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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05144685
• Other study ID #: 2020-Oui-001
• Secondary ID: 2R42MH123357-02
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: April 7, 2022
• Est. completion date: April 6, 2025

Study information

• Verified date: August 2023
• Source: Oui Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 391
• Est. completion date: April 6, 2025
• Est. primary completion date: April 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Device:
• OTX-202
Experimental Pscyhoeducation and Intervention App
• OTX-000
Other Pscyhoeducation App

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Harding Hospital	Columbus	Ohio
United States	UCDDenver / Denver Health	Denver	Colorado
United States	Northwell Health	Glen Oaks	New York
United States	Yale	New Haven	Connecticut
United States	Common Spirit	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Oui Therapeutics, Inc.	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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