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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
No Placebo-Only Group
Summary
This trial is testing a digital program designed to help people reduce their risk of attempting suicide. It involves 391 participants who are at risk of suicide. The program offers tools and support to help them manage their thoughts and feelings.
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.
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.
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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, week 4, week 8, week 12, week 24, week 52, week 78, week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, week 4, week 8, week 12, week 24, week 52, week 78, week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Columbia-Suicide Severity Rating Scale(C-SSRS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for suicidal thoughts include psychological interventions and pharmacotherapy. Psychological interventions like cognitive-behavioral therapy (CBT) and dialectical behavior therapy (DBT) help patients change negative thought patterns, improve emotional regulation, and develop coping strategies.
Pharmacotherapy, such as selective serotonin reuptake inhibitors (SSRIs), works by altering neurotransmitter levels to improve mood. Digital interventions provide continuous psychological support and real-time monitoring, offering immediate crisis intervention and ongoing emotional support, which is crucial for reducing the risk of suicide attempts.
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Who is running the clinical trial?
Oui Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
299 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,741,651 Total Patients Enrolled
6 Trials studying Suicide Attempt
28,972 Patients Enrolled for Suicide Attempt
Oui Therapeutics, LLCLead Sponsor
3 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I do not have any health issues that would stop me from completing the study.I understand what this study involves.
Research Study Groups:
This trial has the following groups:- Group 1: Other App + Treatment as Usual
- Group 2: Experimental App + Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.