SchizophreniaNCT03788811
ERG Components in Schizophrenia and Bipolar Disorder Type I
An observational study of Schizophrenia and Bipolar I Disorder, run by diaMentis Inc. at 19 sites in 3 countries.
Trial summary
This study will further assess ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as Medical Device, SaMD) to support the diagnosis of… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder
- What is being tested?
- ERG assessment (RSPA)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 5 Jul 2018to 31 Dec 2026
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in a diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT); and control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria.
Who may be able to join
- Able to give written informed consent;
- 18 to 50 years old;
- Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in a diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT);
- Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria.
Who cannot join
- Control subjects taking antipsychotic drugs (other prescription medicines are allowed);
- Control subjects with a first-degree relative with SZ, BP, other psychotic disorder or recurrent major depressive disorder;
- Patient currently in an acute inpatient unit and not stable (i.e. experiencing an acute exacerbation of psychosis or mania);
- Diagnosed dementia, Parkinson's disease, autism or other pervasive developmental disorders or seizure disorders (such as epilepsy);
- Substance use disorder within the last 6 months;
- Any known diagnosis of ophthalmological abnormalities, such as diabetic retinopathy, glaucoma, change in intraocular pressure, macular degeneration, other retinal pathologies, congenital color vision deficiencies, strabismus or cataract;
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- Any person contra-indicated for an ERG test, including active corneal or conjunctival disease (e.g. pink eye or conjunctivitis), infection or a ruptured globe;
- Subjects in recovery phase following cataract surgery or post LASIK refractive surgery or trabeculectomy or any surgical/laser intervention, suspected penetrating ocular injury, ocular prosthesis or severe photophobia;
- Any person unable to or unwilling to participate in a psychiatric evaluation or ERG testing, including, in the clinical judgment of the Principal investigator, subjects with cognitive impairment that compromises their ability to participate meaningfully in a SCID-5-CT interview.
- Any subject during the course of the study that is pregnant or intends on becoming pregnant and/or receives or intends to receive fertility treatments. Subjects becoming pregnant during study will be excluded.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States11 sites
McLean Hospital
Belmont, Massachusetts, 02478
Collaborative Neuroscience Research LLC
Garden Grove, California, 92845
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
University Hills Clinical Research
Irving, Texas, 75062
Segal trials West Broward Outpatient Site
Lauderhill, Florida, 33319
Synergy San Diego
Lemon Grove, California, 91945
Segal Trials Miami Lakes Medical Research
Miami Lakes, Florida, 33016
Rutgers University Behavioral HealthCare
Piscataway, New Jersey, 08854
University of Rochester Medical Center
Rochester, New York, 14642
Richmond Behavioral Associates
Staten Island, New York, 10314
Collaborative Neuroscience Research LLC
Torrance, California, 90502
Canada5 sites
Queen's University
Kingston, Ontario, K7L 3N6
Institut Universitaire en Santé Mentale de Montréal
Montreal, Quebec, H1N 3M5
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
CISSS-CA Hôpital de Saint-Georges
Saint-Georges, Quebec, G5Y 4T8
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H4
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
Barwon Health University Hospital
Geelong, Victoria, 3220
Albert Road Clinic
Melbourne, Victoria, 3004
About this study
Official title: Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I
This study will further assess ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I. They involve the processing and analysis of specific retinal biosignatures (RSPA) with the support of statistical and mathematical modelling processes e.g. machine learning and statistical learning.
Read the detailed description
The technology under development by diaMentis is defined as a Software as a Medical Device (SaMD); it will be used in combination with an electroretinogram (ERG). This study will be performed using three different ERG devices, currently marketed and cleared by the health authorities (Espion, UTAS and RETeval) to support the analytical, scientific and performance validity of the SaMD.
Anomalies detected by ERG provide an objective measure that may reflect specific underlying dysfunctions in patients and thus hold promise to confirm relevant biosignatures in psychiatric disorders. Significant differences between patients with SZ, BPI and control subjects have been found despite confounding factors; this trial is required to better define the impact of patient characteristics on ERG features with a potential to refine the interpretation of results.
This is a multicenter study. Three hundred subjects will be enrolled into three groups: 100 SZ patients, 100 BPI patients and 100 control subjects (healthy volunteers).
The primary objective is to further characterize the ERG components in SZ and BPI patients in order to develop prediction models that discriminate each pathology.
The secondary objectives are the evaluation of the repeatability and reproducibility of the analysis of the ERG components in control subjects, the assessment of the reliability of ERG prediction score for patients following a repeat test, and the evaluation of the impact of different ERG devices on the data generated and the prediction models.
