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

Phase 2RecruitingNCT07316088

Oui Therapeutics, Inc.40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

PTSD Post Traumatic Stress Disorder

Interventions

OTX-601 Digital TherapeuticDEVICE

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

OTX-003 Comparator appDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Florida State University

Tallahassee, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Change in PTSD symptoms between baseline and week 7

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.

Time frame: Baseline, Week 7

Secondary Outcomes

Change in PTSD symptoms at weeks 15 and 27

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.

Time frame: Week 15, Week 27

Change in Anxiety Sensitivity at weeks 7, 15, and 27

Change in Anxiety Sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.

Time frame: Week 7, Week 15, Week 27

Change in Generalized Anxiety Disorder at weeks 7, 15, and 27

Change in Generalized Anxiety Disorder will be assessed with the Generalized Anxiety Disorder 7-item (GAD-7) assessment. GAD-7 total score for the seven items ranges from 0 to 21 where a score ranging from 0-4 indicates minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.

Time frame: Week 7, Week 15, Week 27

Change in well-being at weeks 7, 15, and 27

Change in well-being will be assessed through the General Life Satisfaction Scale (GLSS). The GLSS total score ranges from 5-35 with higher scores indicating greater life satisfaction.

Time frame: Week 7, Week 15, Week 27

Anxiety sensitivity as a mediator of treatment effects on PTSD symptoms at week 3

Anxiety sensitivity will be ascertained with the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.

Central Contacts

Brian Keenaghan

CONTACT

203-200-0482 brian@ouitherapeutics.com

Data from ClinicalTrials.gov

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