Suicide, AttemptedPhase 2/3NCT05144685
A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic
A Phase 2/3 study testing OTX-202, OTX-000 and Treatment as Usual in people with Suicide, Attempted and Suicidal Ideation, run by Oui Therapeutics, Inc. at 6 sites in United States.
Trial summary
The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- OTX-202, OTX-000 and Treatment as Usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Apr 2022to 14 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages ≥18 years old
- Patients recently hospitalized.
- Owns a smartphone.
- Willing and able to complete enrollment procedures.
- Able to understand the nature of the study.
- Able and willing to provide at least two verifiable contacts.
Who cannot join
- Patients who have untreated psychosis or active psychosis
- Patients who appear to be impaired by the use of alcohol or other substance(s)
- Patients who sign, or have signed, an informed consent form to participate in any clinical research
- Patients who upon clinical examination are cognitively impaired
- Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Harding Hospital
Columbus, Ohio, 43210
UCDDenver / Denver Health
Denver, Colorado, 80204
Northwell Health
Glen Oaks, New York, 11004
Yale
New Haven, Connecticut, 06511
Common Spirit
Omaha, Nebraska, 68131
About this study
Official title: A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts
The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.
Read the detailed description
This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- OTX-202, OTX-000, Treatment as Usual
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-202Device
Experimental Pscyhoeducation and Intervention App
OTX-000Device
Other Pscyhoeducation App
Treatment as UsualBehavioural
Also called TAU
Treatment as usual may include appointments with psychiatrists and other mental health clinicians, suicide risk assessment, supportive listening, crisis resources, clinician assessment, and referral to outpatient treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental App + Treatment as Usual | Experimental | This intervention will be for the treatment group Receives: Device: OTX-202; Behavioral: Treatment as Usual |
| Other App + Treatment as Usual | Experimental | This intervention will be for the control group Receives: Device: OTX-000; Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia-Suicide Severity Rating Scale(C-SSRS)
The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.
Measured: Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start7 Apr 2022
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Why it stopped: Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 356 participants (actual)
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
- NCT05144685
- Sponsor's protocol ID
- 2020-Oui-001
- Other IDs
- 2R42MH123357-02
- Status last verified
- Jun 2025
- First submitted
- 11 Nov 2021
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Bryan CJ, Simon P, Wilkinson ST, Allen MH, Perez J, Adler C, Moon K, Astorino L, Carpenter KM, Misquitta L, Brownlowe K, Khazem LR, Hay J, Starkey AG, Tartaglia J, Winston H, Simpson S, Dager AD, Feuerstein S. A Digital Therapeutic Intervention for Inpatients With Elevated Suicide Risk: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525809. doi: 10.1001/jamanetworkopen.2025.25809.
PubMed 40779267
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts
- ClinicalTrials.gov ID
- NCT05144685
- Acronym / sponsor ID
- 2020-Oui-001
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Oui Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 3 Dec 2021 (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 effectiveness of a digital intervention in reducing suicide attempts.
Detailed description
This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental App + Treatment as Usual | Experimental | Device: OTX-202, Behavioral: Treatment as UsualThis intervention will be for the treatment group |
| Other App + Treatment as Usual | Experimental | Device: OTX-000, Behavioral: Treatment as UsualThis intervention will be for the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages ≥18 years old
- Patients recently hospitalized.
- Owns a smartphone.
- Willing and able to complete enrollment procedures.
- Able to understand the nature of the study.
Key exclusion criteria (5 listed)
- Patients who have untreated psychosis or active psychosis
- Patients who appear to be impaired by the use of alcohol or other substance(s)
- Patients who sign, or have signed, an informed consent form to participate in any clinical research
- Patients who upon clinical examination are cognitively impaired
- Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete
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-202Experimental Pscyhoeducation and Intervention App | Device | Experimental App + Treatment as Usual |
| OTX-000Other Pscyhoeducation App | Device | Other App + Treatment as Usual |
| Treatment as UsualAlso: TAUTreatment as usual may include appointments with psychiatrists and other mental health clinicians, suicide risk assessment, supportive listening, crisis resources, clinician assessment, and referral to outpatient treatment. | Behavioural | Experimental App + Treatment as Usual, Other App + Treatment as Usual |
Primary outcome
Columbia-Suicide Severity Rating Scale(C-SSRS)
Time frame: Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104
The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.
Results and safety
The study was stopped early (reason given: Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 40779267Bryan CJ, Simon P, Wilkinson ST, Allen MH, Perez J, Adler C, Moon K, Astorino L, Carpenter KM, Misquitta L, Brownlowe K, Khazem LR, Hay J, Starkey AG, Tartaglia J, Winston H, Simpson S, Dager AD, Feuerstein S. A Digital Therapeutic Intervention for Inpatients With Elevated Suicide Risk: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525809. doi: 10.1001/jamanetworkopen.2025.25809.
Related trials for Suicide, Attempted
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OTX-202, OTX-000 and Treatment as Usual in people with Suicide, Attempted and Suicidal Ideation, run by Oui Therapeutics, Inc. at 6 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 6 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: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.). Results are not available in the source record.
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?
Columbia-Suicide Severity Rating Scale(C-SSRS) (time frame: Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144685, which also lists 1 linked publication.
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 12 Jun 2025.