What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for suicidal thoughts include pharmacological interventions such as antidepressants and non-pharmacological approaches like cognitive-behavioral therapy (CBT). Antidepressants, including SSRIs and SNRIs, can have side effects such as nausea, weight gain, sexual dysfunction, insomnia, and increased anxiety. Psychological interventions like CBT generally have fewer physical side effects but may cause emotional discomfort as patients confront distressing thoughts and feelings. Digital interventions for psychological support and monitoring, similar to those studied in trials, may also lead to increased screen time and potential issues with technology access or literacy.

What prior FDA approvals exist?

The FDA has approved several treatments for managing suicidal thoughts, primarily focusing on pharmacotherapy and psychotherapy. Medications such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are commonly prescribed. Additionally, cognitive-behavioral therapy (CBT) is a widely recognized psychotherapeutic approach. Recently, digital interventions that provide psychological support and remote monitoring have gained attention, although specific FDA approvals for these digital solutions are still emerging. These interventions aim to offer continuous support and timely intervention, similar to the digital therapeutic being studied.

What other types of research exist?

Promising, novel alternatives to digital interventions for patients with suicidal thoughts include: 1) Ketamine and Esketamine therapy, which have shown rapid reduction in suicidal ideation in clinical trials. 2) Psychedelic-assisted therapy, particularly with substances like psilocybin, which is being researched for its potential to alleviate severe depression and suicidal thoughts. 3) Advanced forms of Cognitive Behavioral Therapy (CBT), such as Mindfulness-Based Cognitive Therapy (MBCT) and Acceptance and Commitment Therapy (ACT), which are being adapted for more personalized and intensive treatment settings. 4) Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression and reduce suicidal ideation.

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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 below

Select...

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

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

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

0 / 1Eligibility criteria met

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.