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

Oui Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Post Traumatic Stress Disorder; PTSD

Treatments: Device: OTX-601 Digital Therapeutic; Device: OTX-003 Comparator app

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07316088

R44MH136888 (U.S. NIH Grant/Contract)

2024-Oui-002-Study2

Details and patient eligibility

About

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

Full description

The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of OTX-601 (intervention) compared to OTX-003 (comparator) in reducing PTSD symptoms from baseline to 7 weeks.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

OTX-601

Experimental group

Description:

A prescription digital therapeutic designed to overcome existing barriers and deliver evidence based treatment for PTSD

Treatment:

Device: OTX-601 Digital Therapeutic

OTX-003

Sham Comparator group

Description:

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.

Treatment:

Device: OTX-003 Comparator app