Health TrialsbyHealthPanel

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

ConditionsPTSDPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOui Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Score of 24 or lower on the ASI-3

Score of 30 and below on the PCL-5

No PTSD diagnosis

Active psychosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • OTX-601 Digital Therapeutic

    Device

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

  • OTX-003 Comparator app

    Device

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: OTX-601Experimental treatment 1 intervention
Group B: OTX-003Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oui Therapeutics, Inc.

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Florida State University

Collaborator

Source ClinicalTrials.gov
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