Clinical High Risk Syndrome for PsychosisNCT02960451
PRIME vs Usual Care for Clinical High Risk
A study testing PRIME care in people with Clinical High Risk Syndrome for Psychosis, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Clinical High Risk Syndrome for Psychosis
- What is being tested?
- PRIME care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention through Risk Identification Management and Education (PRIME) Clinic
New Haven, Connecticut, 06519
About this study
Official title: Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis
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.
Read the 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.
- Being tested
- PRIME care, Usual care
- Keywords
- prodrome, cognitive behavioral therapy, family focused therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME careOther
Specialist medication, cognitive behavior therapy, family-focused therapy
Usual careOther
Medication and psychotherapy as available form community providers
| Study group | Role | What they receive |
|---|---|---|
| PRIME care | Experimental | Specialized care in the PRIME clinic Receives: Other: PRIME care |
| Usual care | Active comparator | Usual care in the community Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Functioning
Measured: 24 months
Secondary outcomes (1)
Service utilization
hospitalizations and emergency room use
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJan 2015
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk Syndrome for PsychosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Woods, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960451
- Sponsor's protocol ID
- 1411014943
- Status last verified
- May 2019
- First submitted
- 7 Nov 2016
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis
- ClinicalTrials.gov ID
- NCT02960451
- Acronym / sponsor ID
- 1411014943
- Keywords
- prodrome, cognitive behavioral therapy, family focused therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRIME care | Experimental | Other: PRIME careSpecialized care in the PRIME clinic |
| Usual care | Active comparator | Other: Usual careUsual care in the community |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects must meet all of the following:
Key exclusion criteria (5 listed)
- Subjects must not meet any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRIME careSpecialist medication, cognitive behavior therapy, family-focused therapy | Other | PRIME care |
| Usual careMedication and psychotherapy as available form community providers | Other | Usual care |
Primary outcome
Global Assessment of Functioning
Time frame: 24 months
1 secondary outcome
Service utilization
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Woods, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRIME care in people with Clinical High Risk Syndrome for Psychosis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Assessment of Functioning (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.