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Behavioural Intervention

Digital Therapeutic for Suicide Prevention

Phase 2 & 3
Waitlist Available
Research Sponsored by Oui Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages ≥18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, week 4, week 8, week 12, week 24, week 52, week 78, week 104
Awards & highlights

Study Summary

This trial will test if a digital intervention can help reduce suicide attempts.

Who is the study for?
This trial is for adults over 18 who've recently been hospitalized for suicide-related issues. Participants must understand the study, own a smartphone, and be willing to follow enrollment steps and provide contacts. It's not for those in other studies, with conditions affecting participation, untreated psychosis, substance impairment or cognitive issues.Check my eligibility
What is being tested?
The trial tests two digital interventions, OTX-202 and OTX-000, designed to reduce suicide attempts. The effectiveness of these digital tools will be evaluated among participants using their smartphones as part of the treatment process.See study design
What are the potential side effects?
Since this is a digital therapeutic intervention focusing on mental health support through a smartphone application, traditional physical side effects are not expected; however, potential emotional or psychological responses vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, week 4, week 8, week 12, week 24, week 52, week 78, week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, week 4, week 8, week 12, week 24, week 52, week 78, week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Columbia-Suicide Severity Rating Scale(C-SSRS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Other App + Treatment as UsualExperimental Treatment1 Intervention
This intervention will be for the control group
Group II: Experimental App + Treatment as UsualExperimental Treatment1 Intervention
This intervention will be for the treatment group

Find a Location

Who is running the clinical trial?

Oui Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
41 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,716 Total Patients Enrolled
1 Trials studying Suicidal Thoughts
240 Patients Enrolled for Suicidal Thoughts
Oui Therapeutics, LLCLead Sponsor
3 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Digital Therapeutic (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05144685 — Phase 2 & 3
Suicidal Thoughts Research Study Groups: Other App + Treatment as Usual, Experimental App + Treatment as Usual
Suicidal Thoughts Clinical Trial 2023: Digital Therapeutic Highlights & Side Effects. Trial Name: NCT05144685 — Phase 2 & 3
Digital Therapeutic (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144685 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be an ideal candidate to participate in this clinical trial?

"This clinical study only accepts patients that have attempted suicide and are between the ages of 22 to 70. The research team is looking for around 391 individuals."

Answered by AI

Can new patients still sign up for this clinical trial?

"Currently, this clinical trial is not enrolling patients. As seen on clinicaltrials.gov, the study was posted on April 7th, 2022 and has not been updated since. Although this particular trial is not recruiting right now, there are 222 other trials that are accepting participants."

Answered by AI

Is this research project currently seeking volunteers who are over 20 years old?

"The age range for participants in this clinical trial is 22 to 70 years old."

Answered by AI

Who else is applying?

What state do they live in?
New York
Ohio
How old are they?
65+
What site did they apply to?
Harding Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I very interested on the study and could have an online consultation.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic
2022. "A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05144685.
~123 spots leftby Apr 2025
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