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

Primary Purpose

Suicide, Attempted, Suicidal Ideation

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTX-202
OTX-000
Sponsored by
Oui Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Ages 22 to 70 years
  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

Sites / Locations

  • UCDDenver / Denver Health
  • Yale
  • Common Spirit
  • Northwell Health
  • University of Cincinnati
  • Harding Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental App + Treatment as Usual

Other App + Treatment as Usual

Arm Description

This intervention will be for the treatment group

This intervention will be for the control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2021
Last Updated
August 8, 2023
Sponsor
Oui Therapeutics, Inc.
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05144685
Brief Title
A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
April 6, 2025 (Anticipated)
Study Completion Date
April 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oui Therapeutics, Inc.
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and research assessors will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
391 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental App + Treatment as Usual
Arm Type
Experimental
Arm Description
This intervention will be for the treatment group
Arm Title
Other App + Treatment as Usual
Arm Type
Experimental
Arm Description
This intervention will be for the control group
Intervention Type
Device
Intervention Name(s)
OTX-202
Intervention Description
Experimental Pscyhoeducation and Intervention App
Intervention Type
Device
Intervention Name(s)
OTX-000
Intervention Description
Other Pscyhoeducation App
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale(C-SSRS)
Description
The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.
Time Frame
Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
UCDDenver / Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Common Spirit
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Northwell Health
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Harding Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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