Status:
RECRUITING
Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment
Lead Sponsor:
Centre Hospitalier Rouffach
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
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 subsequen...
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 indic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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,
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05964192
Start Date
April 1 2024
End Date
June 30 2029
Last Update
February 14 2024
Active Locations (1)
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1
Centre Hospitalier Rouffach
Rouffach, Alsace, France, 68250