Major Depressive DisorderSPEECHTMSNCT06451835

Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation Using Vocal Biomarkers

An observational study of Major Depressive Disorder, run by GCS CIPS at 9 sites in France.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial summary

Voice recordings taken prior to the start of repetitive transcranial magnetic stimulation (rTMS) therapy will be used to develop a predictive model of treatment response using machine learning for patients with major depressive disorders (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 (rTMS)
Type of treatment: Medical device
How many people: 156 participants
Where: 9 sitesFrance
Study dates: 13 Jun 2024to 15 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: The patients recruited will be patients admitted as outpatients to treat MDD through a rTMS treatment in one of the 9 investigation centers.

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 EDC (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
Pathology altering phonation based on the perception of the investigator
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.

City, postcode or hospital

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

Other trials in France

About this study

Official title: Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder Using Vocal Biomarkers

Read the detailed description

The objective of this study is to investigate whether voice biomarkers taken prior to the start of rTMS can predict the response to a 30-session course of rTMS in patients with 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 commencement of the rTMS course, patients will need to complete several questionnaires. Before the first session, voice tests will be recorded using the Callyope application. Patients will answer questionnaires and assess voice tests weekly and after the final rTMS session to track the progression of depressive symptoms.

Conditions: Major Depressive Disorder
Being tested: repetitive transcranial magnetic stimulation (rTMS)
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 stimulation (rTMS)Device
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 groups in NCT06451835
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 (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the curve of the model predicting response to rTMS treatment
Area under the curve of the model predicting response to rTMS treatment, objectified by a 50% reduction in MADRS depression score, trained from vocal biomarkers recorded before rTMS treatment.
Measured: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)

Secondary outcomes (8)

Area under the curve of the rTMS remission prediction model
Area under the curve of the rTMS remission prediction model, objectified by a post-course MADRS score lower than 10, trained from vocal biomarkers recorded before the rTMS course.
Measured: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Area under the curve of the prediction model of the self-assessed response to the rTMS course
Area under the curve of the prediction model of the self-assessed response to the rTMS course, objectified by a 50% reduction in PHQ-9 depression score, trained from the vocal biomarkers recorded before the rTMS course.
Measured: 6 weeks : before the first session of rTMS (vocal samples) and each week during the rTMS treatment (PHQ-9 score)
Area under the curve of the prediction model of the response to the rTMS course, trained with the addition of weekly recorded voice samples.
Area under the curve of the prediction model of the response to the rTMS course, trained with the addition in the initial model of vocal biomarkers recorded each week of the rTMS course.
Measured: 6 weeks : weekly
Area under the curve of the model predicting the response to rTMS treatment, trained with the addition of clinical indicators
Area under the curve of the model predicting the response to rTMS treatment, trained with the addition in the initial model of clinical indicators other than depression.
Measured: 6 weeks : before the first session of rTMS (vocal samples) and before and after or weekly (clinical indicators)
Comparison between the scores predicted by the model and the actual scores obtained on the different questionnaires assessed.
Coefficients of determination R² and average absolute errors between the scores predicted by the model and the actual scores obtained on the different PHQ-9, GAD-7, IADL, AIS and MAP-SR questionnaires.
Measured: 6 weeks : before the first session of rTMS (vocal samples) and before and after the treatment (questionnaires)
Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.
Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.
Measured: 6 weeks : Before and after rTMS treatment
Risk and coverage of the different prediction models obtained.
Risk and coverage of the different prediction models obtained.
Measured: 6 weeks : After rTMS treatment
Comparison of the prediction models obtained with or without the use of advanced data encryption algorithms.
Comparison of the areas under the curve of the different prediction models obtained with or without the use of advanced data encryption algorithms.
Measured: 6 weeks : After rTMS treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202415 Jun 2025

First posted11 Jun 2024
Study start13 Jun 2024
Primary completion15 Apr 2025 (estimated)
Study completion15 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: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06451835
Sponsor's protocol ID: SPEECHTMS
Acronym: SPEECHTMS
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

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: Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder Using Vocal Biomarkers
ClinicalTrials.gov ID: NCT06451835
Acronym / sponsor ID: SPEECHTMS / SPEECHTMS
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: 156 participants (estimated)
Lead sponsor: GCS CIPSUniversity, hospital or other
Collaborators: Callyope
Study start: 13 Jun 2024 (actual)
Primary completion: 15 Apr 2025 (estimated)
Study completion: 15 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.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with MDD	–	Device: repetitive transcranial magnetic stimulation (rTMS)Patients 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: The patients recruited will be patients admitted as outpatients to treat MDD through a rTMS treatment in one of the 9 investigation centers.

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 stimulation (rTMS)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).	Device	Patients with MDD

Primary outcome

Area under the curve of the model predicting response to rTMS treatment
Time frame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Area under the curve of the model predicting response to rTMS treatment, objectified by a 50% reduction in MADRS depression score, trained from vocal biomarkers recorded before rTMS treatment.

8 secondary outcomes

Area under the curve of the rTMS remission prediction model
Time frame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)
Area under the curve of the prediction model of the self-assessed response to the rTMS course
Time frame: 6 weeks : before the first session of rTMS (vocal samples) and each week during the rTMS treatment (PHQ-9 score)
Area under the curve of the prediction model of the response to the rTMS course, trained with the addition of weekly recorded voice samples.
Time frame: 6 weeks : weekly
Area under the curve of the model predicting the response to rTMS treatment, trained with the addition of clinical indicators
Time frame: 6 weeks : before the first session of rTMS (vocal samples) and before and after or weekly (clinical indicators)
Comparison between the scores predicted by the model and the actual scores obtained on the different questionnaires assessed.
Time frame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the treatment (questionnaires)
Area under the curve of the different prediction models obtained, starting from pre-trained models on healthy subject databases.
Time frame: 6 weeks : Before and after rTMS treatment
Risk and coverage of the different prediction models obtained.
Time frame: 6 weeks : After rTMS treatment
Comparison of the prediction models obtained with or without the use of advanced data encryption algorithms.
Time frame: 6 weeks : After rTMS treatment

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

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)

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?

Area under the curve of the model predicting response to rTMS treatment (time frame: 6 weeks : before the first session of rTMS (vocal samples) and before and after the rTMS treatment (MADRS score)). 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 NCT06451835.

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.