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

Phase 2

Terminated

• Conditions: Suicide, Attempted; Suicidal Ideation
• Interventions: Device: OTX-202; Device: OTX-000

• Registration Number: NCT05144685
• Lead Sponsor: Oui Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Study Start: 2022-04-07
• Primary Completion: 2024-06-14
• Study Completion: 2024-06-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

1. Ages ≥18 years old
2. Patients recently hospitalized.
3. Owns a smartphone.
4. Willing and able to complete enrollment procedures.
5. Able to understand the nature of the study.
6. Able and willing to provide at least two verifiable contacts.

Exclusion Criteria

1. Patients who have untreated psychosis or active psychosis
2. Patients who appear to be impaired by the use of alcohol or other substance(s)
3. Patients who sign, or have signed, an informed consent form to participate in any clinical research
4. Patients who upon clinical examination are cognitively impaired
5. Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental App + Treatment as Usual	OTX-202	This intervention will be for the treatment group
Other App + Treatment as Usual	OTX-000	This intervention will be for the control group

Primary Outcome Measures

Name	Time	Method
Columbia-Suicide Severity Rating Scale(C-SSRS)	Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104	The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.

Trial Locations

Locations (6)

UCDDenver / Denver Health; 🇺🇸 Denver, Colorado, United States

Yale; 🇺🇸 New Haven, Connecticut, United States

Common Spirit; 🇺🇸 Omaha, Nebraska, United States

Northwell Health; 🇺🇸 Glen Oaks, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Harding Hospital; 🇺🇸 Columbus, Ohio, United States