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NCT Number: NCT07446569

Perception and Integration of Sensory Information in the Early Stages of Psychosis

The goal of this observational study is to investigate the early sensory system in clinical high risk (CHR), first episode psychosis (FEP) individuals and heathly controls. The main questions it aims to answer are:

* Can anomalies in visual and auditory sensory processing serve as early markers of psychosis risk? * How are these sensory anomalies related to clinical symptom severity and emotional recognition deficits?

Researchers will compare CHR and PEP participants to healthy controls to see if sensory processing differences can help identify individuals at higher risk of developing psychosis.

Participants will:

* Complete behavioral tasks evaluating visual processing (contrast sensitivity, contour integration, facial emotion recognition, visual inference using Necker cubes) and auditory processing (tone-matching, auditory emotion recognition). A temporal perception component will also be assessed within the auditory and emotion recognition tasks, rather than as a separate task. * Undergo electrophysiological assessments of retinal function using flash stimulation to record retinal potentials (a-wave, b-wave, phNR, oscillatory potentials). * Provide demographic, clinical, and neuropsychological data during study visits. * For CHR participants, attend follow-up visits up to 6 months post initial assessments to evaluate psychotic symptom progression.

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Key information

Conditions

Early Psychosis Mental Disorders Personality Disorders Psychotic Disorders Schizophrenia Prodromal Schizophrenia Spectrum and Other Psychotic Disorders Schizotypal Personality Disorder

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Le Vinatier, Bron, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral tasks

Behavioral

All participants will undergo behavioral assessments of visual and auditory processing, including contrast sensitivity, facial emotion recognition, visual inference using Necker cubes, tone-matching, and auditory emotion recognition.

Electroretinography

Device

Participants will additionally undergo electrophysiological recordings of retinal function (a-wave, b-wave, phNR, oscillatory potentials) using flash stimulation.

Comprehensive Assessment of At Risk Mental States (CAARMS)

Diagnostic Test

All participants will be assessed using the CAARMS in order to evaluate their symptoms and classify them into either the CHR or FEP group

Neuropsychological tests

Behavioral

TAP attention and working memory test, fNART, VOSP, Verbal fluency test.

Primary outcomes

  1. Contrast sensitivity task

    Time frame: Day 1 for healthy controls, Day 1-30 for patients

    computerized contrast detection task

  2. Facial emotion recognition task

    Time frame: Day 1 for healthy controls, Day 1-30 for patients

    computerized emotion recognition task

  3. Visual inference task

    Time frame: Day 1 for healthy controls, Day 1-30 for patients

    Computerized visual inference task

  4. Tone matching task

    Time frame: Day 1 for healthy controls, Day 1-30 for patients

    Computerized tone matching task

  5. Auditory emotion recognition task

    Time frame: Day 1 for healthy controls, Day 1-30 for patients

    Computerized emotion recognition task

  6. ERG measure

    Time frame: Day 1 for healthy controls, Day 1-30 for patients

    amplitude and latency of the b-wave, a-wave, PhNR and oscillatory potentials

  7. CAARMS assessment

    Time frame: Day 1

Secondary outcomes

  1. CAARMS assessment

    Time frame: 6 months follow up

    Follow-up symptomatic assessment to evaluate the predictive power of sensory treatment (computerized tasks, ERG) for the risk of psychotic transition.

  2. TAP Working Memory test

    Time frame: Day 1

  3. fNART

    Time frame: Day 1

  4. Tap attention test

    Time frame: Day 1

  5. Visual Object and Space Perception Battery (VOSP)

    Time frame: Day 1

  6. Verbal fluency test

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Mélissa FENOT

CONTACT

[email protected]

0383925267

Naoual MELLOUKI BENDIMRED, PhD

CONTACT

[email protected]

0383925267 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: PRIOR-ePSY

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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