CompletedNot Applicable

PRIME vs Usual Care for Clinical High Risk

United States16 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range

12 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global Assessment of Functioning

Timeframe: 24 months

Trial details

NCT IDNCT02960451

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-01

View on ClinicalTrials.gov More Clinical High Risk Syndrome for Psychosis trials