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PTSD positive for Post-Traumatic Stress Disorder

N/A
Recruiting
Research Sponsored by Senseye, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

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.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Generalized Anxiety Disorder
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Agreement between Senseye DT and CAPS-5-R assessment at baseline
Agreement between Senseye DT and CAPS-5-R at 12 weeks
Establishment of Ground Truth - GAD/MDD
+1 more
Secondary outcome measures
Time to Administer Tool

Trial Design

6Treatment groups
Experimental Treatment
Group I: Trauma-positive, PTSD/GAD/MDD-negativeExperimental Treatment2 Interventions
Subjects have trauma exposure meeting DSM-5-TR Criterion A, but DO NOT meet criteria for PTSD, GAD, or MDD
Group II: Trauma-negativeExperimental Treatment1 Intervention
Subjects DO NOT have trauma exposure meeting DSM-5-TR Criterion A and DO NOT meet criteria for PTSD, GAD, or MDD
Group III: Primary MDDExperimental Treatment2 Interventions
Subjects DO NOT meet criteria for PTSD, but meet criteria for Major Depressive Disorder
Group IV: Primary GADExperimental Treatment2 Interventions
Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder
Group V: PTSD positiveExperimental Treatment2 Interventions
Subjects meet criteria for PTSD, with or without comorbid Generalized Anxiety Disorder or Major Depressive Disorder
Group VI: Comorbid GAD/MDDExperimental Treatment2 Interventions
Subjects DO NOT meet criteria for PTSD, but meet criteria for Generalized Anxiety Disorder and Major Depressive Disorder

Find a Location

Who is running the clinical trial?

Senseye, Inc.Lead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults With PTSD
2023. "Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05717439.
All > Meridian
~381 spots leftby Dec 2024
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