PTSDPhase 1NCT06868446
Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)
A Phase 1 study testing OTX-601 Digital Therapeutic - Version 1, OTX-601 Digital Therapeutic - Version 2 and Treatment as Usual (TAU) in people with PTSD and Post Traumatic Stress Disorder, run by Oui Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- OTX-601 Digital Therapeutic - Version 1, OTX-601 Digital Therapeutic - Version 2 and Treatment as Usual (TAU)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 21 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Dosage, Feasibility, Acceptability and Usability of OTX-601
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Read the detailed description
The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- OTX-601 Digital Therapeutic - Version 1, OTX-601 Digital Therapeutic - Version 2, Treatment as Usual (TAU)
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-601 Digital Therapeutic - Version 1Device
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
OTX-601 Digital Therapeutic - Version 2Device
Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Treatment as Usual (TAU)Behavioural
Treatment as usual may include psychotherapy and/or pharmacological interventions.
| Study group | Role | What they receive |
|---|---|---|
| OTX-601 Digital Therapeutic - Version 1 | Experimental | A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD Receives: Device: OTX-601 Digital Therapeutic - Version 1; Behavioral: Treatment as Usual (TAU) |
| OTX-601 Digital Therapeutic - Version 2 | Experimental | Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD Receives: Device: OTX-601 Digital Therapeutic - Version 2; Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-V (PCL-5)
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.
Measured: Baseline, week 1, week 2, week 3, and week 7
System Usability Scale (SUS)
App usability will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.
Measured: week 1, week 2, and week 3
Secondary outcomes (1)
Anxiety Sensitivity Index 3 (ASI-3)
Change in anxiety sensitivity level 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.
Measured: Baseline, week 1, week 2, week 3 and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start30 Jun 2025
- Primary completion18 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oui Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Simon, PhD, Principal investigator, Oui Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868446
- Sponsor's protocol ID
- 2024-Oui-002-Study1
- Other IDs
- R44MH136888
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage, Feasibility, Acceptability and Usability of OTX-601
- ClinicalTrials.gov ID
- NCT06868446
- Acronym / sponsor ID
- 2024-Oui-002-Study1
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oui Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Florida State University
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Detailed description
The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTX-601 Digital Therapeutic - Version 1 | Experimental | Device: OTX-601 Digital Therapeutic - Version 1, Behavioral: Treatment as Usual (TAU)A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
| OTX-601 Digital Therapeutic - Version 2 | Experimental | Device: OTX-601 Digital Therapeutic - Version 2, Behavioral: Treatment as Usual (TAU)Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTX-601 Digital Therapeutic - Version 1Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD | Device | OTX-601 Digital Therapeutic - Version 1 |
| OTX-601 Digital Therapeutic - Version 2Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD | Device | OTX-601 Digital Therapeutic - Version 2 |
| Treatment as Usual (TAU)Treatment as usual may include psychotherapy and/or pharmacological interventions. | Behavioural | OTX-601 Digital Therapeutic - Version 1, OTX-601 Digital Therapeutic - Version 2 |
Primary outcome
PTSD Checklist for DSM-V (PCL-5)
Time frame: Baseline, week 1, week 2, week 3, 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.
System Usability Scale (SUS)
Time frame: week 1, week 2, and week 3
App usability will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.
1 secondary outcome
Anxiety Sensitivity Index 3 (ASI-3)
Time frame: Baseline, week 1, week 2, week 3 and week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Simon, PhD principal investigator
Oui Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTX-601 Digital Therapeutic - Version 1, OTX-601 Digital Therapeutic - Version 2 and Treatment as Usual (TAU) in people with PTSD and Post Traumatic Stress Disorder, run by Oui Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-V (PCL-5) (time frame: Baseline, week 1, week 2, week 3, and week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.