Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964192
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-07-17
Brief Title:
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation rTMS Treatment
Sponsor:
Centre Hospitalier Rouffach
Organization:
Centre Hospitalier Rouffach
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endo-rTMS
Brief 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
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 ie 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 respondernon-responder status to rTMS-TBS
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 ie 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 respondernon-responder status to rTMS-TBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None