Early-Phase Schizophrenia: Practice-based Research to Imp... | NCT04004364

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

NCT04004364

Sponsor

Northwell Health

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

First Episode Psychosis

Interventions

Coordinated Specialty Care (CSC)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Jun 28, 2019

First Submission Date that Met QC Criteria

Jun 28, 2019

First Posted Date

Jul 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2024

Last Update Posted Date

Sep 19, 2024Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coordinated Specialty Care (CSC)	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Enrolled participants	Number of enrolled participants into the learning health system	5 years of the project

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Enrolled in CSC program

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

15 to 40 year olds with first episode psychosis enrolled in network CSC program

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Marcy, BSN	Contact	347-439-8035		pmarcy@northwell.edu
Cristina Gonzalez, MS	Contact	347-804-3605

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henderson Behavioral Health	Recruiting	Lauderdale Lakes	Florida	33319	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided