studies using rTMS in depression in people with ASD have shown encouraging results and avenues for improvement.
It could therefore be interesting to conduct a therapeutic study with rTMS on depression in people with ASD, following the avenues for improvement proposed by previous studies.
The main objective is to evaluate the effectiveness of rTMS in depressed patients with ASD by looking at changes in mood before and after treatment. The investigator will also look at the effects on executive and attentional functions and repetitive behaviors, as well as treatment tolerance.
Read the detailed description
Depression is a common comorbidity of autism spectrum disorder (ASD). Its prevalence is four times higher than in the neurotypical population, with specific symptoms, particularly irritability. However, the management of major depressive episodes (MDEs) in patients with ASD is complicated by the lack of specific recommendations for depression in ASD, while the effectiveness of pharmacological treatments is limited in this context.
rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates brain tissue in a non-invasive and painless manner, with good tolerance and few side effects. In the neurotypical population, it is used routinely in clinical practice to treat resistant EDMs, with satisfactory results.
To date, there are few studies on the treatment of depression in patients with ASD using TMS. Although these studies have certain limitations, they have shown encouraging results. These two studies are open-label studies involving fewer than 20 patients, but they show a significant improvement in depression scales before and after TMS treatment. The stimulation parameters (stimulation target: left dorsolateral prefrontal cortex, 15 to 30 sessions at a rate of one session per day, stimulation frequency of 10Hz for the first study and 50Hz in theta burst for the second) are those used in studies on depression in neurotypical depressed patients. In addition to the small sample size, these open-label studies have limitations in terms of parameter potentiation (target localisation, number of pulses per session and per day). It may therefore be worthwhile conducting a preliminary study to assess the feasibility and efficacy of rTMS in depressed ASD patients using an innovative accelerated, high-dose intermittent theta burst stimulation protocol with precise targeting of the stimulation site using neuronavigation and a detailed assessment of clinical depression in ASD, including irritability. Furthermore, an improvement in cognitive functions has been observed in neurotypical depressed patients receiving rTMS at the dorsolateral prefrontal cortex. It would therefore be interesting to study the impact of rTMS on executive and attentional functions using these innovative stimulation parameters.
- Being tested
- rTMS, rTMS treatment with intermittent Theta Burst (ITBS)
- Keywords
- Autism Spectrum Disorder, Depression, Major Depressive Episode (MDE), Transcranial Magnetic Stimulation, Repetitive Transcranial Magnectic Stimulation (rTMS), rTMS, Neurodivergent, executive and attentional function
- Medical subject headings
- Autism Spectrum Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
Patients receive 20 sessions of intermittent theta burst stimulation of the left CPFDL over 5 days (4 sessions of 10 minutes per day with a 50-minute interval between each session). The CPFDL is located using neuronavigation, which requires an MRI scan (without contrast agent injection) before the sessions.
rTMS treatment with intermittent Theta Burst (ITBS)Other
rTMS (iTBS) treatment with stimulation of the left dorsolateral prefrontal cortex (DLPFC). Localization is performed using neuronavigation. There are four 10-minute sessions per day, with a 50-minute interval between each session.
| Study group | Role | What they receive |
|---|---|---|
| ASD patients with depression | Experimental | Patients receive 4 sessions of 10 minutes per day with a 50-minute interval between each session Receives: Other: rTMS; Other: rTMS treatment with intermittent Theta Burst (ITBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment.
Upon inclusion, patients are assessed for mood using the MADRS.(inclusion criterion: MADRS>20).
The primary endpoint is the change in MADRS score one week after the end of treatment and one month after the end of treatment.
score ranges from 0 to 60. The higher the score, the more severe the disorder is.
Measured: From enrollment to the end of the data collecting process : 2 months.
Secondary outcomes (9)
Assessment of changes in irritability before versus after treatment
Irritability is assessed with the Angst scale. A global score of 10 or more indicates irritability.
Measured: from enrolment to one month after the end of the rTMS treatment
assessment of changes in attention functions
Attentional functions are assessed using two subtests of the TAP (Test of Attentional Performance):
- sustained attention : The test measures the ability to maintain attention over the long term with a high density of target stimuli.
- Split Attention : The test explores the Ability to focus attention on two tasks simultaneously.
