NCT05144685

A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic

A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Oui Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.

Detailed description

This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.

Conditions

• Suicide, Attempted
• Suicidal Ideation

Interventions

Type	Name	Description
DEVICE	OTX-202	Experimental Pscyhoeducation and Intervention App
DEVICE	OTX-000	Other Pscyhoeducation App
BEHAVIORAL	Treatment as Usual	Treatment as usual may include appointments with psychiatrists and other mental health clinicians, suicide risk assessment, supportive listening, crisis resources, clinician assessment, and referral to outpatient treatment.

Timeline

• Start date: 2022-04-07
• Primary completion: 2024-06-14
• Completion: 2024-06-14
• First posted: 2021-12-03
• Last updated: 2025-06-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study