NCT02960451

Brief Summary

The purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

4.3 years

First QC Date

November 7, 2016

Last Update Submit

May 23, 2019

Conditions

Clinical High Risk Syndrome for Psychosis

Keywords

prodromecognitive behavioral therapyfamily focused therapy

Outcome Measures

Primary Outcomes (1)

  • Global Assessment of Functioning

    24 months

Secondary Outcomes (1)

  • Service utilization

    24 months

Study Arms (2)

PRIME care

EXPERIMENTAL

Specialized care in the PRIME clinic

Other: PRIME care

Usual care

ACTIVE COMPARATOR

Usual care in the community

Other: Usual care

Interventions

PRIME careOTHER

Specialist medication, cognitive behavior therapy, family-focused therapy

PRIME care
Usual careOTHER

Medication and psychotherapy as available form community providers

Usual care

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects must meet all of the following:
  • Male or female between 12 and 30 years old.
  • Understand and sign an informed consent (or assent for minors) document in English.
  • Meet diagnostic criteria for prodromal syndrome as per COPS criteria.

You may not qualify if:

  • Subjects must not meet any of the following:
  • Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
  • Impaired intellectual functioning (full-scale IQ\<70). However, those with an IQ in the 65-69 range will not be excluded if they score \>75 on the WRAT Reading.
  • Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
  • Alcohol or substance dependence in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention through Risk Identification Management and Education (PRIME) Clinic

New Haven, Connecticut, 06519, United States

Location

Study Officials

  • Scott Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

January 1, 2015

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)