PRIME vs Usual Care for Clinical High Risk

Not Applicable

Completed

• Conditions: Clinical High Risk Syndrome for Psychosis
• Interventions: Other: PRIME care; Other: Usual care

• Registration Number: NCT02960451
• Lead Sponsor: Yale University

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.

Detailed Description

This study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Status Verified: 2019-05
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Subjects must meet all of the following:

  1. Male or female between 12 and 30 years old.
  2. Understand and sign an informed consent (or assent for minors) document in English.
  3. Meet diagnostic criteria for prodromal syndrome as per COPS criteria.

Read More

Exclusion Criteria

• Subjects must not meet any of the following:

  1. Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
  2. 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.
  3. Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
  4. Alcohol or substance dependence in the past 6 months.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRIME care	PRIME care	Specialized care in the PRIME clinic
Usual care	Usual care	Usual care in the community

Primary Outcome Measures

Name	Time	Method
Global Assessment of Functioning	24 months

Secondary Outcome Measures

Name	Time	Method
Service utilization	24 months	hospitalizations and emergency room use

Trial Locations

Locations (1)

Prevention through Risk Identification Management and Education (PRIME) Clinic; 🇺🇸 New Haven, Connecticut, United States