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NCT05717439 · ClinicalTrials.gov registry record
Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD
A clinical trial of Major Depressive Disorder and PTSD, sponsored by Senseye.
- Completed
- Registry status
- 338
- Enrollment target
- 5
- Study locations
NCT05717439: Completed study of Major Depressive Disorder and PTSD, sponsored by Senseye.
NCT05717439 is a study of Major Depressive Disorder and PTSD that has completed, run by Senseye. The registered enrollment target is 338 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (10% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05717439, a study of Major Depressive Disorder and PTSD, has completed, sponsored by Senseye.
- COMPLETED
- Registry status
- 338 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST CAPS-5-R
- DIAGNOSTIC_TEST Senseye DT
Study Locations (5)
Texas
- Future Search Trials - Dallas
- DHR Health Institute for Research and Development - Edinburg
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Idaho
- Velocity Clinical Research - Meridian
South Carolina
- Ralph H. Johnson VA Health Care System - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2024-07-25 |
What the finished NCT05717439 record still lists
NCT05717439 is an observational study that tracks outcomes without assigning an intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (10% lower).
The record links to 3 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which CAPS-5-R is the first listed.
NCT05717439 lists 5 locations in 4 states (Texas, Colorado, Idaho).
Frequently Asked Questions
What is clinical trial NCT05717439 about?
NCT05717439 is a clinical study titled "Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD". 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 a...
What is the current status of trial NCT05717439?
This trial is currently completed. The enrollment target is 338 participants. The study started on 2023-03-01. Estimated completion is 2024-07-25.
What conditions does trial NCT05717439 study?
This clinical trial studies the following conditions: Major Depressive Disorder, PTSD, Generalized Anxiety Disorder.
What interventions are being tested in trial NCT05717439?
The interventions under investigation include: CAPS-5-R (DIAGNOSTIC_TEST), Senseye DT (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05717439?
This trial is sponsored by Senseye, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05717439 being conducted?
This trial has 5 study locations across Colorado, Idaho, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05717439's enrollment target sits among peer trials
338 49th of 282 higher than 234 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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