Status:
ACTIVE_NOT_RECRUITING
ERG Components in Schizophrenia and Bipolar Disorder Type I
Lead Sponsor:
diaMentis Inc.
Conditions:
Schizophrenia
Bipolar I Disorder
Eligibility:
All Genders
18-50 years
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 u...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03788811
Start Date
July 5 2018
End Date
December 31 2026
Last Update
August 22 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Collaborative Neuroscience Research LLC
Garden Grove, California, United States, 92845
2
Synergy San Diego
Lemon Grove, California, United States, 91945
3
Collaborative Neuroscience Research LLC
Torrance, California, United States, 90502
4
Segal trials West Broward Outpatient Site
Lauderhill, Florida, United States, 33319