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PRIME vs Usual Care for Clinical High Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02960451
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Clinical High Risk Syndrome for Psychosis Other: PRIME care Other: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis
Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PRIME care
Specialized care in the PRIME clinic
Other: PRIME care
Specialist medication, cognitive behavior therapy, family-focused therapy

Active Comparator: Usual care
Usual care in the community
Other: Usual care
Medication and psychotherapy as available form community providers

Primary Outcome Measures :
  1. Global Assessment of Functioning [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Service utilization [ Time Frame: 24 months ]
    hospitalizations and emergency room use

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02960451

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Contact: Barbara Walsh, PhD 2039747052

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United States, Connecticut
Prevention through Risk Identification Management and Education (PRIME) Clinic Recruiting
New Haven, Connecticut, United States, 06519
Contact: Barbara Walsh, PhD    866-287-7463   
Principal Investigator: Scott W. Woods, MD         
Sponsors and Collaborators
Yale University
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Principal Investigator: Scott Woods, MD Yale University

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Responsible Party: Yale University Identifier: NCT02960451     History of Changes
Other Study ID Numbers: 1411014943
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yale University:
cognitive behavioral therapy
family focused therapy

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders