Prodromal SchizophreniaREVIPSYNCT05167396
REtinal and VIsual Cortical Response in Early PSYchosis
A study testing Retinaute (BioSerenity), EEG Headset 64 electrodes (BioSemi) and MonPackOne (Metrovision) in people with Prodromal Schizophrenia and Psychotic Episode, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial summary
The purpose of the REVIPSY study is to measure retinal and the visual cortical electrophysiological responses in situations at risk of psychosis in patients who have experienced a first psychotic episode. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Prodromal Schizophrenia, Psychotic Episode, Prodromal Symptoms
- What is being tested?
- Retinaute (BioSerenity), EEG Headset 64 electrodes (BioSemi) and MonPackOne (Metrovision)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusion Criteria:
- All groups Age and gender matching Age between 18 and 40 Enrolled in a social security plan Normal or corrected-to-normal visual acuity verified by Monoyer test In women of childbearing age: negative urine pregnancy test at the inclusion visit Person who has received and understood prior information about the study Person who has given free and informed written consent prior to any participation in the study
- Healthy control group (HC; n=30) Met "all groups" criteria No current disorders as assessed by the MINI global assessment No lifetime (hypo)manic episodes or psychotic disorders and current No current or past disorders by CAARMS assessment No current disorders according to ICD-10 criteria No positive family history (parents/first degree) for affective affective, non-affective psychoses or major affective disorders No regular use (more than 3 psychotropic medications: benzodiazepines, hypnotics,antidepressants, antipsychotics or mood regulators or psychostimulants) during the past last 12 months
- High clinical risk group for psychosis (CHRP; n=30) Met "all groups" criteria, Assessment at CAARMS:
- Attenuated positive symptoms (APS)
- OR Brief Intermittent Psychotic Symptoms (BIPS)
- OR Attenuated psychosis of sub-laminar frequency
- OR sub-laminar attenuated psychosis Antipsychotic treatment with a cumulative dose of equivalent chlorpromazine <2500mg lifetime (1)
- First Episode Psychosis (FEP; n=30) All-group criteria met CAARMS assessment: Psychosis/antipsychotic treatment threshold treatment threshold achieved at CAARMS Antipsychotic treatment with a cumulative dose of equivalent chlorpromazine <2500mg lifetime (1)
- Exclusion Criteria (all groups):
Impairment of the subject that makes it difficult or impossible to participate in the or comprehension of the information provided to him/her
Dyslexia
Substance use disorder according to CIM-10
Neurological history including progressive neurological pathology
Progressive retinal disease
Chronic glaucoma
Ophthalmologic pathology affecting visual acuity
Current ocular infection
Major under guardianship, curatorship or safeguard of justice
Pregnant or breastfeeding women
Persons in a life-threatening emergency situation
Result of the preliminary medical examination incompatible with the research
Patient presenting a suicidal risk.
Criteria incompatible with the use of the Retinaute:
- Allergy to silver
- Known or suspected allergy to any of the following components: polyamide, polyester, elastane, latex, rubber, silicone, or any synthetic material as well as to cotton in case the device is used without the device is used without a protective head covering
- Sensory disorders making the patient insensitive to pain on the skin.
- Behavioral problems making the patient extremely agitation or aggression.
- Mental disorders incompatible with the use of the device.
- Seizure disorder.
- Open wound in an area covered or wrapped by the device.
- User at high risk of contagion.
- Wearing an implantable medical device (e.g. pacemaker)
- Pregnant women, women in labor or nursing mothers.
- Allergy or skin sensitivity to one of the components of the cream Elefix or equivalent on the market: coconut oil, egg oil, propylene glycol egg oil, propylene glycol, glycerin, lanolin...
- Allergy or skin sensitivity to one of the components of the cream NuPrep or market equivalent
Participation in another interventional study (exclusion period included)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the REVIPSY study is to measure retinal and the visual cortical electrophysiological responses in situations at risk of psychosis in patients who have experienced a first psychotic episode. A perspective of this project will be to create new electrophysiological biomarkers predictive of the risk of conversion to psychosis
Read the detailed description
The severity of psychotic disorders and their disabling potential in young patients represent a major public health problem. These populations are affected by high-level cognitive disorders associated with highly integrative functions. However, there is increasing evidence of lower-level impairments, including vision. Indeed, the literature reports electrophysiological abnormalities at the retinal level, reflected by an alteration of the signal transmission in the retinal ganglion cells (RGC), photoreceptors and bipolar cells. At the cortical level, numerous studies report electrophysiological abnormalities associated with the activity of the primary visual areas. These both electrophysiological measurements have the advantage of being objective, reliable and reproducible, thus leading to new research perspectives concerning the link between retinal and cortical measures in psychosis. These measures could also be interesting for the detection of the risk of conversion to psychosis, before it develops.
The transition to a state of psychosis is in fact marked by the appearance of symptoms, which can occur several years before the diagnosis and impact the duration of the untreated psychosis. Thus, the notion of a clinical state at high risk of psychosis (CHRP) defines a population of patients said to be at risk of psychosis. These symptoms precede the occurrence of the first psychotic episode (FEP), indicating the clear transition to psychotic illness. The questions that arise at the present time concerned the early detection and intervention of psychosis during this prodromal phase. This detection could be done via electrophysiological measures associated to the visual processing, but also via measures of neuropsychological evaluations and behavioral measures.
That is why, a study on retinal and visual cortical alterations coupled with neuropsychological assessments and behavioral measures in populations at risk of populations at risk of CHRP psychosis and in FEP would potentially reveal predictive biomarkers of the pathology. Such a project could lead to the development of retino-cortical biomarkers in mental health and will eventually lead to to create ultra-portable, reliable and routinely usable measurement devices for the early detection of psychosis in clinic.
Main objective: To measure retinal and visual cortical electrophysiological responses in clinical subjects at high risk of psychosis (CHRP) in comparison with first-episode psychotic patients (FEP) and healthy controls (CS)
Secondary objective(s) :
Compare ERG traces obtained from the "Retinaute" portable ERG device produced by the company BioSerenity with ERG traces obtained from a standard device ERG measurement device "MyPackOne" produced by the company Metrovision among healthy controls
To measure performance on neuropsychological tests in clinical subjects at high risk of psychosis (CHRP) compared to patients with a first episode of psychosis (FEP)
Measuring temporal prediction in tactile modality (unimodal) with a motor task, in clinical subjects at high risk of psychosis (CHRP) in comparison with first-episode patients (FEP) and healthy controls (CS)
Measuring temporal prediction in visual and tactile (multimodal) modalities/Measuring temporal prediction in visual modality (unimodal) with a classical perceptual task in clinical subjects at high risk of psychosis (CHRP) in comparison with patients with a first psychotic episode with a first episode of psychosis (FEP) and healthy controls (CS)
To compare the sensitivity of behavioural and EEG measures to the prediction of tactile vs. visual stimuli, and multimodal vs. unimodal
- Being tested
- Retinaute (BioSerenity), EEG Headset 64 electrodes (BioSemi), MonPackOne (Metrovision)
- Keywords
- Electrophysiology, Vision, Retina, Visual Cortex, Early psychosis, ERG, EEG
- Medical subject headings
- Schizotypal Personality Disorder, Prodromal Symptoms, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinaute (BioSerenity)Device
