Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ERG Components in Schizophrenia and Bipolar Disorder Type I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788811
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
diaMentis Inc.

Brief 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.

Condition or disease Intervention/treatment
Schizophrenia Bipolar I Disorder Device: ERG assessment (RSPA)

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: ERG assessment (RSPA)
Processing and analysis of retinal signals

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

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
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);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788811


Contacts
Layout table for location contacts
Contact: Claude Hariton, PhD, DSc 418-380-5757 chariton@diamentis.com
Contact: Claudia Émond, MSc 418-380-5757 cemond@diamentis.com

Locations
Layout table for location information
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Abdullah Cagri Yuksel, MD    617-855-2779    ayuksel@partners.org   
United States, New Jersey
Rutgers University Behavioral HealthCare Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Steven M Silverstein, PhD    732-235-5149    silvers1@ubhc.rutgers.edu   
Principal Investigator: Steve Silverstein, PhD         
Canada, Ontario
Centre for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Ofer Agid, MD, PhD    416-535-8501 ext 34862    Ofer.Agid@camh.ca   
Canada, Quebec
Institut Universitaire en Santé Mentale de Montréal Recruiting
Montréal, Quebec, Canada, H1N 3M5
Contact: Valérie Tourjman, MD, PhD       vtourjman.iusmm@ssss.gouv.qc.ca   
Principal Investigator: Valérie Tourjman, MD, PhD         
Sponsors and Collaborators
diaMentis Inc.
Investigators
Layout table for investigator information
Study Director: Claude Hariton, PhD, DSc diaMentis Inc.

Layout table for additonal information
Responsible Party: diaMentis Inc.
ClinicalTrials.gov Identifier: NCT03788811     History of Changes
Other Study ID Numbers: dM/CL-01
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by diaMentis Inc.:
Retinal Signal
Schizophrenia
Bipolar I Disorder
Support to diagnostic
ERG
Mental Disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders