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

NCT05144685 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2025-06-12

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

OTX-202

Experimental Pscyhoeducation and Intervention App

DEVICE

OTX-000

Other Pscyhoeducation App

BEHAVIORAL

Treatment as Usual

Treatment as usual may include appointments with psychiatrists and other mental health clinicians, suicide risk assessment, supportive listening, crisis resources, clinician assessment, and referral to outpatient treatment.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Oui Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2024-06-14
Completion
2024-06-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144685 on ClinicalTrials.gov