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NCT07316088 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Post Traumatic Stress Disorder and PTSD, sponsored by Oui Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT07316088: Recruiting Phase 2 study of Post Traumatic Stress Disorder and PTSD, sponsored by Oui Therapeutics.

NCT07316088 is a Phase 2 study of Post Traumatic Stress Disorder and PTSD that is actively recruiting participants, run by Oui Therapeutics. The registered enrollment target is 40 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07316088, a Phase 2 study of Post Traumatic Stress Disorder and PTSD, is actively recruiting participants, sponsored by Oui Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.

Interventions

  • DEVICE OTX-601 Digital Therapeutic
  • DEVICE OTX-003 Comparator app

Study Locations (1)

Florida

  • Florida State University - Tallahassee

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-12-09
Est. Completion 2026-07-31
Phase Phase 2
Oui Therapeutics

3 total trials

What NCT07316088 shows while recruiting

NCT07316088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which OTX-601 Digital Therapeutic is the first listed.

NCT07316088 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT07316088 about?

NCT07316088 is a clinical study titled "Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms". This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

What is the current status of trial NCT07316088?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-12-09. Estimated completion is 2026-07-31.

What conditions does trial NCT07316088 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder, PTSD.

What interventions are being tested in trial NCT07316088?

The interventions under investigation include: OTX-601 Digital Therapeutic (DEVICE), OTX-003 Comparator app (DEVICE).

Who is sponsoring clinical trial NCT07316088?

This trial is sponsored by Oui Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07316088 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Post Traumatic Stress Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07316088's enrollment target sits among peer trials

40 187th of 262 higher than 65 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07316088, the US trial registry maintained by the National Library of Medicine. NCT07316088 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.