PRIME vs Usual Care for Clinical High Risk

Yale University

Status

Completed

Conditions

Clinical High Risk Syndrome for Psychosis

Treatments

Other: Usual care

Other: PRIME care

Study type

Interventional

Funder types

Other

Identifiers

NCT02960451

1411014943

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

12 to 30 years old

Volunteers

No Healthy Volunteers

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.