Measured: From enrolment to one week then 1 month after the end of the rTMS treatment
Evolution of any side effects
Assessment of side effects of rTMS using the UKU scale
Measured: During the treatment, at each stimulation time
Assement of change in repetitive behaviors before versus after treatment
BPI-1 (Behavior Problems Inventory) is an informant-based behaviour rating instrument that was designed to assess maladaptive behaviours in individuals with ASD. Its items fall into one of three sub-scales: Self-injurious Behavior (14 items), Stereotyped Behavior (24 items), and Aggressive/Destructive Behavior (11 items). Each item is rated on a frequency scale (0 = never to 4 = hourly), and a severity scale (0 = no problem to 3 = severe problem).
Measured: from enrolment and 1 month after the end of rTMS treatment
assessment of changes in mood aspects in terms of psychomotor decline before versus after rTMS treatment
psychomotor decline is assessed with the depressive decline scale (ERD).This tool contains 14 items that describe the motor, verbal, ideational, hedonic, and cognitive behavior of depressed individuals. Each item is rated from 0 to 4 ( 1 expressing doubt about the pathological nature of the observed phenomenon).
Measured: from enrolment to one week then one month after the end of the rTMS treatment
assessment of changes in mood aspects in terms of depression before versus after rTMS treatment
Depression is assessed with the Patient Health Questionnaire - 9 items (PHQ-9) This is a brief tool used to assess and measure the severity of depression. Items are rated on a scale from 0 to 3. The maximum score is 27 (major depression)
Measured: From enrolment to one week then one month after the end of the rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
The TMT (Trial Making Test) measures attention, visual screening ability, and processing speed. The Trail Making Test is scored by how long it takes to complete the test
Measured: From enrolment and 1 month after the end of rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
The Stroop test measures recognition reaction times to color stimuli, evaluating psychomotor speed and cognitive flexibility.
Measured: From enrolment and 1 month after the end of rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
The GO/NO GO task measures the ability to inhibit and the control of impulses
Measured: From enrolment and 1 month after the end of rTMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start19 Dec 2024
- Primary completion19 Feb 2026 (estimated)
- Study completion19 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Center Guillaume Régnier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécilia NAUCZYCIEL, Doctor, Principal investigator, Centre Hospitalier Guillaume Régnier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258914
- Sponsor's protocol ID
- RC24_01_CN_DEPASS'R
- Other IDs
- 2024-A01125-42
- Acronym
- DEPASS'R
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data about study protocol and clinical information will be available on request from other researchers.
Publications
Smith JR, DiSalvo M, Green A, Ceranoglu TA, Anteraper SA, Croarkin P, Joshi G. Treatment Response of Transcranial Magnetic Stimulation in Intellectually Capable Youth and Young Adults with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2023 Dec;33(4):834-855. doi: 10.1007/s11065-022-09564-1. Epub 2022 Sep 26.
PubMed 36161554Tong J, Zhang J, Jin Y, Liu W, Wang H, Huang Y, Shi D, Zhu M, Zhu N, Zhang T, Sun X. Impact of Repetitive Transcranial Magnetic Stimulation (rTMS) on Theory of Mind and Executive Function in Major Depressive Disorder and Its Correlation with Brain-Derived Neurotrophic Factor (BDNF): A Randomized, Double-Blind, Sham-Controlled Trial. Brain Sci. 2021 Jun 9;11(6):765. doi: 10.3390/brainsci11060765.
PubMed 34207545Noda Y, Fujii K, Mimura Y, Taniguchi K, Nakajima S, Kitahata R. A Case Series of Intermittent Theta Burst Stimulation Treatment for Depressive Symptoms in Individuals with Autistic Spectrum Disorder: Real World TMS Study in the Tokyo Metropolitan Area. J Pers Med. 2023 Jan 11;13(1):145. doi: 10.3390/jpm13010145.
PubMed 36675806Gwynette MF, Lowe DW, Henneberry EA, Sahlem GL, Wiley MG, Alsarraf H, Russo SB, Joseph JE, Summers PM, Lohnes L, George MS. Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study. Autism Res. 2020 Mar;13(3):346-351. doi: 10.1002/aur.2266. Epub 2020 Jan 15.
PubMed 31944611Hudson CC, Hall L, Harkness KL. Prevalence of Depressive Disorders in Individuals with Autism Spectrum Disorder: a Meta-Analysis. J Abnorm Child Psychol. 2019 Jan;47(1):165-175. doi: 10.1007/s10802-018-0402-1.
