ERG Components in Schizophrenia and Bipolar Disorder Type I

Recruiting at18 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: diaMentis Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Claude Hariton, PhD, DSc

Principal Investigator

diaMentis Inc.

Eligibility Criteria

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);

Treatment Details

Interventions

• diaMentis proprietary software (Software as Medical Device)
• ERG assessment (RSPA) (Procedure)

Participant Groups

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+