Early PsychosisPRIOR-ePSYNCT07446569
Perception and Integration of Sensory Information in the Early Stages of Psychosis
A study testing behavioral tasks, Electroretinography and Comprehensive Assessment of At Risk Mental States (CAARMS) in people with Early Psychosis and Schizophrenia Prodromal, run by Centre Psychothérapique de Nancy at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Psychosis, Schizophrenia Prodromal
- What is being tested?
- behavioral tasks, Electroretinography and Comprehensive Assessment of At Risk Mental States (CAARMS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Centre Hospitalier Le Vinatier
Bron, 69678
Frédéric HAESEBAERT, PU.PH, 04 37 91 55 55, Frederic.HAESEBAERT@ch-le-vinatier.fr
Frédéric HAESEBAERT, PU.PH
Centre Psychothérapique de Nancy
Laxou, 54520
Mélissa FENOT, 0383925267, Melissa.FENOT@cpn-laxou.com
Naoual MELLOUKI BENDIMRED, PhD, 0383925267 ext. 33, unic@cpn-laxou.com
Centre Hospitalier Alpes-Isère
Saint-Égrève, 38120
Clément DONDE, PU.PH, 04 76 56 42 56, cdondecoquelet@chu-grenoble.fr
Clément DONDE, PU.PH
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, 42270
ERIC FAKRA, PU.PH, 0477127840, Eric.Fakra@chu-st-etienne.fr
Eric FAKRA, PU.PH
About this study
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?
Read more
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
- Being tested
- behavioral tasks, Electroretinography, Comprehensive Assessment of At Risk Mental States (CAARMS), Neuropsychological tests
- Medical subject headings
- Psychotic Disorders, Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral tasksBehavioural
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.
ElectroretinographyDevice
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 testsBehavioural
TAP attention and working memory test, fNART, VOSP, Verbal fluency test.
| Study group | Role | What they receive |
|---|---|---|
| observational behavioral and electrophysiological assessments | Experimental | Not described Receives: Behavioral: behavioral tasks; Device: Electroretinography; Diagnostic Test: Comprehensive Assessment of At Risk Mental States (CAARMS); Behavioral: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity task
computerized contrast detection task
Measured: Day 1 for healthy controls, Day 1-30 for patients
Facial emotion recognition task
computerized emotion recognition task
Measured: Day 1 for healthy controls, Day 1-30 for patients
Visual inference task
Computerized visual inference task
Measured: Day 1 for healthy controls, Day 1-30 for patients
Tone matching task
Computerized tone matching task
Measured: Day 1 for healthy controls, Day 1-30 for patients
Auditory emotion recognition task
Computerized emotion recognition task
Measured: 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
Measured: Day 1 for healthy controls, Day 1-30 for patients
CAARMS assessment
Measured: Day 1
Secondary outcomes (6)
CAARMS assessment
Follow-up symptomatic assessment to evaluate the predictive power of sensory treatment (computerized tasks, ERG) for the risk of psychotic transition.
Measured: 6 months follow up
TAP Working Memory test
Measured: Day 1
fNART
Measured: Day 1
Tap attention test
Measured: Day 1
Visual Object and Space Perception Battery (VOSP)
Measured: Day 1
Verbal fluency test
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LAPRÉVOTE, PU.PH, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446569
- Sponsor's protocol ID
- 2024-A02456-41
- Other IDs
- RIPH 2024-04
- Acronym
- PRIOR-ePSY
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception and Integration of Sensory Information in the Early Stages of Psychosis
- ClinicalTrials.gov ID
- NCT07446569
- Acronym / sponsor ID
- PRIOR-ePSY / 2024-A02456-41
- Conditions
- Early Psychosis, Schizophrenia Prodromal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational behavioral and electrophysiological assessments | Experimental | Behavioral: behavioral tasks, Device: Electroretinography, Diagnostic Test: Comprehensive Assessment of At Risk Mental States (CAARMS), Behavioral: Neuropsychological tests |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral tasksAll 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. | Behavioural | observational behavioral and electrophysiological assessments |
| ElectroretinographyParticipants will additionally undergo electrophysiological recordings of retinal function (a-wave, b-wave, phNR, oscillatory potentials) using flash stimulation. | Device | observational behavioral and electrophysiological assessments |
| 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 | Diagnostic test | observational behavioral and electrophysiological assessments |
| Neuropsychological testsTAP attention and working memory test, fNART, VOSP, Verbal fluency test. | Behavioural | observational behavioral and electrophysiological assessments |
Primary outcome
Contrast sensitivity task
Time frame: Day 1 for healthy controls, Day 1-30 for patients
computerized contrast detection task
Facial emotion recognition task
Time frame: Day 1 for healthy controls, Day 1-30 for patients
computerized emotion recognition task
Visual inference task
Time frame: Day 1 for healthy controls, Day 1-30 for patients
Computerized visual inference task
Tone matching task
Time frame: Day 1 for healthy controls, Day 1-30 for patients
Computerized tone matching task
Auditory emotion recognition task
Time frame: Day 1 for healthy controls, Day 1-30 for patients
Computerized emotion recognition task
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
CAARMS assessment
Time frame: Day 1
6 secondary outcomes
CAARMS assessment
Time frame: 6 months follow up
TAP Working Memory test
Time frame: Day 1
fNART
Time frame: Day 1
Tap attention test
Time frame: Day 1
Visual Object and Space Perception Battery (VOSP)
Time frame: Day 1
Verbal fluency test
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent LAPRÉVOTE, PU.PH principal investigator
Centre Psychothérapique de Nancy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral tasks, Electroretinography and Comprehensive Assessment of At Risk Mental States (CAARMS) in people with Early Psychosis and Schizophrenia Prodromal, run by Centre Psychothérapique de Nancy at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélissa FENOT (0383925267, Melissa.FENOT@cpn-laxou.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast sensitivity task (time frame: Day 1 for healthy controls, Day 1-30 for patients). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.