Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT05964192
Eligibility Criteria:
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 inclusionâ„ 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05964192
Study Brief:
Protocol Section:
NCT05964192