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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT03606850
Eligibility Criteria:
Inclusion criteria:
* major depressive episode (according to DSM 5 criteria). Severity of depressive episode assessed by Hamilton Depressive Rating Scale 21 items (HAMD-21) : score \> 15 (significant impairment), low suicide risk (score \< 2 on suicide item).
* Drug-naive patient (or antidepressant stopped for more than 3 months).
* Patient covered by security social system.
* Patient who is able to read and understand the information paper. Patient who is able to sign the consent.
* For women of childbearing age, effective method of contraception (estrogen-progestin contraceptive or intra-uterine device or tubal ligation) for more than 1 month (negative pregnancy test).
Exclusion criteria:
* Coprescription of psychoactive or neurological drugs known to alter cortical excitability
* Other psychiatric disorders (psychotic disorders, eating disorders).
* Change of antidepressive drug during the study.
* Abuse or addiction at other substances than nicotine or caffeine.
* Unsteady consumption of nicotine or caffeine.
* Dermatologic disease, dementia, medical history of seizure or epilepsy, brain tumor, metallic biomedical implants in brain.
* Ongoing treatment by magnetic or electric stimulation (for example : transcutaneous nerve stimulation or spinal cord stimulation).
* Women of childbearing age without effective contraception, pregnant or breastfeeding.
* Patient who was already included in a clinical trial within 30 days before the inclusion visit.
* Patient deprived of liberty and under guardianship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03606850
Study Brief:
Protocol Section:
NCT03606850