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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07446569
Eligibility Criteria:
Inclusion criteria:
All groups:
* Age between 18 and 30 years
* Normal or corrected-to-normal visual acuity
* Affiliated with or dependent on a social security health insurance plan
* Provided informed consent and co-signed the study consent form with the investigator
* Proficient in French
Control group (TEM) specific criteria:
* No current psychiatric disorder (DSM-IV Axis I), except anxiety disorders
* No lifetime history of (hypo)manic episodes or psychotic disorders
* No first-degree family history of schizophrenia spectrum disorders
* No regular use (more than one month continuously) in the past 6 months of the following medications: benzodiazepines, hypnotics, antidepressants, antipsychotics, mood stabilizers, or psychostimulants
Clinical High-Risk (CHR) group specific criteria:
-Meet CHR criteria according to CAARMS: Attenuated positive symptoms (APS) below clinical threshold in intensity or frequency OR Brief Limited Intermittent Psychotic Symptoms (SPLI) OR Genetic Risk
First-Episode Psychosis (PEP) group specific criteria:
-Meet PEP criteria according to CAARMS (psychosis threshold reached)
Exclusion criteria:
* Pregnant, postpartum, or breastfeeding women
* Individuals deprived of liberty by judicial or administrative decision
* Individuals in a life-threatening emergency
* Adults under legal protection measures
* Adults unable to provide consent and not under legal protection
* Impairment that makes participation in the study or understanding of information difficult or impossible
* Alcohol dependence (AUDIT score ≥12 for men, ≥11 for women)
* Current substance use disorder (DAST score \>6)
* Cannabis use disorder (CUDIT-R score ≥13)
* History of neurological disorders, including progressive neurological disease
* Progressive retinal disease
* Chronic glaucoma
* Ophthalmologic conditions affecting visual acuity
* Current eye infection
* Hearing disorders affecting auditory acuity
Criteria incompatible with the electroretinographic device:
* Presence of photosensitive epilepsy
* Allergy to components of the electrode gel
* Behavioral problems causing extreme agitation or aggression
* Eye or surrounding tissue lesions that may come into contact with the device
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT07446569
Study Brief:
Protocol Section:
NCT07446569