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

Oui Therapeutics, Inc.6 sites in 1 country356 target enrollmentApril 7, 2022

ConditionsSuicide, Attempted Suicidal Ideation

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Suicide, Attempted
Sponsor: Oui Therapeutics, Inc.
Enrollment: 356
Locations: 6
Primary Endpoint: Columbia-Suicide Severity Rating Scale(C-SSRS)
Status: Terminated
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 7, 2022

End Date

June 14, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Oui Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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