PRIME vs Usual Care for Clinical High Risk

Clinical High Risk Syndrome for Psychosis Clinical Trial

Official title:

Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960451
• Other study ID #: 1411014943
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Clinical High Risk Syndrome for Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• PRIME care
Specialist medication, cognitive behavior therapy, family-focused therapy
• Usual care
Medication and psychotherapy as available form community providers

Locations

Country	Name	City	State
United States	Prevention through Risk Identification Management and Education (PRIME) Clinic	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Assessment of Functioning		24 months
Secondary	Service utilization	hospitalizations and emergency room use	24 months