First Episode Psychosis (FEP)EaSIENCT05509998
Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication
A study testing Screening Method (SM) and Screening and Communication Method (SCM) in people with First Episode Psychosis (FEP) and Clinical High Risk for Psychosis (CHR), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first… Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- First Episode Psychosis (FEP), Clinical High Risk for Psychosis (CHR)
- What is being tested?
- Screening Method (SM) and Screening and Communication Method (SCM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Apr 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 12- 30
- ability to participate in assessments in English or Spanish
- ability to provide informed consent (assent for those under age 18)
Who cannot join
- previous diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Yulia Landa, PsyD, MS, 212-585-4658, yulia.landa@mssm.edu
Rachel Jespersen, MSW, 212-585-4641, rachel.jespersen@mssm.edu
About this study
Official title: Early Stage Identification and Engagement to Reduce the Duration of Untreated Psychosis: Evaluating the Impact of Screening and Systematic Communication
The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.
Read the detailed description
Studies find a substantial delay between the onset of psychosis and the initiation of specialty treatment for first episode psychosis (FEP), with the duration of untreated psychosis (DUP) typically over one year in the U.S. Better strategies are needed to improve identification of individuals with FEP and to rapidly engage them in Coordinated Specialty Care (CSC) aimed at restoring functioning. This study will investigate whether a U.S. adaptation of a successful detection approach from the Netherlands enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych), can reduce DUP. Researchers in the Netherlands compared screening of a consecutive help-seeking population entering mental health services to clinician referral from mental health clinics and found that screening captured significantly more individuals at clinical high risk for psychosis (CHR) and with FEP. Based on the Dutch model, within the Mount Sinai Health System in New York, the study team has piloted and established the feasibility of screening help-seeking youth entering mental health services with the aim of improving early identification of FEP cases and rapid referral to specialty care (Early Stage Identification and Engagement to Reduce DUP study (EaSIE), supported by NIMH R34). Individuals entering services are screened with the Prodromal Questionnaire-Brief Version (PQ-B). Those who screen positive are assessed by Structured Interview for Psychosis Risk Syndromes (SIPS) and referred to stage-specific specialty care (FEP or CHR services). To facilitate service engagement the study team developed, piloted, and established feasibility of the ComPsych model, a standardized training program for clinicians in delivering information about schizophrenia, psychosis and CHR to patients and families. The ComPsych model was developed based on qualitative studies with multiple stakeholders, which have shown that family involvement and clear communication about diagnosis are critical components to successful engagement in treatment and adherence to treatment recommendations. ComPsych aims to convey sensitive information in a way that promotes understanding, empathy, and a sense of ongoing support.
The objective of this project is to investigate whether a systematic screening approach enhanced by ComPsych can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. This study will use a Hybrid Type 1 randomized controlled trial design (RCT) to test the effectiveness of SCM vs SM and to examine multi-level implementation factors that can inform the identification of implementation strategies for future deployment of SCM in routine practice. This study team will use a stepped-wedge cluster RCT design to compare SCM to SM to evaluate whether SCM substantially reduces DUP. The study hypotheses are: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services; (3) ComPsych targets (understanding of psychosis, stigma, attitudes about treatment) will mediate the impact of SCM on DUP. The study team will also conduct a multi-level qualitative implementation study informed by the Consolidated Framework for Implementation Research (CFIR) to first examine implementation barriers and facilitators and then apply the Expert Recommendations for Implementing Change (ERIC) taxonomy of implementation strategies to these findings to help select potential implementation strategies for SCM and SM. Data will be collected from clinicians and administrators before the implementation of the trial (year 1) and after recruitment for the trial has ended (year 4), and from patients and families throughout the project.
The knowledge gathered from this project is of significant public health relevance as it has potential to facilitate more rapid and timely detection and treatment of first episode psychosis (FEP) by evaluating the utility of systematic screening and communication strategies for psychotic symptoms.
- Being tested
- Screening Method (SM), Screening and Communication Method (SCM)
- Keywords
- Duration of Untreated Psychosis (DUP), Screening, Communication, First Episode Psychosis (FEP), Clinical High Risk for Psychosis (CHR), Coordinated Specialty Care
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening Method (SM)Behavioural
All consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate.
