ERG Assessment for Schizophrenia and Bipolar Disorder

Not currently recruiting at 20 trial locations

Overseen By Claude Hariton, PhD, DSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: diaMentis Inc.

Must not be taking: Antipsychotics

Disqualifiers: Dementia, Parkinson's, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a software tool that helps diagnose schizophrenia and bipolar disorder type I by analyzing eye tests. The diaMentis proprietary software examines unique patterns in the retina (the back part of the eye) to assist doctors in making accurate diagnoses. Participants may qualify if they have been diagnosed with schizophrenia or bipolar disorder type I for at least a year. Control subjects should have no history of psychotic or mood disorders.

As an unphased trial, this study offers a unique opportunity to contribute to innovative diagnostic technology that could enhance mental health care.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but control subjects cannot take antipsychotic drugs. Other prescription medicines are allowed for control subjects.

What prior data suggests that this software is safe for use in diagnosing schizophrenia and bipolar disorder type I?

Research has shown that the diaMentis software, which aids in diagnosing schizophrenia and bipolar disorder, is part of the FDA's Breakthrough Devices Program. This program includes technologies that hold promise for patients. Although specific side effects for this software are not detailed, its inclusion in the program suggests it might be safe to use.

The ERG assessment (RSPA) measures electrical activity in the eye to assist in diagnosing these conditions. Researchers are studying its ability to differentiate between schizophrenia and bipolar disorder. No reports of side effects from ERG assessments for this purpose exist, suggesting the procedure might be well-tolerated, though further research is needed to confirm its safety.

When considering participation in a trial, this information can help clarify the safety of the treatments under study. Always consult healthcare professionals for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ERG assessment using diaMentis proprietary software because it's a novel approach to understanding and diagnosing schizophrenia and bipolar disorder Type I. Unlike standard treatments that primarily focus on managing symptoms with medication, this method aims to provide deeper insights into the conditions by analyzing electrical activity in the brain. This innovative technique could pave the way for more precise diagnostics, potentially leading to more personalized and effective treatment plans for patients.

What evidence suggests that this software is effective for diagnosing schizophrenia and bipolar disorder?

This trial will evaluate the effectiveness of diaMentis proprietary software and ERG assessment (RSPA) in diagnosing psychiatric conditions. Research has shown that the diaMentis software, which uses advanced computer techniques, might help predict schizophrenia and bipolar disorder. One study found that these computer tools can better predict when someone might develop these conditions by using clinical data, potentially aiding earlier diagnosis.

Regarding the ERG test, which reads signals from the eye's retina, studies suggest it could be useful for spotting psychiatric conditions. The electroretinogram (ERG) is considered a promising indicator for schizophrenia and bipolar disorder, possibly aiding diagnosis. This trial will assess whether using both technologies together could enhance the accuracy of diagnosing these mental health conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Claude Hariton, PhD, DSc

Principal Investigator

diaMentis Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to give written informed consent;

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

ERG Assessment

Participants undergo three ERG assessments using different stimulation conditions to evaluate retinal signal features

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ERG assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• diaMentis proprietary software
• ERG assessment (RSPA)

How Is the Trial Designed?

Group I: Patients with schizophrenia (SZ) Experimental Treatment 1 Intervention

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).

Group II: Patients with bipolar disorder Type I (BP1) Experimental Treatment 1 Intervention

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).

Group III: Control subjects Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

diaMentis Inc.

Lead Sponsor

Trials

1

Recruited

300+

Citations

1. ctv.veeva.com ctv.veeva.com/study/erg-components-in-schizophrenia-and-bipolar-disorder-type-i

ERG Components in 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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1746809424014319

High-density retinal signal deciphering in support of ... We developed the concept of high-density retinal signal, with the specific target of modeling mathematical domains of information gathered from retinal signals.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9673390/

Developing a clinical decision tool based on ... This study further supports the potential of ERG to become a useful clinical decision tool to decide the course of action for subjects at risk of SMI.

4. academic.oup.com academic.oup.com/schizbullopen/article/3/1/sgac016/6522983

Electroretinogram as a Potential Biomarker of Psychosis in ... We previously proposed the electroretinogram (ERG) as a promising biomarker of major psychiatric disorders such as schizophrenia (SZ) and ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.960512/full

Bipolar disorders and retinal electrophysiological markers ... The primary outcome will be electrophysiological measurements with ERG flash and pattern. Secondary outcomes will be EEG data, sleep settings, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5546554/

Rating Scales and Safety Measurements in Bipolar ... The goal of this reference guide is to assist mental health experts in understanding valid and reliable 3 rating scales in schizophrenia and bipolar disorder.

7. research.monash.edu research.monash.edu/en/projects/assessment-of-erg-components-to-discriminate-between-schizophreni/

Assessment of ERG components to discriminate between ... Assessment of ERG components to discriminate between schizophrenia and bipolar disorder type I. Sundram, Suresh (Primary Chief Investigator (PCI)).

8. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=4877352

Collaborative Neuroscience Research Trials ... Safety of ... NCT03788811: ERG Components in Schizophrenia and Bipolar Disorder Type I. Active, not recruiting. N/A. 300. Canada, US, RoW. ERG assessment (RSPA).

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10306372/

Clinical Outcome Assessment Instruments in Schizophrenia This review provides a comprehensive overview of the clinical outcome assessments used in schizophrenia research during the past ten years.