- Conditions
- Schizophrenia, Bipolar I Disorder
- Being tested
- ERG assessment (RSPA)
- Keywords
- Retinal Signal, Schizophrenia, Bipolar I Disorder, Support to diagnostic, ERG, Mental Disorder
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERG assessment (RSPA)Device
Processing and analysis of retinal signals
| Study group | Role | What they receive |
|---|---|---|
| Control subjects | Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria. Receives: Device: ERG assessment (RSPA) | |
| Patients with schizophrenia (SZ) | Patient with a diagnosis of schizophrenia for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT). Receives: Device: ERG assessment (RSPA) | |
| Patients with bipolar disorder Type I (BP1) | Patient with a diagnosis of bipolar disorder Type 1 for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT). Receives: Device: ERG assessment (RSPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in ERG components vs control ERG with full-field ERG stimulation conditions.
ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 100 msec post stimulation.
Measured: Three ERG assessments within 6 weeks.
Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.
ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 250 msec post stimulation.
Measured: Three ERG assessments within 6 weeks.
Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.
ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 300 msec post stimulation.
Measured: Three ERG assessments within 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start5 Jul 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- diaMentis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claude Hariton, PhD, DSc, Study director, diaMentis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788811
- Sponsor's protocol ID
- dM/CL-01
- Status last verified
- Aug 2025
- First submitted
- 20 Dec 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I
- ClinicalTrials.gov ID
- NCT03788811
- Acronym / sponsor ID
- dM/CL-01
- Conditions
- Schizophrenia, Bipolar I Disorder
- Keywords
- Retinal Signal, Schizophrenia, Bipolar I Disorder, Support to diagnostic, ERG, Mental Disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- diaMentis Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Dec 2018 (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.
This study will further assess ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test (classified as a Software as Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I. They involve the processing and analysis of specific retinal biosignatures (RSPA) with the support of statistical and mathematical modelling processes e.g. machine learning and statistical learning.
Detailed description
The technology under development by diaMentis is defined as a Software as a Medical Device (SaMD); it will be used in combination with an electroretinogram (ERG). This study will be performed using three different ERG devices, currently marketed and cleared by the health authorities (Espion, UTAS and RETeval) to support the analytical, scientific and performance validity of the SaMD.
Anomalies detected by ERG provide an objective measure that may reflect specific underlying dysfunctions in patients and thus hold promise to confirm relevant biosignatures in psychiatric disorders. Significant differences between patients with SZ, BPI and control subjects have been found despite confounding factors; this trial is required to better define the impact of patient characteristics on ERG features with a potential to refine the interpretation of results.
This is a multicenter study. Three hundred subjects will be enrolled into three groups: 100 SZ patients, 100 BPI patients and 100 control subjects (healthy volunteers).
The primary objective is to further characterize the ERG components in SZ and BPI patients in order to develop prediction models that discriminate each pathology.
The secondary objectives are the evaluation of the repeatability and reproducibility of the analysis of the ERG components in control subjects, the assessment of the reliability of ERG prediction score for patients following a repeat test, and the evaluation of the impact of different ERG devices on the data generated and the prediction models.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control subjects | – | Device: ERG assessment (RSPA)Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria. |
| Patients with schizophrenia (SZ) | – | Device: ERG assessment (RSPA)Patient with a diagnosis of schizophrenia for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT). |
| Patients with bipolar disorder Type I (BP1) | – | Device: ERG assessment (RSPA)Patient with a diagnosis of bipolar disorder Type 1 for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in a diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT); and control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria.
Key inclusion criteria (4 listed)
- Able to give written informed consent;
- 18 to 50 years old;
- Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in a diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT);
- Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria.
Key exclusion criteria (10 listed)
- Control subjects taking antipsychotic drugs (other prescription medicines are allowed);
- Control subjects with a first-degree relative with SZ, BP, other psychotic disorder or recurrent major depressive disorder;
- Patient currently in an acute inpatient unit and not stable (i.e. experiencing an acute exacerbation of psychosis or mania);
- Diagnosed dementia, Parkinson's disease, autism or other pervasive developmental disorders or seizure disorders (such as epilepsy);
- Substance use disorder within the last 6 months;
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 |
|---|---|---|
| ERG assessment (RSPA)Processing and analysis of retinal signals | Device | Control subjects, Patients with bipolar disorder Type I (BP1), Patients with schizophrenia (SZ) |
Primary outcome
Differences in ERG components vs control ERG with full-field ERG stimulation conditions.
Time frame: Three ERG assessments within 6 weeks.
ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 100 msec post stimulation.
Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.
Time frame: Three ERG assessments within 6 weeks.
ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 250 msec post stimulation.
Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.
Time frame: Three ERG assessments within 6 weeks.
ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 300 msec post stimulation.
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 22 Aug 2025.
- 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.
Claude Hariton, PhD, DSc study director
diaMentis Inc.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar I Disorder, run by diaMentis Inc. at 19 sites in 3 countries.
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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada, Australia. 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?
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?
Differences in ERG components vs control ERG with full-field ERG stimulation conditions. (time frame: Three ERG assessments within 6 weeks.). The study lists 3 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 22 Aug 2025.