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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
294

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Psychothérapique de Nancy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Schizophrenia Prodromal

Clinical Trials on behavioral tasks

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings