Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms
NCT ID: NCT07316088
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-12-09
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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OTX-601
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD
OTX-601 Digital Therapeutic
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
OTX-003
OTX-003 is a smartphone application developed as a comparator to OTX-601 and designed to match its interface while providing no active PTSD treatment.
OTX-003 Comparator app
Comparator designed to match interface of intervention while providing no active treatment.
Interventions
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OTX-601 Digital Therapeutic
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
OTX-003 Comparator app
Comparator designed to match interface of intervention while providing no active treatment.
Eligibility Criteria
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Inclusion Criteria
* Anxiety Sensitivity Index 3 (ASI-3) scores above 24
* PTSD Checklist for DSM-V (PCL-5) scores above 30
* Understands and speaks English
* Access to a smartphone that is connected to the internet
Exclusion Criteria
* Score of 30 and below on the PCL-5
* No PTSD diagnosis
* Active psychosis
* Acute intoxication during study baseline
* Enrolled in another treatment research study
* Medical illness that would prevent the completion of interoceptive exposure exercises
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Florida State University
OTHER
Oui Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Florida State University
Tallahassee, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-Oui-002-Study2
Identifier Type: -
Identifier Source: org_study_id
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