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| ID | Type | Description | Link |
|---|---|---|---|
| R44MH136888 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Florida State University | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-601 Version 1 | Experimental | A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
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| OTX-601 Version 2 | Experimental | Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Therapeutic (Version 1) | Device | Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | week 1, week 2, and week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 1, week 2, week 3 and week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Keenaghan | Contact | (203) 200-0482 | brian@ouitherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Simon, PhD | Oui Therapeutics, Inc. | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 27, 2026 | |
| Reset | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2026 | Jun 23, 2026 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Digital Therapeutic (Version 2) | Device | Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD |
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| Treatment as Usual (TAU) | Behavioral | Treatment as usual may include psychotherapy and/or pharmacological interventions. |
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