Perception and Integration of Sensory Information in the Early Stages of Psychosis (PRIOR-ePSY)

February 26, 2026 updated by: Centre Psychothérapique de Nancy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Naoual MELLOUKI BENDIMRED, PhD
  • Phone Number: 33 0383925267
  • Email: unic@cpn-laxou.com

Study Locations

  • France
      • Bron, France, 69678
        • Centre Hospitalier le Vinatier
        • Contact:
        • Principal Investigator:
          • Frédéric HAESEBAERT, PU.PH
      • Laxou, France, 54520
        • Centre Psychothérapique de Nancy
        • Contact:
        • Contact:
        • Principal Investigator:
          • vincent LAPREVOTE, PU.PH
        • Sub-Investigator:
          • florent BERNARDIN, PhD
      • Saint-Priest-en-Jarez, France, 42270
        • Centre Hospitalier Universitaire de Saint Etienne
        • Contact:
        • Principal Investigator:
          • Eric FAKRA, PU.PH
      • Saint-Égrève, France, 38120
        • Centre Hospitalier Alpes-Isère
        • Contact:
        • Principal Investigator:
          • Clément DONDE, PU.PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: observational behavioral and electrophysiological assessments
Behavioral: behavioral tasks
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.
Device: Electroretinography
Participants will additionally undergo electrophysiological recordings of retinal function (a-wave, b-wave, phNR, oscillatory potentials) using flash stimulation.
Diagnostic test: Comprehensive Assessment of At Risk Mental States (CAARMS)
All participants will be assessed using the CAARMS in order to evaluate their symptoms and classify them into either the CHR or FEP group
Behavioral: Neuropsychological tests
TAP attention and working memory test, fNART, VOSP, Verbal fluency test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast sensitivity task
Time Frame: Day 1 for healthy controls, Day 1-30 for patients
computerized contrast detection task
Day 1 for healthy controls, Day 1-30 for patients
Facial emotion recognition task
Time Frame: Day 1 for healthy controls, Day 1-30 for patients
computerized emotion recognition task
Day 1 for healthy controls, Day 1-30 for patients
Visual inference task
Time Frame: Day 1 for healthy controls, Day 1-30 for patients
Computerized visual inference task
Day 1 for healthy controls, Day 1-30 for patients
Tone matching task
Time Frame: Day 1 for healthy controls, Day 1-30 for patients
Computerized tone matching task
Day 1 for healthy controls, Day 1-30 for patients
Auditory emotion recognition task
Time Frame: Day 1 for healthy controls, Day 1-30 for patients
Computerized emotion recognition task
Day 1 for healthy controls, Day 1-30 for patients
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
Day 1 for healthy controls, Day 1-30 for patients
CAARMS assessment
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months follow up
TAP Working Memory test
Time Frame: Day 1
Day 1
fNART
Time Frame: Day 1
Day 1
Tap attention test
Time Frame: Day 1
Day 1
Visual Object and Space Perception Battery (VOSP)
Time Frame: Day 1
Day 1
Verbal fluency test
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Psychothérapique de Nancy

Collaborators

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

Investigators

  • Principal Investigator: Vincent Laprevote, PU.PH, Centre Psychothérapique de Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A02456-41
  • RIPH 2024-04 (Other Identifier: centre psychothérapique de Nancy)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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