← Back to Search

Software as Medical Device

Patients with bipolar disorder Type I (BP1) for Bipolar Disorder

N/A
Waitlist Available
Research Sponsored by diaMentis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three erg assessments within 6 weeks.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Bipolar Disorder
  • Schizophrenia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three erg assessments within 6 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and three erg assessments within 6 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.
Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.
Differences in ERG components vs control ERG with full-field ERG stimulation conditions.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Patients with schizophrenia (SZ)Experimental Treatment1 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 Treatment1 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 subjectsExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

diaMentis Inc.Lead Sponsor
Claude Hariton, PhD, DScStudy DirectordiaMentis Inc.
~8 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top