First Episode PsychosisPhase 4NCT04046497
Artificial Intelligence to Measure Adherence to Oral Medication
A Phase 4 study testing Smartphone App in people with First Episode Psychosis, run by Northwell Health at 5 sites in United States.
Trial summary
The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Smartphone App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2020to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in a CSC program
- Prescribed an oral antipsychotic
Who cannot join
- none
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
InterAct
Grand Rapids, Michigan, 49503
Citrus Health
Hialeah, Florida, 33012
InterAct of Michigan
Kalamazoo, Michigan, 49007
Red Rock
Oklahoma City, Oklahoma, 73105
Family and Children's Services
Tulsa, Oklahoma, 74315
About this study
Official title: Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication
The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.
Read the detailed description
The challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. Determining whether a patient is adhering to medication is a challenge. Pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. In other areas of medicine such as antiretroviral treatment Direct Observation of Treatment (DOT) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. DOT is clearly not feasible in community settings. An artificial Intelligence (AI) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering DOT to support participant oral medication adherence and thereby improve outcomes. Aims of the project are: 1) to document acceptability to patients of the AI smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the AI smartphone app with participants who receive standard care.
- Conditions
- First Episode Psychosis
- Being tested
- Smartphone App, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone AppOther
artificial intelligence (AI) smartphone app to provide support for medication adherence
Usual CareOther
Usual Care provided by CSC clinic
| Study group | Role | What they receive |
|---|---|---|
| Smartphone App | Experimental | artificial intelligence (AI) smartphone app to provide support for medication adherence Receives: Other: Smartphone App |
| Usual Care | Active comparator | Usual care provided at CSC clinic Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service Utilization Report Form
Provides participant utilization of psychiatric ER visits or psychiatric hospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start20 Nov 2020
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for First Episode PsychosisStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Delbert Robinson, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046497
- Sponsor's protocol ID
- 19-0307-ZHH
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2019
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication
- ClinicalTrials.gov ID
- NCT04046497
- Acronym / sponsor ID
- 19-0307-ZHH
- Conditions
- First Episode Psychosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Posted 13 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.
Detailed description
The challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. Determining whether a patient is adhering to medication is a challenge. Pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. In other areas of medicine such as antiretroviral treatment Direct Observation of Treatment (DOT) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. DOT is clearly not feasible in community settings. An artificial Intelligence (AI) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering DOT to support participant oral medication adherence and thereby improve outcomes. Aims of the project are: 1) to document acceptability to patients of the AI smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the AI smartphone app with participants who receive standard care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone App | Experimental | Other: Smartphone Appartificial intelligence (AI) smartphone app to provide support for medication adherence |
| Usual Care | Active comparator | Other: Usual CareUsual care provided at CSC clinic |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrolled in a CSC program
- Prescribed an oral antipsychotic
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Smartphone Appartificial intelligence (AI) smartphone app to provide support for medication adherence | Other | Smartphone App |
| Usual CareUsual Care provided by CSC clinic | Other | Usual Care |
Primary outcome
Service Utilization Report Form
Time frame: 12 months
Provides participant utilization of psychiatric ER visits or psychiatric hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Smartphone App in people with First Episode Psychosis, run by Northwell Health at 5 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Service Utilization Report Form (time frame: 12 months). 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 13 Oct 2026.