Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment

Major Depression Clinical Trial

— Endo-rTMS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964192
• Other study ID #: 2023-A00288-37
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Rouffach
• Contact: MIHAELA TOMSA
• Phone: +33 389787018
• Email: m.tomsa[@]ch-rouffach.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 least a 50% decrease in depression score after 20 sessions of rTMS-TBS.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2029
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;

2. Patient between the ages of 18 and 65 years;

3. Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale [HAMD-17] score at inclusion= 18) ;

4. Patient with written informed consent to participate in the study;

5. Patient enrolled in or receiving social security benefits.

Exclusion Criteria:

1. Patient with endocrinopathy ;

2. Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);

3. Patient with a contraindication to rTMS:

• cochlear implant,
• cardiac pacemaker,
• metal clips, stents or other electronic implants within one meter of the stimulation coil,
• intracranial hypertension,
• poorly balanced comitiality,
• in the case of well-balanced comitiality, a neurological consultation with electroencephalogram (EEG) is planned before including the patient;

4. Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);

5. Pregnant or lactating patient;

6. Patient under court protection or deprived of liberty;

7. Patient under guardianship/guardianship.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
France	Centre Hospitalier Rouffach	Rouffach	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Rouffach

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions)
Secondary	Hamilton Depression Scale (HAMD)	Functional remission will be defined by a HAMD score = 8 at the end of 20 sessions of rTMS-TBS	Through study completion, an average of 6 weeks
Secondary	Evolution of neuroendocrine parameters	Pre- and post-treatment difference in neuroendocrine test values	Through study completion, an average of 6 weeks
Secondary	Evolution of neuroendocrine parameters	Proportion of patients having normalized their tests at the end of the 20 sessions of rTMs.	Through study completion, an average of 6 weeks
Secondary	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.	Through study completion, an average of 6 weeks
Secondary	Predictive factors	Predictors of response to rTMS treatment (e.g., demographics)	Through study completion, an average of 6 weeks