ERG Components in Schizophrenia and Bipolar Disorder Type I

Schizophrenia Clinical Trial

Official title:

Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03788811
• Other study ID #: dM/CL-01
• Status: Active, not recruiting
• Start date: July 5, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: diaMentis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar I Disorder
• Schizophrenia

Intervention

Device:
• ERG assessment (RSPA)
Processing and analysis of retinal signals

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Barwon Health University Hospital	Geelong	Victoria
Australia	Albert Road Clinic	Melbourne	Victoria
Canada	Queen's University	Kingston	Ontario
Canada	Douglas Mental Health University Institute	Montréal	Quebec
Canada	Institut Universitaire en Santé Mentale de Montréal	Montréal	Quebec
Canada	CISSS-CA Hôpital de Saint-Georges	Saint-Georges	Quebec
Canada	Centre for Addiction and Mental Health (CAMH)	Toronto	Ontario
United States	McLean Hospital	Belmont	Massachusetts
United States	Collaborative Neuroscience Research LLC	Garden Grove	California
United States	The Zucker Hillside Hospital	Glen Oaks	New York
United States	University Hills Clinical Research	Irving	Texas
United States	Segal trials West Broward Outpatient Site	Lauderhill	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	Segal Trials Miami Lakes Medical Research	Miami Lakes	Florida
United States	Rutgers University Behavioral HealthCare	Piscataway	New Jersey
United States	University of Rochester Medical Center	Rochester	New York
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Collaborative Neuroscience Research LLC	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
diaMentis Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three ERG assessments within 6 weeks.
Primary	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.	Three ERG assessments within 6 weeks.
Primary	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.	Three ERG assessments within 6 weeks.