Major DepressionEndo-rTMSNCT05964192
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Major Depression, run by Centre Hospitalier Rouffach at 1 site in France.
Trial summary
The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 30 Jun 2029
- 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 characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;
- Patient between the ages of 18 and 65 years;
- Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale [HAMD-17] score at inclusion≥ 18) ;
- Patient with written informed consent to participate in the study;
- Patient enrolled in or receiving social security benefits.
Who cannot join
- Patient with endocrinopathy ;
- Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);
- Patient with a contraindication to rTMS:
- cochlear implant,
- cardiac pacemaker,
- metal clips, stents or other electronic implants within one meter of the stimulation coil,
Show all 13Show fewer
- intracranial hypertension,
- poorly balanced comitiality,
- in the case of well-balanced comitiality, a neurological consultation with electroencephalogram (EEG) is planned before including the patient;
- Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
- Pregnant or lactating patient;
- Patient under court protection or deprived of liberty;
- Patient under guardianship/guardianship.
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 Rouffach
Rouffach, Alsace, 68250
Fabrice Duval, MD, 33389787018, f.duval@ch-rouffach.fr
Alexis Erb, MD, 33389787018, a.erb@ch-rouffach.fr
About this study
Official title: Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment : a Pilot Study in Major Depression (Endo-rTMS)
The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at least a 50% decrease in depression score after 20 sessions of rTMS-TBS.
Read the detailed description
Conduct of research :
This is a monocentric, non-randomized, open-label pilot study involving 50 male and female patients aged 18 to 65, hospitalized for major depression and presenting with an indication for treatment with repeated theta-burst transcranial magnetic stimulation (rTMS-TBS), i.e. a situation of therapeutic failure following 2 well-conducted antidepressant treatments.
At the end of the 20 rTMS-TBS sessions (one session per day, except weekends), the clinical response will be assessed by an investigator "blind" to the endocrine results. This response will be analyzed according to the status of neuroendocrine tests at inclusion (TRH-∆∆TSH and DST) and at the end of the study (for those who had one or more abnormal tests at inclusion and in whom the same tests were repeated at the end of the rTMS-TBS sessions).
During the inclusion visit, the patient and investigator sign the consent form, after double-checking the inclusion and non-inclusion criteria.
Immediately after the tenth rTMS session, an assessment of depression using the HAMD (17-item Hamilton Depression Scale) scale will be carried out by an independent psychiatrist, blind to the results of the neuroendocrine tests. This psychiatrist, who has already administered the HAMD at V0, will repeat the assessments at V1 and V2.
Immediately after the twentieth rTMS session, an assessment of depression using the HAMD scale will be carried out by an independent psychiatrist. This assessment will determine responder/non-responder status to rTMS-TBS.
- Conditions
- Major Depression
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Depression, clinical outcome, rTMS (repetitive transcranial magnetic stimulation), theta burst, TRH (thyreoliberin) test, DST (dexamethasone suppression test)
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Procedure or surgery
The theta burst stimulation (TBS) technique consists in administering bursts of transcranial magnetic stimulation (TMS) at very high frequency (50Hz) for 5 minutes (3 pulses of stimulation given at 50 hz; 10 bursts/1 s train; inter-train interval : 8 s; number of trains : 30; 100% resting motor threshold; number pulses/session : 900). Total number of sessions : 20 sessions (single daily session).
| Study group | Role | What they receive |
|---|---|---|
| Treatment resistant major depressed inpatients (TRDs) | Experimental | Not described Receives: Procedure: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item Hamilton Depression Scale (HAMD)
Clinical response will be defined by at least a 50% decrease in depression score at the end of the 20 rTMS-TBS sessions - measured by the 17-item Hamilton Depression Scale (HAMD) - compared to inclusion (Carrozzino et al, 2020). The predictive value of the TRH-∆∆TSH on the one hand, and the DST on the other, will be assessed using an ROC curve and its AUC (Area Under the Curve) calculation.
Measured: Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions)
Secondary outcomes (5)
Hamilton Depression Scale (HAMD)
Functional remission will be defined by a HAMD score ≤ 8 at the end of 20 sessions of rTMS-TBS
Measured: Through study completion, an average of 6 weeks
Evolution of neuroendocrine parameters
Pre- and post-treatment difference in neuroendocrine test values
Measured: Through study completion, an average of 6 weeks
Evolution of neuroendocrine parameters
Proportion of patients having normalized their tests at the end of the 20 sessions of rTMs.
Measured: Through study completion, an average of 6 weeks
Relationship of the therapeutic response with the evolution of neuroendocrine parameters
Proportion of responders/functional remission patients according to the normalization or not of neuroendocrine tests after rTMS-TBS treatment.
