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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03788811




Registration number
NCT03788811
Ethics application status
Date submitted
20/12/2018
Date registered
28/12/2018
Date last updated
7/03/2024

Titles & IDs
Public title
ERG Components in Schizophrenia and Bipolar Disorder Type I
Scientific title
Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I
Secondary ID [1] 0 0
dM/CL-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Bipolar I Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - ERG assessment (RSPA)

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.

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).

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).


Treatment: Devices: ERG assessment (RSPA)
Processing and analysis of retinal signals
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Differences in ERG components vs control ERG with full-field ERG stimulation conditions.
Timepoint [1] 0 0
Three ERG assessments within 6 weeks.
Primary outcome [2] 0 0
Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.
Timepoint [2] 0 0
Three ERG assessments within 6 weeks.
Primary outcome [3] 0 0
Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.
Timepoint [3] 0 0
Three ERG assessments within 6 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Barwon Health University Hospital - Geelong
Recruitment hospital [3] 0 0
Albert Road Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
diaMentis Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03788811
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claude Hariton, PhD, DSc
Address 0 0
diaMentis Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries