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Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)

NCT06868446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-27

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 - Version 1

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

DEVICE

OTX-601 Digital Therapeutic - Version 2

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

BEHAVIORAL

Treatment as Usual (TAU)

Treatment as usual may include psychotherapy and/or pharmacological interventions.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Florida State University

    collaborator OTHER

  • Oui Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Patricia Simon, PhD · Oui Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-11-18
Completion
2025-11-21
FDA Device
Yes

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 NCT06868446 on ClinicalTrials.gov