OTX-601 for PTSD

Overseen By Brian Keenaghan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Oui Therapeutics, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

Anxiety Sensitivity Index 3 (ASI-3) scores above 24

PTSD Checklist for DSM-V (PCL-5) scores above 30

Understands and speaks English

Exclusion Criteria

Score of 24 or lower on the ASI-3

Score of 30 and below on the PCL-5

Active psychosis

What Are the Treatments Tested in This Trial?

Interventions

• OTX-601

How Is the Trial Designed?

Group I: OTX-601 Experimental Treatment 1 Intervention

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

Group II: OTX-003 Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Oui Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

730+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+