Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Oui Therapeutics, Inc.
Study ID
NCT07316088
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OTX-601 Digital Therapeutic — DEVICE
    Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
  • OTX-003 Comparator app — DEVICE
    Comparator designed to match interface of intervention while providing no active treatment.

Study Details

This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

Key Dates

Start date
Dec 9, 2025
Status verified
Dec 2025
Primary completion
Mar 20, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OTX-601
    A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD
  • Sham Comparator: 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.

Primary Outcome Measure

Change in PTSD symptoms between baseline and week 7 [ Time Frame: Baseline, Week 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32306
Professor of Psychology
[email protected]
850-645-8729
Jesse Cougle, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tallahassee, FL

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Florida State University· Tallahassee, FL

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