Screening and Communication Method (SCM)Behavioural
Clinicians will be trained to discuss findings and provide referrals using the ComPsych model. ComPsych prepares clinicians to effectively communicate diagnostic, prognostic and treatment information about FEP and CHR with patients and families, using a model that instils realistic hope and provides information effectively to encourage shared decision making about treatment. All consecutive patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Following the evaluation, the clinician will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty services, as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Screening Method (SM) | Active comparator | In the SM condition all consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs. Receives: Behavioral: Screening Method (SM) |
| Screening and Communication Method (SCM) | Experimental | In the SCM condition, the same screening and evaluation procedures described above will continue, but clinicians conducting evaluations and making referrals will be trained to discuss findings and provide referrals using the ComPsych model. Following the evaluation, the clinician who conducted the evaluation will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty FEP or CHR services, as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs. Receives: Behavioral: Screening and Communication Method (SCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of untreated psychosis (DUP)
The DUP is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and initiation of FEP treatment (date of intake into Coordinated Specialty Care (CSC) programs for first episode psychosis.
Measured: up to 2 years
Secondary outcomes (8)
Duration of unrecognized illness (DUI)
The DUI is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and evaluation with the SIPS.
Measured: Baseline
Number of individuals initiating FEP services
Number of individuals initiating FEP services
Measured: up to 4 years
Number of individuals initiating CHR services
Number of individuals initiating CHR services
Measured: up to 4 years
Patient Satisfaction with Consultation Questionnaire (PSC)
This 22-item measure uses a 5-point Likert scale to measure satisfaction with amount/quality of information presented, emotional support and level of patient and family participation. The PSC has high internal reliability (Cronbach's Alpha .91). Used extensively in cancer studies, it is sensitive to differences in consultant behavior. For the purposes of this study, 4 items were removed. PSC will be administered to patients and family members in both SCM and SM conditions after a consultation where SIPS feedback is provided and referral made (in SCM ComPsych model will be used).
Full scale from 18 - 90, with higher score indicating greater satisfaction
Measured: Month 1
Knowledge About Schizophrenia Test (KAST)
A self-report scale adapted from the Knowledge About Schizophrenia Test (KAST) to assess understanding of psychosis. KAST is an 18 item instrument, full scale range from 1-18, higher score indicates more knowledge.
Measured: Month 1
Stigma Scale (SS)
28-item Stigma Scale (SS) Full scale from 28 - 140, higher score indicates higher impact of stigma
Measured: Month 1
Attitudes about treatment
Patients will be asked how much they agree (on a 5-point likert scale) with the statement: "I intend to go to my initial appointment at [name of program referred to]" Score from 1-5, with higher score indicating more agreement.
Measured: Month 1
Attitudes about treatment
Patients will be asked how much they agree (on a 5-point likert scale) with the statement: "I think [program] is likely to help me with my problems". Score from 1-5, with higher score indicating more agreement.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode Psychosis (FEP)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Cluster Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Yulia Landa, Icahn School of Medicine at Mount Sinai
- Investigators
- Yulia Landa, PsyD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509998
- Sponsor's protocol ID
- GCO 21-1631
- Other IDs
- 1R01MH130354-01
- Acronym
- EaSIE
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with NIH policy, a de-identified dataset will be uploaded to the NIMH Data Archive: the National Database for Clinical Trials Related to Mental Illness.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stage Identification and Engagement to Reduce the Duration of Untreated Psychosis: Evaluating the Impact of Screening and Systematic Communication
- ClinicalTrials.gov ID
- NCT05509998
- Acronym / sponsor ID
- EaSIE / GCO 21-1631
- Keywords
- Duration of Untreated Psychosis (DUP), Screening, Communication, First Episode Psychosis (FEP), Clinical High Risk for Psychosis (CHR), Coordinated Specialty Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 22 Aug 2022 (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 goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.
Detailed description
Studies find a substantial delay between the onset of psychosis and the initiation of specialty treatment for first episode psychosis (FEP), with the duration of untreated psychosis (DUP) typically over one year in the U.S. Better strategies are needed to improve identification of individuals with FEP and to rapidly engage them in Coordinated Specialty Care (CSC) aimed at restoring functioning. This study will investigate whether a U.S. adaptation of a successful detection approach from the Netherlands enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych), can reduce DUP. Researchers in the Netherlands compared screening of a consecutive help-seeking population entering mental health services to clinician referral from mental health clinics and found that screening captured significantly more individuals at clinical high risk for psychosis (CHR) and with FEP. Based on the Dutch model, within the Mount Sinai Health System in New York, the study team has piloted and established the feasibility of screening help-seeking youth entering mental health services with the aim of improving early identification of FEP cases and rapid referral to specialty care (Early Stage Identification and Engagement to Reduce DUP study (EaSIE), supported by NIMH R34). Individuals entering services are screened with the Prodromal Questionnaire-Brief Version (PQ-B). Those who screen positive are assessed by Structured Interview for Psychosis Risk Syndromes (SIPS) and referred to stage-specific specialty care (FEP or CHR services). To facilitate service engagement the study team developed, piloted, and established feasibility of the ComPsych model, a standardized training program for clinicians in delivering information about schizophrenia, psychosis and CHR to patients and families. The ComPsych model was developed based on qualitative studies with multiple stakeholders, which have shown that family involvement and clear communication about diagnosis are critical components to successful engagement in treatment and adherence to treatment recommendations. ComPsych aims to convey sensitive information in a way that promotes understanding, empathy, and a sense of ongoing support.