Measured: Through study completion, an average of 6 weeks
Predictive factors
Predictors of response to rTMS treatment (e.g., demographics)
Measured: Through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Apr 2024 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Rouffach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MIHAELA TOMSA, PhD, Principal investigator, CENTRE HOSPITALIER DE ROUFFACH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964192
- Sponsor's protocol ID
- 2023-A00288-37
- Acronym
- Endo-rTMS
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment : a Pilot Study in Major Depression (Endo-rTMS)
- ClinicalTrials.gov ID
- NCT05964192
- Acronym / sponsor ID
- Endo-rTMS / 2023-A00288-37
- Conditions
- Major Depression
- Keywords
- Depression, clinical outcome, rTMS (repetitive transcranial magnetic stimulation), theta burst, TRH (thyreoliberin) test, DST (dexamethasone suppression test)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier RouffachUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 Jul 2023 (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.
The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at least a 50% decrease in depression score after 20 sessions of rTMS-TBS.
Detailed description
Conduct of research :
This is a monocentric, non-randomized, open-label pilot study involving 50 male and female patients aged 18 to 65, hospitalized for major depression and presenting with an indication for treatment with repeated theta-burst transcranial magnetic stimulation (rTMS-TBS), i.e. a situation of therapeutic failure following 2 well-conducted antidepressant treatments.
At the end of the 20 rTMS-TBS sessions (one session per day, except weekends), the clinical response will be assessed by an investigator "blind" to the endocrine results. This response will be analyzed according to the status of neuroendocrine tests at inclusion (TRH-∆∆TSH and DST) and at the end of the study (for those who had one or more abnormal tests at inclusion and in whom the same tests were repeated at the end of the rTMS-TBS sessions).
During the inclusion visit, the patient and investigator sign the consent form, after double-checking the inclusion and non-inclusion criteria.
Immediately after the tenth rTMS session, an assessment of depression using the HAMD (17-item Hamilton Depression Scale) scale will be carried out by an independent psychiatrist, blind to the results of the neuroendocrine tests. This psychiatrist, who has already administered the HAMD at V0, will repeat the assessments at V1 and V2.
Immediately after the twentieth rTMS session, an assessment of depression using the HAMD scale will be carried out by an independent psychiatrist. This assessment will determine responder/non-responder status to rTMS-TBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment resistant major depressed inpatients (TRDs) | Experimental | Procedure: Repetitive transcranial magnetic stimulation (rTMS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;
- Patient between the ages of 18 and 65 years;
- Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale [HAMD-17] score at inclusion≥ 18) ;
- Patient with written informed consent to participate in the study;
- Patient enrolled in or receiving social security benefits.
Key exclusion criteria (13 listed)
- Patient with endocrinopathy ;
- Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);
- Patient with a contraindication to rTMS:
- Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
- Pregnant or lactating patient;
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)The theta burst stimulation (TBS) technique consists in administering bursts of transcranial magnetic stimulation (TMS) at very high frequency (50Hz) for 5 minutes (3 pulses of stimulation given at 50 hz; 10 bursts/1 s train; inter-train interval : 8 s; number of trains : 30; 100% resting motor threshold; number pulses/session : 900). Total number of sessions : 20 sessions (single daily session). | Procedure or surgery | Treatment resistant major depressed inpatients (TRDs) |
Primary outcome
17-item Hamilton Depression Scale (HAMD)
Time frame: Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions)
Clinical response will be defined by at least a 50% decrease in depression score at the end of the 20 rTMS-TBS sessions - measured by the 17-item Hamilton Depression Scale (HAMD) - compared to inclusion (Carrozzino et al, 2020). The predictive value of the TRH-∆∆TSH on the one hand, and the DST on the other, will be assessed using an ROC curve and its AUC (Area Under the Curve) calculation.
5 secondary outcomes
Hamilton Depression Scale (HAMD)
Time frame: Through study completion, an average of 6 weeks
Evolution of neuroendocrine parameters
Time frame: Through study completion, an average of 6 weeks
Evolution of neuroendocrine parameters
Time frame: Through study completion, an average of 6 weeks
Relationship of the therapeutic response with the evolution of neuroendocrine parameters
Time frame: Through study completion, an average of 6 weeks
Predictive factors
Time frame: Through study completion, an average of 6 weeks
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 14 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Major Depression
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.
MIHAELA TOMSA, PhD principal investigator
CENTRE HOSPITALIER DE ROUFFACH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Major Depression, run by Centre Hospitalier Rouffach 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 5 inclusion and 13 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 14 Feb 2024. 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 MIHAELA TOMSA (+33 389787018, m.tomsa@ch-rouffach.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-item Hamilton Depression Scale (HAMD) (time frame: Change from inclusion result at 6 weeks (after 20 rTMS-TBS 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 14 Feb 2024.