Suicidal IdeationNCT06454136
Pilot Trial of Mobile Technology for Adolescent Suicidality
A study testing OTX-207 and Comparator App + Treatment as Usual (TAU) in people with Suicidal Ideation, run by Oui Therapeutics, Inc. at 3 sites in United States.
Trial summary
The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- OTX-207 and Comparator App + Treatment as Usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
- Hospitalized is defined as admission to a medical or psychiatric service for further assessment and care including observation units, intensive care or other medical units and psychiatric units.
- Patient owns a smartphone capable of downloading and running apps
Show all 11Show fewer
- Patient is willing and able to complete enrollment procedures
- Patient and Parent/Guardian are willing to assent/consent to medical record review for one year following randomization to collect suicide attempt data
- Patient and Parent/Guardian are able to understand the nature of the study and sign documentation of written informed assent (Patient) and consent (Parent/Guardian)
- Patient and Parent/Guardian understand written and spoken English
- Patient is willing to agree to release of information to their Parent/Guardian and providers when clinically indicated
Who cannot join
- 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.
- Patients whose discharge plans include transfer to inpatient care, as confirmed by the index hospitalization discharge summary/plan.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Hartford HealthCare
Hartford, Connecticut, 06106
Rhode Island/Bradley Hospital/Brown Health University
Providence, Rhode Island, 02903
About this study
Official title: A Randomized Controlled Pilot Trial of Mobile Technology for Reducing and Preventing Adolescent Suicidality
The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.
Read the detailed description
This double blind, randomized controlled trial will evaluate the preliminary efficacy of two digital interventions among 114 adolescent participants, and their parents/guardians, in reducing suicidal ideation in the adolescent participants. Adolescent participants, parent/guardian participants, and research assessors will be blinded to treatment assignment.
- Conditions
- Suicidal Ideation
- Being tested
- OTX-207, Comparator App + Treatment as Usual (TAU)
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-207Device
Experimental Pscyhoeducation and Intervention App
Comparator App + Treatment as Usual (TAU)Device
Digitized content and information included in standard of care (i.e., TAU)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: OTX-207 |
| Control | Sham comparator | Not described Receives: Device: Comparator App + Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Suicide Ideation (SSI)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start23 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oui Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454136
- Sponsor's protocol ID
- 2024-Oui-001
- Other IDs
- 6R42MH125691-03
- Status last verified
- Nov 2025
- First submitted
- 6 Jun 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Trial of Mobile Technology for Reducing and Preventing Adolescent Suicidality
- ClinicalTrials.gov ID
- NCT06454136
- Acronym / sponsor ID
- 2024-Oui-001
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Oui Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the efficacy of a digital intervention in reducing suicidal ideation in adolescents.
Detailed description
This double blind, randomized controlled trial will evaluate the preliminary efficacy of two digital interventions among 114 adolescent participants, and their parents/guardians, in reducing suicidal ideation in the adolescent participants. Adolescent participants, parent/guardian participants, and research assessors will be blinded to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: OTX-207 |
| Control | Sham comparator | Device: Comparator App + Treatment as Usual (TAU) |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patients (of any sex), ages 13 to 17 years
- Patients who were recently hospitalized and have:
- Hospitalized is defined as admission to a medical or psychiatric service for further assessment and care including observation units, intensive care or other medical units and psychiatric units.
- Patient owns a smartphone capable of downloading and running apps
- Patient is willing and able to complete enrollment procedures
Key exclusion criteria (5 listed)
- 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.
- Patients whose discharge plans include transfer to inpatient care, as confirmed by the index hospitalization discharge summary/plan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTX-207Experimental Pscyhoeducation and Intervention App | Device | Treatment |
| Comparator App + Treatment as Usual (TAU)Digitized content and information included in standard of care (i.e., TAU) | Device | Control |
Primary outcome
Scale for Suicide Ideation (SSI)
Time frame: 12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTX-207 and Comparator App + Treatment as Usual (TAU) in people with Suicidal Ideation, run by Oui Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Suicide Ideation (SSI) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.