NCT07316088 Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms
| NCT ID | NCT07316088 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oui Therapeutics, Inc. |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2026-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-12-09 with a primary completion date of 2026-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Eligibility Criteria
Inclusion Criteria: * Posttraumatic stress disorder (PTSD) diagnosis * 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 24 or lower on the ASI-3 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07316088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07316088 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07316088 currently recruiting?
Yes, NCT07316088 is actively recruiting participants. Contact the research team at brian@ouitherapeutics.com for enrollment information.
Where is the NCT07316088 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT07316088 clinical trial?
NCT07316088 is sponsored by Oui Therapeutics, Inc.. The trial plans to enroll 40 participants.
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