Wearable device in the form of a virtual reality headset for the recording of electrophysiological measurements such as electroretinogram (ERG) and electrocenphalogram (EEG), ISCEV standards
EEG Headset 64 electrodes (BioSemi)Device
EEG headset with 64 electrodes for the recording of visual cortical electrophysiological signals
MonPackOne (Metrovision)Device
Standard device for the recording of electroretinography (ERG) measurements, ISCEV standards
WARNING : Device used only in 3 healthy controls to address the secondary objective
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls (HC) | Experimental | n=90 Receives: Device: Retinaute (BioSerenity); Device: EEG Headset 64 electrodes (BioSemi); Device: MonPackOne (Metrovision) |
| Clinical High Risk of Psychosis (CHRP) | Experimental | n=30 Receives: Device: Retinaute (BioSerenity); Device: EEG Headset 64 electrodes (BioSemi) |
| First Episode Psychosis (FEP) | Experimental | n=30 Receives: Device: Retinaute (BioSerenity); Device: EEG Headset 64 electrodes (BioSemi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
N95 wave
Amplitude
Measured: Day1
a wave
Amplitude
Measured: Day1
b wave
Amplitude
Measured: Day1
P100 wave
Amplitude
Measured: Day1
Secondary outcomes (8)
Visual Object and Space Perception (VOSP)
Score
Measured: Day1
Verbal Fluency
Score
Measured: Day1
Working Memory
Score
Measured: Day1
Betarythm (EEG oscillatory responses)
Amplitude
Measured: Day1
Contingent Negative Variation (CNV)
Amplitude reaction time between a warning and a go signal as measured by electroencephalography (EEG)
Measured: Day1
CPT-AX (Continuous Performance Task version AX)
Score
Measured: Day1
fNART (French adaptation of National Adult Reading Test)
Score
Measured: Day1
TAP (Test of Attentional Performance)
Score
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start26 Jan 2022
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Why it stopped: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prodromal SchizophreniaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a cross-sectional, open, monocentric, non-randomized study applied in psychiatry and neuroscience. This study will include three groups of adults subject (\>18 years) * Patients with clinical high risk of psychosis (CHRP ; n=30) * Patients having experienced a first psychotic episode (FEP ; n=30) * Healthy Controls (HC ; n=30)
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Collaborators
- BioSerenity, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Vincent LAPRÉVOTE, Pr. MD PhD, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167396
- Sponsor's protocol ID
- RIPH 2021-04
- Other IDs
- n° IDRCB 2021-A01700-41
- Acronym
- REVIPSY
- Status last verified
- Aug 2024
- First submitted
- 4 Oct 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laprevote V, Heitz U, Di Patrizio P, Studerus E, Ligier F, Schwitzer T, Schwan R, Riecher-Rossler A. [Why and how to treat psychosis earlier?]. Presse Med. 2016 Nov;45(11):992-1000. doi: 10.1016/j.lpm.2016.07.011. Epub 2016 Aug 21. French.
PubMed 27554461Demmin DL, Davis Q, Roche M, Silverstein SM. Electroretinographic anomalies in schizophrenia. J Abnorm Psychol. 2018 May;127(4):417-428. doi: 10.1037/abn0000347.
PubMed 29745706Moghimi P, Torres Jimenez N, McLoon LK, Netoff TI, Lee MS, MacDonald A 3rd, Miller RF. Electoretinographic evidence of retinal ganglion cell-dependent function in schizophrenia. Schizophr Res. 2020 May;219:34-46. doi: 10.1016/j.schres.2019.09.005. Epub 2019 Oct 12.
PubMed 31615740Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. [Retinal investigations in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature]. J Fr Ophtalmol. 2020 Sep;43(7):586-597. doi: 10.1016/j.jfo.2019.10.029. Epub 2020 Jul 4. French.
PubMed 32631695Butler PD, Martinez A, Foxe JJ, Kim D, Zemon V, Silipo G, Mahoney J, Shpaner M, Jalbrzikowski M, Javitt DC. Subcortical visual dysfunction in schizophrenia drives secondary cortical impairments. Brain. 2007 Feb;130(Pt 2):417-30. doi: 10.1093/brain/awl233. Epub 2006 Sep 19.
PubMed 16984902Knebel JF, Javitt DC, Murray MM. Impaired early visual response modulations to spatial information in chronic schizophrenia. Psychiatry Res. 2011 Sep 30;193(3):168-76. doi: 10.1016/j.pscychresns.2011.02.006. Epub 2011 Jul 20.
PubMed 21764264Kim DW, Shim M, Song MJ, Im CH, Lee SH. Early visual processing deficits in patients with schizophrenia during spatial frequency-dependent facial affect processing. Schizophr Res. 2015 Feb;161(2-3):314-21. doi: 10.1016/j.schres.2014.12.020. Epub 2014 Dec 29.
PubMed 25553978
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REtinal and VIsual Cortical Response in Early PSYchosis
- ClinicalTrials.gov ID
- NCT05167396
- Acronym / sponsor ID
- REVIPSY / RIPH 2021-04
- Keywords
- Electrophysiology, Vision, Retina, Visual Cortex, Early psychosis, ERG, EEG
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Collaborators
- BioSerenity, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 22 Dec 2021 (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 purpose of the REVIPSY study is to measure retinal and the visual cortical electrophysiological responses in situations at risk of psychosis in patients who have experienced a first psychotic episode. A perspective of this project will be to create new electrophysiological biomarkers predictive of the risk of conversion to psychosis
Detailed description
The severity of psychotic disorders and their disabling potential in young patients represent a major public health problem. These populations are affected by high-level cognitive disorders associated with highly integrative functions. However, there is increasing evidence of lower-level impairments, including vision. Indeed, the literature reports electrophysiological abnormalities at the retinal level, reflected by an alteration of the signal transmission in the retinal ganglion cells (RGC), photoreceptors and bipolar cells. At the cortical level, numerous studies report electrophysiological abnormalities associated with the activity of the primary visual areas. These both electrophysiological measurements have the advantage of being objective, reliable and reproducible, thus leading to new research perspectives concerning the link between retinal and cortical measures in psychosis. These measures could also be interesting for the detection of the risk of conversion to psychosis, before it develops.
The transition to a state of psychosis is in fact marked by the appearance of symptoms, which can occur several years before the diagnosis and impact the duration of the untreated psychosis. Thus, the notion of a clinical state at high risk of psychosis (CHRP) defines a population of patients said to be at risk of psychosis. These symptoms precede the occurrence of the first psychotic episode (FEP), indicating the clear transition to psychotic illness. The questions that arise at the present time concerned the early detection and intervention of psychosis during this prodromal phase. This detection could be done via electrophysiological measures associated to the visual processing, but also via measures of neuropsychological evaluations and behavioral measures.
That is why, a study on retinal and visual cortical alterations coupled with neuropsychological assessments and behavioral measures in populations at risk of populations at risk of CHRP psychosis and in FEP would potentially reveal predictive biomarkers of the pathology. Such a project could lead to the development of retino-cortical biomarkers in mental health and will eventually lead to to create ultra-portable, reliable and routinely usable measurement devices for the early detection of psychosis in clinic.
Main objective: To measure retinal and visual cortical electrophysiological responses in clinical subjects at high risk of psychosis (CHRP) in comparison with first-episode psychotic patients (FEP) and healthy controls (CS)
Secondary objective(s) :
Compare ERG traces obtained from the "Retinaute" portable ERG device produced by the company BioSerenity with ERG traces obtained from a standard device ERG measurement device "MyPackOne" produced by the company Metrovision among healthy controls
To measure performance on neuropsychological tests in clinical subjects at high risk of psychosis (CHRP) compared to patients with a first episode of psychosis (FEP)
Measuring temporal prediction in tactile modality (unimodal) with a motor task, in clinical subjects at high risk of psychosis (CHRP) in comparison with first-episode patients (FEP) and healthy controls (CS)
Measuring temporal prediction in visual and tactile (multimodal) modalities/Measuring temporal prediction in visual modality (unimodal) with a classical perceptual task in clinical subjects at high risk of psychosis (CHRP) in comparison with patients with a first psychotic episode with a first episode of psychosis (FEP) and healthy controls (CS)
To compare the sensitivity of behavioural and EEG measures to the prediction of tactile vs. visual stimuli, and multimodal vs. unimodal
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a cross-sectional, open, monocentric, non-randomized study applied in psychiatry and neuroscience. This study will include three groups of adults subject (>18 years) * Patients with clinical high risk of psychosis (CHRP ; n=30) * Patients having experienced a first psychotic episode (FEP ; n=30) * Healthy Controls (HC ; n=30)
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls (HC) | Experimental | Device: Retinaute (BioSerenity), Device: EEG Headset 64 electrodes (BioSemi), Device: MonPackOne (Metrovision)n=90 |
| Clinical High Risk of Psychosis (CHRP) | Experimental | Device: Retinaute (BioSerenity), Device: EEG Headset 64 electrodes (BioSemi)n=30 |
| First Episode Psychosis (FEP) | Experimental | Device: Retinaute (BioSerenity), Device: EEG Headset 64 electrodes (BioSemi)n=30 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Retinaute (BioSerenity)Wearable device in the form of a virtual reality headset for the recording of electrophysiological measurements such as electroretinogram (ERG) and electrocenphalogram (EEG), ISCEV standards | Device | Clinical High Risk of Psychosis (CHRP), First Episode Psychosis (FEP), Healthy Controls (HC) |
| EEG Headset 64 electrodes (BioSemi)EEG headset with 64 electrodes for the recording of visual cortical electrophysiological signals | Device | Clinical High Risk of Psychosis (CHRP), First Episode Psychosis (FEP), Healthy Controls (HC) |
| MonPackOne (Metrovision)Standard device for the recording of electroretinography (ERG) measurements, ISCEV standards WARNING : Device used only in 3 healthy controls to address the secondary objective | Device | Healthy Controls (HC) |
Primary outcome
N95 wave
Time frame: Day1
Amplitude
a wave
Time frame: Day1
Amplitude
b wave
Time frame: Day1
Amplitude
P100 wave
Time frame: Day1
Amplitude
8 secondary outcomes
Visual Object and Space Perception (VOSP)
Time frame: Day1
Verbal Fluency
Time frame: Day1
Working Memory
Time frame: Day1
Betarythm (EEG oscillatory responses)
Time frame: Day1
Contingent Negative Variation (CNV)
Time frame: Day1
CPT-AX (Continuous Performance Task version AX)
Time frame: Day1
fNART (French adaptation of National Adult Reading Test)
Time frame: Day1
TAP (Test of Attentional Performance)
Time frame: Day1
Results and safety
The study was stopped early (reason given: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 27554461Laprevote V, Heitz U, Di Patrizio P, Studerus E, Ligier F, Schwitzer T, Schwan R, Riecher-Rossler A. [Why and how to treat psychosis earlier?]. Presse Med. 2016 Nov;45(11):992-1000. doi: 10.1016/j.lpm.2016.07.011. Epub 2016 Aug 21. French.
- Background: PubMed 29745706Demmin DL, Davis Q, Roche M, Silverstein SM. Electroretinographic anomalies in schizophrenia. J Abnorm Psychol. 2018 May;127(4):417-428. doi: 10.1037/abn0000347.
- Background: PubMed 31615740Moghimi P, Torres Jimenez N, McLoon LK, Netoff TI, Lee MS, MacDonald A 3rd, Miller RF. Electoretinographic evidence of retinal ganglion cell-dependent function in schizophrenia. Schizophr Res. 2020 May;219:34-46. doi: 10.1016/j.schres.2019.09.005. Epub 2019 Oct 12.
- Background: PubMed 32631695Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. [Retinal investigations in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature]. J Fr Ophtalmol. 2020 Sep;43(7):586-597. doi: 10.1016/j.jfo.2019.10.029. Epub 2020 Jul 4. French.
- Background: PubMed 16984902Butler PD, Martinez A, Foxe JJ, Kim D, Zemon V, Silipo G, Mahoney J, Shpaner M, Jalbrzikowski M, Javitt DC. Subcortical visual dysfunction in schizophrenia drives secondary cortical impairments. Brain. 2007 Feb;130(Pt 2):417-30. doi: 10.1093/brain/awl233. Epub 2006 Sep 19.
- Background: PubMed 21764264Knebel JF, Javitt DC, Murray MM. Impaired early visual response modulations to spatial information in chronic schizophrenia. Psychiatry Res. 2011 Sep 30;193(3):168-76. doi: 10.1016/j.pscychresns.2011.02.006. Epub 2011 Jul 20.
- Background: PubMed 25553978Kim DW, Shim M, Song MJ, Im CH, Lee SH. Early visual processing deficits in patients with schizophrenia during spatial frequency-dependent facial affect processing. Schizophr Res. 2015 Feb;161(2-3):314-21. doi: 10.1016/j.schres.2014.12.020. Epub 2014 Dec 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vincent LAPRÉVOTE, Pr. MD PhD principal investigator
Centre Psychothérapique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinaute (BioSerenity), EEG Headset 64 electrodes (BioSemi) and MonPackOne (Metrovision) in people with Prodromal Schizophrenia and Psychotic Episode, run by Centre Psychothérapique de Nancy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Malfunctions of the Retinaute® but no adverse effects on participants. Study interrupted for BioSerenity to make technical corrections. Long immobilization of the device and conditions for reusing it not adapted to the continuation of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N95 wave (time frame: Day1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167396, which also lists 7 linked publications.
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 22 Aug 2024.