Back to resultsA 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
About this trial
This is an interventional treatment trial for Suicide, Attempted
Eligibility Criteria
Inclusion Criteria:
- Ages 22 to 70 years
- 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
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
NCT ID
NCT05144685
First Posted
November 11, 2021
Last Updated
August 8, 2023
Sponsor
Oui Therapeutics, Inc.
Collaborators
National Institute of Mental Health (NIMH)
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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