PRIME vs Usual Care for Clinical High Risk

NCT ID: NCT02960451

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical High Risk Syndrome for Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRIME care

Specialized care in the PRIME clinic

Group Type EXPERIMENTAL

PRIME care

Intervention Type OTHER

Specialist medication, cognitive behavior therapy, family-focused therapy

Usual care

Usual care in the community

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Medication and psychotherapy as available form community providers

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRIME care

Specialist medication, cognitive behavior therapy, family-focused therapy

Intervention Type OTHER

Usual care

Medication and psychotherapy as available form community providers

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Scott Woods, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prevention through Risk Identification Management and Education (PRIME) Clinic

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1411014943

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AMP SCZ® Observational Study: PREDICT-DPACC
NCT05905003 ACTIVE_NOT_RECRUITING
mHealth for Psychosis Help-seeking
NCT05905601 COMPLETED NA