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

Oui Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Suicide, Attempted; Suicidal Ideation

Treatments: Behavioral: Treatment as Usual; Device: OTX-000; Device: OTX-202

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05144685

2020-Oui-001

2R42MH123357-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ages ≥18 years old
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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356 participants in 2 patient groups

Experimental App + Treatment as Usual

Experimental group

Description:

This intervention will be for the treatment group

Treatment:

Device: OTX-202

Behavioral: Treatment as Usual

Other App + Treatment as Usual

Experimental group

Description:

This intervention will be for the control group

Treatment:

Behavioral: Treatment as Usual

Device: OTX-000