Mobile Technology for Suicidal Thoughts

Enrolling by invitation at 2 trial locations

Overseen By Brian Keenaghan

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oui Therapeutics, Inc.

Disqualifiers: Intoxication, Cognitive impairment, Active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called OTX-207 to determine its effectiveness in reducing suicidal thoughts in teens. It targets those hospitalized after a suicide attempt or due to strong suicidal thoughts. Participants should own a smartphone and be comfortable using apps. The trial aims to discover if the digital tool can influence adolescents' feelings and thoughts about suicide. As an unphased trial, it offers participants the chance to contribute to important research that could lead to new methods of supporting teens in crisis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital intervention is safe for adolescents?

In the absence of specific data from earlier studies on OTX-207, understanding the trial's phase is crucial for assessing safety. The trial is labeled "Not Applicable," indicating an early-stage study focused more on understanding how the treatment works rather than its safety.

Early-stage trials typically provide less safety information compared to later phases, where treatments undergo more thorough testing for side effects. If the FDA had approved OTX-207 for another condition, it might offer more insight into its safety, but that information is unavailable here.

Without specific safety data, participants should know that early trials primarily aim to explore a treatment's benefits. This means there may be limited information about potential risks or side effects at this stage. Discuss any concerns with healthcare providers before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about OTX-207 because it leverages mobile technology to address suicidal thoughts, a novel approach compared to traditional treatments like psychotherapy and medication. Unlike standard care, which often involves in-person therapy sessions or medication regimens, OTX-207 offers real-time support and monitoring through a mobile platform, potentially increasing accessibility and immediacy of care. This method not only provides continuous engagement but also allows for personalized interventions, making it a promising tool for those who may not have easy access to conventional mental health resources.

What evidence suggests that this digital intervention is effective for reducing suicidal thoughts in adolescents?

Research has shown that the digital tool OTX-207, which participants in this trial may receive, can help reduce suicidal thoughts in teenagers. One study found that a similar app lowered suicide attempts by 58.3% in high-risk patients after they left the hospital. Another study demonstrated that mobile apps designed to prevent suicide effectively reduced the chance of repeated attempts. These findings suggest that OTX-207 could support teenagers dealing with suicidal thoughts by providing help and resources on their phones. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for hospitalized adolescents aged 13 to 17 who have suicidal thoughts or behaviors, own a smartphone, and can understand English. They must be able to give informed assent alongside their parent/guardian's consent. Excluded are those with conditions not specified here.

Inclusion Criteria

I, and if applicable, my guardian, understand the study and can sign the consent forms.

I agree to share my health information with my parent/guardian and doctors when needed.

I own a smartphone that can download and run apps.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a digital intervention aimed at reducing suicidal ideation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OTX-207

Trial Overview The study tests the effectiveness of OTX-207, a digital intervention app, against a comparator app plus usual treatment in reducing suicidal ideation in adolescents.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Group II: Control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Oui Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

730+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. medicine.yale.edu medicine.yale.edu/news-article/yale-ohio-state-study-mobile-phone-app-reduced-suicidal-behavior-among-high-risk-patients/

Yale Study: Mobile Phone App Reduced Suicidal Behavior ... The study, published Aug. 8 in JAMA Network Open, found that the app, OTX-202, reduced the recurrence of post-discharge suicide attempts by 58.3 ...

2. patlynk.com patlynk.com/trial/NCT06454136

Pilot Trial of Mobile Technology for Adolescent Suicidality This study explores the effectiveness of two digital tools designed to help reduce suicidal thoughts in teenagers ... OTX-207. + Comparator App + Treatment ...

3. news.cuanschutz.edu news.cuanschutz.edu/news-stories/cu-anschutz-part-of-multi-state-study-smartphone-app-cuts-repeat-suicide-attempts-by-over-half-after-hospital-discharge

Smartphone App Cuts Repeat Suicide Attempts by Over ... A study with researchers from CU Anschutz showed how an app reduced repeated suicide attempts by 58.3%. of patients with a history of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12561950/

Effectiveness of Mobile Applications for Suicide Prevention This meta-analysis aimed to evaluate the effectiveness of mobile applications designed to reduce suicide risk, focusing on studies published ...

5. neurologyadvisor.com neurologyadvisor.com/news/suicide-specific-therapy-app-reduces-suicidal-behavior-inpatients-high-risk/

Suicide-Specific Therapy App Effectively Reduces ... The suicide attempt rate among patients with a prior suicide attempt decreased by 14.0 percent for every digital therapeutic module completed. “ ...

6. njmentalhealthcares.org njmentalhealthcares.org/

New Jersey Mental Health Cares NJMentalHealthCares is New Jersey's behavioral health information and referral service. Our staff of behavioral care specialists use their experience and ...

7. cdc.gov cdc.gov/suicide/facts/index.html

Facts About Suicide | Suicide Prevention Suicide is death caused by injuring oneself with the intent to die. A suicide attempt is when someone harms themselves with any intent to end their life.

8. doh.wa.gov doh.wa.gov/you-and-your-family/injury-and-violence-prevention/suicide-prevention

Suicide Prevention | Washington State Department of Health Call or text 988 or chat online to reach the 988 Suicide & Crisis Lifeline for support with a mental health crisis, substance use concerns, thoughts of ...

9. aacap.org aacap.org/AACAP/AACAP/Families_and_Youth/Facts_for_Families/FFF-Guide/suicide-safety-130.aspx

Suicide Safety: Precautions at Home Suicide is one of the leading causes of death for children, teens and young adults in the United States.

10. dhs.wisconsin.gov dhs.wisconsin.gov/prevent-suicide/index.htm

Suicide Prevention Understanding the complexity of suicide is an important way to support people experiencing suicidal thoughts and behaviors, take part in suicide prevention, ...