Major Depressive Disorder Clinical Trial
Official title:
Machine-Learning Training Study of the Senseye Diagnostic Tool for Diagnosis of Adults With Post-Traumatic Stress Disorder (PTSD), Anxiety, and Depression
The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Willing and able to read, understand, and sign the IRB-approved Informed Consent Form. 2. Age 18+. 3. Study groups: Diagnosed with PTSD, GAD, and/or MDD. 4. Control groups: Not diagnosed with PTSD, GAD, or MDD. 5. Deemed likely to comply with the study protocol, including willing communication of adverse events (AEs), mental health treatment history, current and past psychiatric medication, and ability to attend all study follow-up visits. 6. Medically stable as determined by the clinician or investigator. 7. Virtual sites: Subject has access to a stable internet and WIFI connection and an iPhone 11 or newer. Exclusion Criteria: 1. Psychotic or self-injurious behavior. 2. Current diagnosis of epilepsy and/or other current seizure disorders. 3. A history of or positive at screening for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, and psychosis. 4. Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions). 5. Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction. 6. Current eye disorders which prevent the patient from using the Senseye DT (complete list in full protocol). 7. Active suicidal and/or homicidal intent which may put the participant and/or others at risk per the investigator's clinical judgement, or has suicidal ideation with intent to act within 6 months prior to the start of the screening phase as determined by a C-SSRS score > 3, or history of suicidal behavior within the past year prior to the start of the screening phase. 8. Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of psychotropic and/or non-psychotropic drugs/medication which may affect use of the Senseye DT (complete list in full protocol). 9. Current reported usage (within 2 weeks of Initial Study Visit and/or planned ongoing usage during the study) of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or electroconvulsive therapy. 10. Any condition which precludes the ability for subjects to safely and accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT (e.g., significant developmental disabilities, language disorders, cognitive deficiencies, or other neurodevelopmental disorders). 11. Traumatic Brain Injury (TBI) within the last 12 months. 12. Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS. 13. Pregnant or intending on becoming pregnant during the duration of the study as determined by self-report. 14. Currently incarcerated. 15. Participant requires a legal guardian to consent. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
United States | Ralph H. Johnson VA Health Care System | Charleston | South Carolina |
United States | Future Search Trials | Dallas | Texas |
United States | DHR Health Institute for Research and Development | Edinburg | Texas |
United States | Velocity Clinical Research | Meridian | Idaho |
Lead Sponsor | Collaborator |
---|---|
Senseye, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement between Senseye DT and CAPS-5-R assessment at baseline | The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at Baseline. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test. | Baseline | |
Primary | Agreement between Senseye DT and CAPS-5-R at 12 weeks | The Senseye DT demonstrates a statistically significant difference (p<0.05) of ocular signal and/or heart rate data between subjects with PTSD and/or GAD and/or MDD and control subjects at the 12-week follow-up time point. Senseye DT results and clinical assessment diagnosis results will be compared using a 2-sample t-test or Wilcoxon rank-sum test. | 12 weeks | |
Primary | Establishment of Ground Truth - PTSD | To obtain data using the Senseye DT measures in both PTSD and control subjects to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of PTSD. | Baseline & 12 weeks | |
Primary | Establishment of Ground Truth - GAD/MDD | To obtain data using the Senseye DT to establish a "ground truth" for the Senseye DT's machine learning algorithm to use for objectively diagnosing and ranking severity of GAD and/or MDD. | Baseline & 12 weeks | |
Secondary | Time to Administer Tool | The Senseye DT demonstrates significantly less time to administer than the CAPS-5-R, based on actual recorded time for study staff to administer each assessment. Senseye DT time and CAPS-5-R time will be compared using a 2-sample t-test or Wilcoxon rank-sum test. | Baseline & 12 weeks |
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