NCT03369730

Brief Summary

The goal of this project is to investigate whether a systematic screening approach for individuals with first episode psychosis (FEP) can substantially reduce Duration of Untreated Psychosis (DUP). The study team will evaluate the feasibility of screening a consecutive help-seeking population entering mental health services in order to facilitate early identification of FEP cases, rapid referral to specialty care and engagement in treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

3.6 years

First QC Date

December 6, 2017

Last Update Submit

December 10, 2021

Conditions

Keywords

ScreeningDuration of Untreated Psychosis (DUP)Coordinated Specialty Care (CSC)First Episode Psychosis (FEP)At Risk Mental State (ARMS)Clinical High Risk for Psychosis (CHR)

Outcome Measures

Primary Outcomes (1)

  • Duration of Untreated Psychosis (DUP)

    The DUP is defined as the time, in weeks, between onset of psychotic symptoms and initiation of FEP treatment, in the case of this study, entry into Coordinated Specialty Care (CSC) programs for first episode psychosis (FEP).

    Day 1

Secondary Outcomes (5)

  • Rate of completed PQ-B screen.

    Day 1

  • Rate of completed SIPS

    Day 1

  • Rates of FEP cases

    Day 1

  • Rate of ARMS cases

    Day 1

  • Rate of CHR cases

    Day 1

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals ages 12 to 30 entering child/adolescent and adult community mental health clinics.

You may qualify if:

  • age 12- 30
  • ability to participate in assessments in English
  • ability to provide informed consent (assent for those under age 18)
  • meet criteria for psychosis or psychosis risk on SIPS

You may not qualify if:

  • previous diagnosis of schizophrenia or schizoaffective disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Trustees of Boston University

Boston, Massachusetts, 02215, United States

Location

Research Foundation/City University of New York (CUNY) on behalf of CUNY Graduate School

New York, New York, 10027, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

  • Addington J, Heinssen RK, Robinson DG, Schooler NR, Marcy P, Brunette MF, Correll CU, Estroff S, Mueser KT, Penn D, Robinson JA, Rosenheck RA, Azrin ST, Goldstein AB, Severe J, Kane JM. Duration of Untreated Psychosis in Community Treatment Settings in the United States. Psychiatr Serv. 2015 Jul;66(7):753-6. doi: 10.1176/appi.ps.201400124. Epub 2015 Jan 15.

    PMID: 25588418BACKGROUND
  • Dixon LB, Goldman HH, Bennett ME, Wang Y, McNamara KA, Mendon SJ, Goldstein AB, Choi CW, Lee RJ, Lieberman JA, Essock SM. Implementing Coordinated Specialty Care for Early Psychosis: The RAISE Connection Program. Psychiatr Serv. 2015 Jul;66(7):691-8. doi: 10.1176/appi.ps.201400281. Epub 2015 Mar 16.

    PMID: 25772764BACKGROUND
  • Rietdijk J, Klaassen R, Ising H, Dragt S, Nieman DH, van de Kamp J, Cuijpers P, Linszen D, van der Gaag M. Detection of people at risk of developing a first psychosis: comparison of two recruitment strategies. Acta Psychiatr Scand. 2012 Jul;126(1):21-30. doi: 10.1111/j.1600-0447.2012.01839.x. Epub 2012 Feb 15.

    PMID: 22335365BACKGROUND

Study Officials

  • Yulia Landa, PsyD, MS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 12, 2017

Study Start

February 19, 2018

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

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.

Locations