ERG assessment (RSPA): Processing and analysis of retinal signals
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
* 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.
Primary outcome measure(s)
Differences in ERG components vs control ERG with full-field ERG stimulation conditions. — 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. — 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. — 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.
Trial sites (19)
Facility
City
Region
Status
Collaborative Neuroscience Research LLC
Garden Grove
California
Synergy San Diego
Lemon Grove
California
Collaborative Neuroscience Research LLC
Torrance
California
Segal trials West Broward Outpatient Site
Lauderhill
Florida
Segal Trials Miami Lakes Medical Research
Miami Lakes
Florida
McLean Hospital
Belmont
Massachusetts
Rutgers University Behavioral HealthCare
Piscataway
New Jersey
The Zucker Hillside Hospital
Glen Oaks
New York
University of Rochester Medical Center
Rochester
New York
Richmond Behavioral Associates
Staten Island
New York
University Hills Clinical Research
Irving
Texas
Monash Medical Centre
Clayton
Victoria
Barwon Health University Hospital
Geelong
Victoria
Albert Road Clinic
Melbourne
Victoria
Queen's University
Kingston
Ontario
Centre for Addiction and Mental Health (CAMH)
Toronto
Ontario
Institut Universitaire en Santé Mentale de Montréal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.