Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes

First Episode Psychosis Clinical Trial

— ESPRITO  

Official title:

Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004364
• Other study ID #: 19-0307
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: July 27, 2024

Study information

• Verified date: October 2023
• Source: Northwell Health
• Contact: Patricia Marcy, BSN
• Phone: 347-439-8035
• Email: pmarcy[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

Description:

The RAISE ETP study, designed and conducted by our group, signaled that a Coordinated Specialty Care (CSC) model could be feasibly delivered in community mental health clinics in multiple states and was effective. Since then, with the support of SAMSHA block grants to states, there are CSC programs across the nation.

The goal of this project is to develop a learning health system with sites providing CSC treatment of first-episode psychosis (FEP). Sites are drawn from five states: Connecticut, Florida, Michigan, Oklahoma and South Carolina. They vary in populations served, levels of funding available and research experience. All are committed to advancing the development of CSC using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 27, 2024
• Est. primary completion date: July 27, 2024
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Enrolled in CSC program

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• First Episode Psychosis
• Schizophrenia

Intervention

Other:
• Coordinated Specialty Care (CSC)
CSC is an integrated and team-based treatment model for first episode psychosis elements include psychotherapy, supported employment and education, family education and support, and pharmacotherapy.

Locations

Country	Name	City	State
United States	Henderson Behavioral Health	Lauderdale Lakes	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Enrolled participants	Number of enrolled participants into the learning health system	5 years of the project