PubMed 29497980
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT07258914
- Acronym / sponsor ID
- DEPASS'R / RC24_01_CN_DEPASS'R
- Keywords
- Autism Spectrum Disorder, Depression, Major Depressive Episode (MDE), Transcranial Magnetic Stimulation, Repetitive Transcranial Magnectic Stimulation (rTMS), rTMS, Neurodivergent, executive and attentional function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospital Center Guillaume RégnierUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 19 Feb 2026 (estimated)
- Study completion
- 19 Feb 2026 (estimated)
- First posted
- 2 Dec 2025 (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.
Depression is a common complication of Autism Spectrum Disorder (ASD): it is four times more prevalent in people with ASD than in the general population.
However, treating depression in people with ASD is complicated by the lack of guidelines. Antidepressants appear to be less effective and less well tolerated than in the general population.
rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates the brain in a painless and non-invasive way. This technique is well tolerated and has very few side effects (headaches, fatigue). It is now used routinely in clinical practice to treat resistant depression, with satisfactory results.
A few studies using rTMS in depression in people with ASD have shown encouraging results and avenues for improvement.
It could therefore be interesting to conduct a therapeutic study with rTMS on depression in people with ASD, following the avenues for improvement proposed by previous studies.
The main objective is to evaluate the effectiveness of rTMS in depressed patients with ASD by looking at changes in mood before and after treatment. The investigator will also look at the effects on executive and attentional functions and repetitive behaviors, as well as treatment tolerance.
Detailed description
Depression is a common comorbidity of autism spectrum disorder (ASD). Its prevalence is four times higher than in the neurotypical population, with specific symptoms, particularly irritability. However, the management of major depressive episodes (MDEs) in patients with ASD is complicated by the lack of specific recommendations for depression in ASD, while the effectiveness of pharmacological treatments is limited in this context.
rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates brain tissue in a non-invasive and painless manner, with good tolerance and few side effects. In the neurotypical population, it is used routinely in clinical practice to treat resistant EDMs, with satisfactory results.
To date, there are few studies on the treatment of depression in patients with ASD using TMS. Although these studies have certain limitations, they have shown encouraging results. These two studies are open-label studies involving fewer than 20 patients, but they show a significant improvement in depression scales before and after TMS treatment. The stimulation parameters (stimulation target: left dorsolateral prefrontal cortex, 15 to 30 sessions at a rate of one session per day, stimulation frequency of 10Hz for the first study and 50Hz in theta burst for the second) are those used in studies on depression in neurotypical depressed patients. In addition to the small sample size, these open-label studies have limitations in terms of parameter potentiation (target localisation, number of pulses per session and per day). It may therefore be worthwhile conducting a preliminary study to assess the feasibility and efficacy of rTMS in depressed ASD patients using an innovative accelerated, high-dose intermittent theta burst stimulation protocol with precise targeting of the stimulation site using neuronavigation and a detailed assessment of clinical depression in ASD, including irritability. Furthermore, an improvement in cognitive functions has been observed in neurotypical depressed patients receiving rTMS at the dorsolateral prefrontal cortex. It would therefore be interesting to study the impact of rTMS on executive and attentional functions using these innovative stimulation parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD patients with depression | Experimental | Other: rTMS, Other: rTMS treatment with intermittent Theta Burst (ITBS)Patients receive 4 sessions of 10 minutes per day with a 50-minute interval between each session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with a diagnosis of ASD validated by a psychiatrist or line 2
- Patient aged 18 to 65...
- Patients suffering from EDM (MADRS greater than 20)
- No change in treatment in the month prior to inclusion
- Patients affiliated with or entitled to social security
Key exclusion criteria (4 listed)
- Patients with psychiatric comorbidity (decompensated manic state, schizophrenic disorder)
- Pregnancy at the time of inclusion
- Patients with contraindications to rTMS and MRI (history of epilepsy, neurological stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metal fragments in the eyes, claustrophobia)
- Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty, persons hospitalised under compulsion (SDT, SDRE).
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 |
|---|---|---|
| rTMSPatients receive 20 sessions of intermittent theta burst stimulation of the left CPFDL over 5 days (4 sessions of 10 minutes per day with a 50-minute interval between each session). The CPFDL is located using neuronavigation, which requires an MRI scan (without contrast agent injection) before the sessions. | Other | ASD patients with depression |
| rTMS treatment with intermittent Theta Burst (ITBS)rTMS (iTBS) treatment with stimulation of the left dorsolateral prefrontal cortex (DLPFC). Localization is performed using neuronavigation. There are four 10-minute sessions per day, with a 50-minute interval between each session. | Other | ASD patients with depression |
Primary outcome
Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment.
Time frame: From enrollment to the end of the data collecting process : 2 months.
Upon inclusion, patients are assessed for mood using the MADRS.(inclusion criterion: MADRS>20). The primary endpoint is the change in MADRS score one week after the end of treatment and one month after the end of treatment. score ranges from 0 to 60. The higher the score, the more severe the disorder is.
9 secondary outcomes
Assessment of changes in irritability before versus after treatment
Time frame: from enrolment to one month after the end of the rTMS treatment
assessment of changes in attention functions
Time frame: From enrolment to one week then 1 month after the end of the rTMS treatment
Evolution of any side effects
Time frame: During the treatment, at each stimulation time
Assement of change in repetitive behaviors before versus after treatment
Time frame: from enrolment and 1 month after the end of rTMS treatment
assessment of changes in mood aspects in terms of psychomotor decline before versus after rTMS treatment
Time frame: from enrolment to one week then one month after the end of the rTMS treatment
assessment of changes in mood aspects in terms of depression before versus after rTMS treatment
Time frame: From enrolment to one week then one month after the end of the rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
Time frame: From enrolment and 1 month after the end of rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
Time frame: From enrolment and 1 month after the end of rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
Time frame: From enrolment and 1 month after the end of rTMS treatment
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 2 Dec 2025.
- Background: PubMed 36161554Smith JR, DiSalvo M, Green A, Ceranoglu TA, Anteraper SA, Croarkin P, Joshi G. Treatment Response of Transcranial Magnetic Stimulation in Intellectually Capable Youth and Young Adults with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2023 Dec;33(4):834-855. doi: 10.1007/s11065-022-09564-1. Epub 2022 Sep 26.
- Background: PubMed 34207545Tong J, Zhang J, Jin Y, Liu W, Wang H, Huang Y, Shi D, Zhu M, Zhu N, Zhang T, Sun X. Impact of Repetitive Transcranial Magnetic Stimulation (rTMS) on Theory of Mind and Executive Function in Major Depressive Disorder and Its Correlation with Brain-Derived Neurotrophic Factor (BDNF): A Randomized, Double-Blind, Sham-Controlled Trial. Brain Sci. 2021 Jun 9;11(6):765. doi: 10.3390/brainsci11060765.
- Background: PubMed 36675806Noda Y, Fujii K, Mimura Y, Taniguchi K, Nakajima S, Kitahata R. A Case Series of Intermittent Theta Burst Stimulation Treatment for Depressive Symptoms in Individuals with Autistic Spectrum Disorder: Real World TMS Study in the Tokyo Metropolitan Area. J Pers Med. 2023 Jan 11;13(1):145. doi: 10.3390/jpm13010145.
- Background: PubMed 31944611Gwynette MF, Lowe DW, Henneberry EA, Sahlem GL, Wiley MG, Alsarraf H, Russo SB, Joseph JE, Summers PM, Lohnes L, George MS. Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study. Autism Res. 2020 Mar;13(3):346-351. doi: 10.1002/aur.2266. Epub 2020 Jan 15.
- Background: PubMed 29497980Hudson CC, Hall L, Harkness KL. Prevalence of Depressive Disorders in Individuals with Autism Spectrum Disorder: a Meta-Analysis. J Abnorm Child Psychol. 2019 Jan;47(1):165-175. doi: 10.1007/s10802-018-0402-1.
- Individual participant dataSharing planned: No. Data about study protocol and clinical information will be available on request from 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.
Centre Hospitalier Guillaume Régnier
Rennes, France
Cécilia NAUCZYCIEL, Doctor principal investigator
Centre Hospitalier Guillaume Régnier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and rTMS treatment with intermittent Theta Burst (ITBS) in people with Autism Spectrum Disorder and Depression, run by Hospital Center Guillaume Régnier 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 6 inclusion and 4 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 2 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment. (time frame: From enrollment to the end of the data collecting process : 2 months.). 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 NCT07258914, which also lists 5 linked publications.
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 2 Dec 2025.