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

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

Study Overview

• Status: Terminated
• Conditions: Suicidal Ideation; Suicide, Attempted
• Intervention / Treatment: Device: OTX-202; Device: OTX-000; Behavioral: Treatment as Usual

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 Type: Interventional
• Enrollment (Actual): 356
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • UCDDenver / Denver Health
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Common Spirit
  • New York
    • Glen Oaks, New York, United States, 11004
      • Northwell Health
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Columbus, Ohio, United States, 43210
      • Harding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental App + Treatment as Usual; This intervention will be for the treatment group	Device: OTX-202; Experimental Pscyhoeducation and Intervention 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.; Other Names: TAU
Experimental: Other App + Treatment as Usual; This intervention will be for the control group	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.; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oui Therapeutics, Inc.
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 2020-Oui-001; 2R42MH123357-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes