Active not recruitingOBSERVATIONAL

AMP SCZ® Observational Study: PREDICT-DPACC

This international study, called AMP SCZ, wants to find better ways to predict who is at risk of developing psychosis. They are bringing together experts from around the world to look at many different factors, including health measures and thinking tests. The main aim is to create tools that can identify young people (aged 12-30) who are most likely to develop psychosis, might get better on their own, or have ongoing milder symptoms. This will help doctors offer the right support and treatments much earlier. The study involves a large group of high-risk young people and some healthy volunteers, over a period of 18-24 months.

At a glance

Status

Active not recruiting

Sponsor

Brigham and Women's Hospital

Enrolment target

2,617

Start

02 Jun 2022

Estimated completion

30 Apr 2027

Clinical High Risk Psychosis Remission Conversion

What is this study about?

Imagine being able to understand and predict someone's journey with mental health challenges much earlier. That's what this big international study, called AMP SCZ (Accelerating Medicines Partnership Schizophrenia), hopes to achieve for young people at risk of psychosis. Psychosis is a serious mental health condition where someone might experience distorted thoughts or perceptions, and it can be very distressing.

Currently, it's hard to know exactly who among those at high risk will go on to develop psychosis, who will recover, or who might experience milder, ongoing symptoms. This study aims to change that. Researchers are combining information from many different tests – like health checks, brain scans, and thinking exercises – to develop clever computer programs. These programs will help predict what might happen to people at high risk, so doctors can offer the best possible support and treatment as early as possible. This is a bit like finding early warning signs in other health conditions, allowing for quicker action.

This important project brings together experts from many countries and involves two large research groups. They plan to enrol nearly 2,000 young people aged 12 to 30 who are at high risk of psychosis, along with over 600 healthy volunteers. Participants will be cared for by 42 different study centres across 13 countries. By gathering and analysing all this information, the study hopes to make a real difference in how we understand and help young people who might develop psychosis.

Key takeaways

This study helps understand and predict psychosis risk in young people.
It involves young people (12-30) at high risk and healthy volunteers.
No new medication is given; it's an observational study.
Participation lasts 1.5 to 2 years with various assessments.
Information is used to develop better early prediction tools.
You can withdraw at any time.

Who may be eligible?

This study is looking for young people aged between 12 and 30 years old. To take part, you would need to be considered at a 'clinical high risk' for psychosis. This means that doctors have identified certain signs or symptoms that suggest you might be more likely to develop psychosis, but you haven't actually had a full psychotic episode yet. You would also need to be able to understand and sign a consent form, or have a parent/guardian sign for you if you're under 16.

There are some reasons why you might not be able to join. For example, if you've already had a full psychotic episode that was treated with medication, or if you're currently taking certain antipsychotic medications, you wouldn't be eligible. Also, if you have certain other medical conditions affecting your brain, like a significant head injury or a learning disability, you wouldn't be able to participate. The research team will carefully check all of these points with you to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 30 years old?
Have doctors said you might be at 'high risk' for psychosis, but you haven't had a full psychotic episode?
Can you or your parent/guardian understand and sign a consent form?
Have you NOT had a significant head injury or certain other brain conditions?
Have you NOT been treated for a full psychotic episode or taken certain antipsychotic medicines for long?
Do you NOT have a diagnosed learning disability?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect:

**For young people at high risk:** You'll have an initial check-up and then undergo several assessments over 18 to 24 months. These assessments might include talking to doctors, answering questions about how you're feeling and your thinking, having some medical checks (like blood tests or brain scans), and completing cognitive tests (like puzzles or memory games). The number of visits and specific tests will be explained to you in detail.

**For healthy volunteers:** You will have an initial check-up and assessments. A smaller group will also have follow-up visits at 2, 12, and 24 months, which will be similar to the initial assessments but fewer in number. You will not be given any study medication as part of this research, as it is an 'observational' study (meaning researchers are just observing and collecting information).

Potential risks and benefits

Taking part in any study has potential benefits and risks. A key benefit of this study is that it helps us learn more about preventing and treating psychosis, which could help many young people in the future. You might also find being closely monitored helpful, and you'll receive careful assessments of your mental health. However, there's always a chance that the tests or questions might make you feel uncomfortable or distressed. All information you provide will be kept confidential. Remember, you can decide to stop participating at any time for any reason, without it affecting your care.

Locations (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California Irvine
Verified postcode
Irvine, United States
University of California Los Angeles
Verified postcode
Los Angeles, United States
University of California San Diego
Verified postcode
San Diego, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Hartford Healthcare
Verified postcode
Hartford, United States
Yale University/Connecticut Mental Health Center
Verified postcode
New Haven, United States
University of Georgia
Verified postcode
Athens, United States
Northwestern University
Verified postcode
Evanston, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
Washington University
Verified postcode
St Louis, United States
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States
Northwell Health
Verified postcode
Queens, United States

Common questions

What is 'clinical high risk' for psychosis?

It means doctors have noticed some early signs or symptoms that suggest you might be more likely to develop psychosis, but you haven't experienced a full psychotic episode yet.

Will I receive new medication in this study?

No, this is an 'observational' study, meaning researchers are just collecting information to learn more. You won't be given any new medications as part of the study.

How long will the study go on for me?

If you're at high risk, your participation will last about 18 to 24 months with several assessments. If you're a healthy volunteer, you'll have an initial assessment, and some will have follow-up visits at 2, 12, and 24 months.

What kind of tests will I have?

You might have conversations with doctors, answer questionnaires, have some medical checks (like blood tests), and do some thinking or memory games.

Is my information kept private?

Yes, all the information collected about you will be kept strictly confidential and your privacy will be protected.