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

NCT07316088 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-05

No results posted yet for this study

Summary

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

Conditions

  • PTSD
  • Post Traumatic Stress Disorder

Interventions

DEVICE

OTX-601 Digital Therapeutic

Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

DEVICE

OTX-003 Comparator app

Comparator designed to match interface of intervention while providing no active treatment.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Florida State University

    collaborator OTHER

  • Oui Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-09
Primary Completion
2026-03-20
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316088 on ClinicalTrials.gov