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

NCT07446569 | Not Yet Recruiting

• 2 other identifiers: 2024-A02456-41RIPH 2024-04
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Early Psychosis; Schizophrenia Prodromal

Outcome Measures

Primary Outcomes (7)

• Contrast sensitivity task

  computerized contrast detection task

  Day 1 for healthy controls, Day 1-30 for patients

• Facial emotion recognition task

  computerized emotion recognition task

  Day 1 for healthy controls, Day 1-30 for patients

• Visual inference task

  Computerized visual inference task

  Day 1 for healthy controls, Day 1-30 for patients

• Tone matching task

  Computerized tone matching task

  Day 1 for healthy controls, Day 1-30 for patients

• Auditory emotion recognition task

  Computerized emotion recognition task

  Day 1 for healthy controls, Day 1-30 for patients

• ERG measure

  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

  Day 1

Secondary Outcomes (6)

• CAARMS assessment

  6 months follow up

• TAP Working Memory test

  Day 1

• fNART

  Day 1

• Tap attention test

  Day 1

• Visual Object and Space Perception Battery (VOSP)

  Day 1

Study Arms (1)

observational behavioral and electrophysiological assessments

EXPERIMENTAL

Behavioral: behavioral tasks; Device: Electroretinography; Diagnostic Test: Comprehensive Assessment of At Risk Mental States (CAARMS); Behavioral: Neuropsychological tests

Interventions

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.

observational behavioral and electrophysiological assessments

Electroretinography DEVICE

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

observational behavioral and electrophysiological assessments

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

observational behavioral and electrophysiological assessments

Neuropsychological tests BEHAVIORAL

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

observational behavioral and electrophysiological assessments

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (4)

Centre Hospitalier Le Vinatier

Bron, 69678, France

Location

Centre Psychothérapique de Nancy

Laxou, 54520, France

Location

Centre Hospitalier Alpes-Isère

Saint-Égrève, 38120, France

Location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizotypal Personality Disorder

Interventions

Electroretinography; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personality Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Vincent LAPRÉVOTE, PU.PH

  Centre Psychothérapique de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélissa FENOT

CONTACT

0383925267; Melissa.FENOT@cpn-laxou.com

Naoual MELLOUKI BENDIMRED, PhD

CONTACT

0383925267; unic@cpn-laxou.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

FR (4)