Major Depressive DisorderDEP&MODNCT06451809
Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on Heart Rate Variability
An observational study of Major Depressive Disorder, run by GCS CIPS at 9 sites in France.
Trial summary
Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 9 sitesFrance
- Study dates
- 13 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients recruited will be patients who have been admitted as an outpatient for the treatment of MDD by rTMS treatment at one of the 9 study centres.
Who may be able to join
- Having a prescription for a course of rTMS to treat an episod of MDD
- Unipolar MDD confirmed according to DSM-5 criteria
- Moderate to severe MDD (MADRS score > 19)
- No use of psychotropic medication or use stabilised (no change in dose < 4 weeks before study entry)
- Able to understand, speak, read and write French
- Express informed consent, after a period of reflection
- Affiliated with a French social security scheme or beneficiary of such a scheme
Who cannot join
- History of epilepsy or convulsive seizures
- Previous brain surgery
- History of recent cranial trauma (< 6 months)
- Presence of severe suicidal ideation
- Psychotic disorders
- Metal objects in the head, eyes or brain
Show all 16Show fewer
- Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)
- Clinical evidence of serious or uncontrolled alcohol or substance use disorders in the three months prior to the study
- Active withdrawal from alcohol or other substances
- One or more recent rTMS sessions (< 4 weeks)
- Other non-drug therapy recently initiated (< 4 weeks) to treat MDD (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
- Prescription of cardiotropic drugs belonging to the following classes: predominantly cardiac calcium channel blockers, Vaughan Williams class I anti-arrhythmics and beta-blockers.
- Subjects in a period of relative exclusion from another protocol
- Adults protected by law or patients under guardianship or curatorship
- Subjects deprived of their liberty by judicial or administrative decision
- Pregnant or breast-feeding women
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Clinique Inicea du Pays de Seine
Bois-le-Roi, 77590
Clinique Inicea La Mare O Dans
Les Damps, 27340
Clinique Inicea Villa des Roses
Lyon, 69005
Etablissement public de santé de Ville-Evrard
Neuilly-sur-Marne, 93330
Centre médical de psychiatrie NeuroStim Luxembourg
Paris, 75005
Centre médical de psychiatrie NeuroStim Etoile
Paris, 75016
Clinique Inicea Jeanne d'Arc Hopital Privé Parisien
Saint-Mandé, 94160
Centre montois de psychiatrie ambulatoire Inicea
Saint-Pierre-du-Mont, 40280
Centre Tourangeau de psychiatrie ambulatoire Inicea
Tours, 37000
About this study
Official title: Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on the Acute Variation in Heart Rate Variability Obtained After a Single RTMS Session in Patients with Major Depressive Disorder
Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD).
Read the detailed description
The objective of this study is to investigate whether acute changes in heart rate variability following a single session of repetitive transcranial magnetic stimulation (rTMS) can predict the response to a 30-session course of rTMS in patients with major depressive disorder (MDD) with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the start of the rTMS course, the patient will have to fill in a number of questionnaires. Before the first session, heart rate variability will be assessed by recording the RR interval at rest using a heart rate belt on the armchair stimulation. A second RR interval recording will be taken immediately after the first rTMS session. Patients will answer questionnaires weekly and after the final rTMS session to track the progression of depressive symptoms.
- Conditions
- Major Depressive Disorder
- Being tested
- repetitive transcranial magnetic stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
rTMS will be applied 5 days out of 7 for 6 weeks, for a total of 30 sessions. The area stimulated will be the left dorsolateral prefrontal cortex, at a frequency of 10 Hz, at 110% of motor threshold for approximately 20 minutes (i.e. 3,000 stimulations per session).
| Study group | Role | What they receive |
|---|---|---|
| Patients with MDD | Patients who are prescribed a course of 30 rTMS sessions to treat an episode of MDD at one of the nine participating centres Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold of variation in terms of RMSSD between normal heartbeats enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
Threshold of variation in terms of RMSSD (root mean square of successive differences) between normal heartbeats after a single rTMS session enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. The response to the course of rTMS will be assessed via the evolution of the MADRS score (decrease of MADRS score >50%)
Measured: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Secondary outcomes (2)
Threshold of other heart rate variability markers enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
Threshold of variation in other heart rate variability markers (SDNN, low frequencies, high frequencies and low to high frequencies ratio) after a single rTMS session enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. The response to the course of rTMS will be assessed via the evolution of the MADRS score (decrease of MADRS score >50%)
Measured: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Threshold of variation in heart rate variability markers enabling to predict the remission to the course of rTMS with the best possible sensitivity and specificity.
