Enrolling by invitation

Pilot Trial of Mobile Technology for Adolescent Suicidality

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

OTX-207

+ Comparator App + Treatment as Usual (TAU)
Device
Who is being recruted

Suicidal Ideation

From 13 to 17 Years
+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorOui Therapeutics, Inc.
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 23, 2025Actual date on which the first participant was enrolled.

This study explores the effectiveness of two digital tools designed to help reduce suicidal thoughts in teenagers. It includes adolescents and their parents or guardians, aiming to find new ways to support young people facing these challenges. By examining how these digital interventions can make a difference, the study hopes to offer new strategies for preventing and addressing suicidal ideation in teens, a significant concern for their mental health and well-being. Participants in the study will use one of the two digital interventions, although neither they nor the research team will know which specific treatment they are receiving, ensuring an unbiased approach. The study focuses on assessing how these digital tools impact the participants' thoughts over time. While there are no specific outcomes listed, the trial's goal is to measure any changes in the adolescents' feelings and thoughts related to suicidality. By doing so, the research seeks to establish whether these digital methods can be effective in real-world settings.

Official TitleA Randomized Controlled Pilot Trial of Mobile Technology for Reducing and Preventing Adolescent Suicidality 
Principal SponsorOui Therapeutics, Inc.
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
228 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 13 to 17 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Suicidal Ideation
Criteria
11 inclusion criteria required to participate
Patients (of any sex), ages 13 to 17 years
Patients who were recently hospitalized and have
attempted suicide or
have documented SI and a history of attempted suicide, as verified by the Columbia-Suicide Severity Rating Scale (C-SSRS)

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5 exclusion criteria prevent from participating
Patients who are acutely intoxicated or in detoxification at the time of enrollment
Patients who are currently enrolled in other treatment studies for the symptoms and behaviors targeted
Patients who are incapable of understanding and following through with the study procedures (e.g., cognitive impairment)
Patients with a psychiatric or medical condition or custody arrangement that, in the opinion of the PI, may compromise, interfere, limit, affect or reduce the patient's ability to provide informed consent, complete the study, or may adversely impact the safety of the patient or the integrity of the data. Examples of considerations include terminal illness where death would be anticipated before completing study procedures, active psychosis at the time of assent, severe or unstable medical condition

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Group II
Sham
Study Objectives
Primary Objectives

Change in suicidal ideation between baseline and 12 weeks after randomization will be assessed using the Scale for Suicide Ideation (SSI) most severe point of illness score. The possible range of scores is 0-38, where a higher score indicates greater severity of suicide ideation.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Hartford HealthCareHartford, United StatesSee the location
Suspended
University of CincinnatiCincinnati, United States
Suspended
Rhode Island/Bradley Hospital/Brown Health UniversityProvidence, United States
Enrolling by invitation3 Study Centers