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

August 8, 2023 updated by: Oui Therapeutics, Inc.

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 (Estimated)

391

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Experimental: Other App + Treatment as Usual
This intervention will be for the control group
Device: OTX-000
Other Pscyhoeducation App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia-Suicide Severity Rating Scale(C-SSRS)
Time Frame: 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.
Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oui Therapeutics, Inc.

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Estimated)

April 6, 2025

Study Completion (Estimated)

April 6, 2025

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)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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