Threshold of variation in heart rate variability markers (RMSSD, SDNN, low frequencies, high frequencies and low to high frequencies ratio) after a single rTMS session enabling to predict the remission to the course of rTMS with the best possible sensitivity and specificity. The remission to the course of rTMS will be assessed via the evolution of the MADRS score (MADRS ≤ 10 after the course of rTMS)
Measured: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start13 Jun 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: We are faced with a decrease in rTMS activity at the study sites, as well as problems with the active file meeting the protocol inclusion criteria, resulting in a low recruitment rate and an extended study timetable, forcing us to suspend this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS CIPS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fariba Kabirian, MD, Principal investigator, France Chief Medical Officer, Clariane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451809
- Sponsor's protocol ID
- DEP&MOD
- Acronym
- DEP&MOD
- Status last verified
- Mar 2025
- First submitted
- 29 May 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on the Acute Variation in Heart Rate Variability Obtained After a Single RTMS Session in Patients with Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06451809
- Acronym / sponsor ID
- DEP&MOD / DEP&MOD
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: We are faced with a decrease in rTMS activity at the study sites, as well as problems with the active file meeting the protocol inclusion criteria, resulting in a low recruitment rate and an extended study timetable, forcing us to suspend this study.
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- GCS CIPSUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 11 Jun 2024 (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.
Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD).
Detailed description
The objective of this study is to investigate whether acute changes in heart rate variability following a single session of repetitive transcranial magnetic stimulation (rTMS) can predict the response to a 30-session course of rTMS in patients with major depressive disorder (MDD) with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the start of the rTMS course, the patient will have to fill in a number of questionnaires. Before the first session, heart rate variability will be assessed by recording the RR interval at rest using a heart rate belt on the armchair stimulation. A second RR interval recording will be taken immediately after the first rTMS session. Patients will answer questionnaires weekly and after the final rTMS session to track the progression of depressive symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MDD | – | Device: repetitive transcranial magnetic stimulationPatients who are prescribed a course of 30 rTMS sessions to treat an episode of MDD at one of the nine participating centres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited will be patients who have been admitted as an outpatient for the treatment of MDD by rTMS treatment at one of the 9 study centres.
Key inclusion criteria (7 listed)
- Having a prescription for a course of rTMS to treat an episod of MDD
- Unipolar MDD confirmed according to DSM-5 criteria
- Moderate to severe MDD (MADRS score > 19)
- No use of psychotropic medication or use stabilised (no change in dose < 4 weeks before study entry)
- Able to understand, speak, read and write French
Key exclusion criteria (16 listed)
- History of epilepsy or convulsive seizures
- Previous brain surgery
- History of recent cranial trauma (< 6 months)
- Presence of severe suicidal ideation
- Psychotic disorders
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationrTMS will be applied 5 days out of 7 for 6 weeks, for a total of 30 sessions. The area stimulated will be the left dorsolateral prefrontal cortex, at a frequency of 10 Hz, at 110% of motor threshold for approximately 20 minutes (i.e. 3,000 stimulations per session). | Device | Patients with MDD |
Primary outcome
Threshold of variation in terms of RMSSD between normal heartbeats enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
Time frame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Threshold of variation in terms of RMSSD (root mean square of successive differences) between normal heartbeats after a single rTMS session enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. The response to the course of rTMS will be assessed via the evolution of the MADRS score (decrease of MADRS score >50%)
2 secondary outcomes
Threshold of other heart rate variability markers enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
Time frame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Threshold of variation in heart rate variability markers enabling to predict the remission to the course of rTMS with the best possible sensitivity and specificity.
Time frame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Fariba Kabirian, MD principal investigator
France Chief Medical Officer, Clariane
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by GCS CIPS at 9 sites 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 7 inclusion and 16 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: paused, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold of variation in terms of RMSSD between normal heartbeats enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. (time frame: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.