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

Sponsor
Oui Therapeutics, LLC (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05144685
Collaborator
National Institute of Mental Health (NIMH) (NIH)
391
Enrollment
3
Locations
2
Arms
36
Anticipated Duration (Months)
130.3
Patients Per Site
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: OTX-202
  • Device: OTX-000
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
391 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants and research assessors will be blinded to treatment assignment.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 7, 2022
Anticipated Primary Completion Date :
Apr 6, 2025
Anticipated Study Completion Date :
Apr 6, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Suicide Attempt Self-Injury Interview (SASII) [Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104]

    The SASII will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCDDenver / Denver Health Denver Colorado United States 80204
2 Yale New Haven Connecticut United States 06511
3 Harding Hospital Columbus Ohio United States 43210

Sponsors and Collaborators

  • Oui Therapeutics, LLC
  • National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oui Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT05144685
Other Study ID Numbers:
  • 2020-Oui-001
  • 2R42MH123357-02
First Posted:
Dec 3, 2021
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide, Attempted

Study Results

No Results Posted as of Apr 14, 2022