The objective of this project is to investigate whether a systematic screening approach enhanced by ComPsych can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. This study will use a Hybrid Type 1 randomized controlled trial design (RCT) to test the effectiveness of SCM vs SM and to examine multi-level implementation factors that can inform the identification of implementation strategies for future deployment of SCM in routine practice. This study team will use a stepped-wedge cluster RCT design to compare SCM to SM to evaluate whether SCM substantially reduces DUP. The study hypotheses are: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services; (3) ComPsych targets (understanding of psychosis, stigma, attitudes about treatment) will mediate the impact of SCM on DUP. The study team will also conduct a multi-level qualitative implementation study informed by the Consolidated Framework for Implementation Research (CFIR) to first examine implementation barriers and facilitators and then apply the Expert Recommendations for Implementing Change (ERIC) taxonomy of implementation strategies to these findings to help select potential implementation strategies for SCM and SM. Data will be collected from clinicians and administrators before the implementation of the trial (year 1) and after recruitment for the trial has ended (year 4), and from patients and families throughout the project.
The knowledge gathered from this project is of significant public health relevance as it has potential to facilitate more rapid and timely detection and treatment of first episode psychosis (FEP) by evaluating the utility of systematic screening and communication strategies for psychotic symptoms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Screening Method (SM) | Active comparator | Behavioral: Screening Method (SM)In the SM condition all consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs. |
| Screening and Communication Method (SCM) | Experimental | Behavioral: Screening and Communication Method (SCM)In the SCM condition, the same screening and evaluation procedures described above will continue, but clinicians conducting evaluations and making referrals will be trained to discuss findings and provide referrals using the ComPsych model. Following the evaluation, the clinician who conducted the evaluation will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty FEP or CHR services, as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 12- 30
- ability to participate in assessments in English or Spanish
- ability to provide informed consent (assent for those under age 18)
Key exclusion criteria (1 listed)
- previous diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.
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 |
|---|---|---|
| Screening Method (SM)All consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate. | Behavioural | Screening Method (SM) |
| Screening and Communication Method (SCM)Clinicians will be trained to discuss findings and provide referrals using the ComPsych model. ComPsych prepares clinicians to effectively communicate diagnostic, prognostic and treatment information about FEP and CHR with patients and families, using a model that instils realistic hope and provides information effectively to encourage shared decision making about treatment. All consecutive patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Following the evaluation, the clinician will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty services, as appropriate. | Behavioural | Screening and Communication Method (SCM) |
Primary outcome
Duration of untreated psychosis (DUP)
Time frame: up to 2 years
The DUP is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and initiation of FEP treatment (date of intake into Coordinated Specialty Care (CSC) programs for first episode psychosis.
8 secondary outcomes
Duration of unrecognized illness (DUI)
Time frame: Baseline
Number of individuals initiating FEP services
Time frame: up to 4 years
Number of individuals initiating CHR services
Time frame: up to 4 years
Patient Satisfaction with Consultation Questionnaire (PSC)
Time frame: Month 1
Knowledge About Schizophrenia Test (KAST)
Time frame: Month 1
Stigma Scale (SS)
Time frame: Month 1
Attitudes about treatment
Time frame: Month 1
Attitudes about treatment
Time frame: Month 1
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 18 Sep 2026.
- Individual participant dataSharing planned: Yes. In accordance with NIH policy, a de-identified dataset will be uploaded to the NIMH Data Archive: the National Database for Clinical Trials Related to Mental Illness.
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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.
Yulia Landa, PsyD, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Method (SM) and Screening and Communication Method (SCM) in people with First Episode Psychosis (FEP) and Clinical High Risk for Psychosis (CHR), run by Icahn School of Medicine at Mount Sinai at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Yulia Landa, PsyD, MS (212-585-4658, yulia.landa@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of untreated psychosis (DUP) (time frame: up to 2 years). 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 18 Sep 2026.