PRIME vs Usual Care for Clinical High Risk

Completed · Not applicable

Conditions studied: Clinical High Risk Syndrome for Psychosis

In brief

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.

Key facts

Study ID

NCT02960451

Run by

Yale University

People needed

16

Starts

2015-01-01

Expected to finish

2019-05-01

Last updated by the study team

2019-05-28

Who can join

Age: 12 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Prevention through Risk Identification Management and Education (PRIME) Clinic — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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