PRIME vs Usual Care for Clinical High Risk

Overview

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 Title of Study: “Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 1, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: PRIME care
    • Specialized care in the PRIME clinic
  • Active Comparator: Usual care
    • Usual care in the community

Clinical Trial Outcome Measures

Primary Measures

  • Global Assessment of Functioning
    • Time Frame: 24 months

Secondary Measures

  • Service utilization
    • Time Frame: 24 months
    • hospitalizations and emergency room use

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yale University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Scott Woods, MD, Principal Investigator, Yale University

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