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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04106102
Eligibility Criteria:
Inclusion Criteria:
* Presenting an obsessive-compulsive disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders 5, evolving for at least two years
* Of significant clinical intensity: Yale-Brown's obsession-compulsion scale ≥ 16/40 continuously over the last 6 months. This criteria of persistent severity over the last 6 months will be explored by an in-depth clinical interview at the inclusion visit (Baseline BL)
* Resistant despite treatment with: 2 serotonergic antidepressants, each received for at least 8 weeks, at the maximum recommended or tolerated dosage AND behavioural and cognitive therapy for at least 6 months
* Drug treatment unchanged for at least 12 weeks
Exclusion Criteria:
* Patient with psychotic disorder, bipolar mood disorder, substance abuse or dependence (excluding tobacco)
* Patient at risk of suicide (score ≥ 2 on item 10 of the Montgomery-Åsberg depression rating scale)
* Contraindications to the practice of transcranial direct stimulation : history of cerebral pathology, intracranial hypertension, neurosurgery, cephalic metal implant, pacemaker
* Unbalanced epilepsy
* Previous use of transcranial direct stimulation (problem of maintaining the integrity of the blind procedure)
* Pregnancy or breastfeeding in progress, woman in a state of procreation without effective contraception (a urine pregnancy test will be performed)
* Scalp skin pathology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04106102
Study Brief:
Protocol Section:
NCT04106102