RecruitingPHASE4INTERVENTIONAL

Biomarkers to Enhance Early Schizophrenia Treatment

This research is for young people, aged 18-35, who are experiencing their very first episode of psychosis. The study aims to find out if specific genetic markers and brain scan results can help doctors choose the best medication for each individual. We're looking to see if these 'biomarkers' can predict who might respond well to standard treatments like aripiprazole or risperidone, and who might do better with an earlier start on clozapine. The goal is to get people the most effective treatment sooner, while also checking if they are less likely to experience common side effects like significant weight gain or a rare but serious blood problem. This could lead to more personalised and effective care for people dealing with psychosis.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Northwell Health

Enrolment target

180

Start

30 Sep 2025

Estimated completion

30 Jul 2030

Schizophenia Disorder

What is this study about?

Imagine you're unwell, and your doctor wants to find the very best medicine for you, as quickly as possible. This study is trying to do just that for young people experiencing their first episode of psychosis. Psychosis is a mental health condition where a person might have difficulty telling what's real from what's not. The usual approach is to try one medication, and if it doesn't work well enough or causes too many side effects, then switch to another. This can take time.

This research hopes to make that process faster and more effective. Scientists are looking for specific clues in your body – which they call 'biomarkers' – that could give them a head start. Think of it like a detective looking for evidence. These clues involve looking at your genes (your body's instruction manual) and how certain parts of your brain are connected, using special scans. By understanding these clues, doctors hope to predict who might respond better to certain medicines, like aripiprazole, risperidone, or another powerful medicine called clozapine. They also want to see who might be less likely to have certain side effects, like gaining a lot of weight or a very rare but serious blood issue with clozapine.

The main question of the study is: if we use these clues to pick a medicine, specifically starting clozapine earlier for some, will it lead to better outcomes compared to the usual way of finding the right medicine? The aim is to find ways to personalise treatment so that people get the most effective care right from the start, helping them recover quicker and live fuller lives.

Key takeaways

This study aims to find the best first treatment for psychosis.
It uses genetic tests and brain scans to guide medication choices.
The goal is to provide more personalised and effective care sooner.
You would be closely monitored for side effects and progress.
Your medical information is kept confidential and you can leave at any time.

Who may be eligible?

This study is particularly looking for young people, aged 18 to 35, who have recently been diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder. A key part is that you should be experiencing your very first episode of psychosis and have taken antipsychotic medications for less than four weeks in your lifetime (though there are some exceptions for very low doses used for other reasons, like sleep).

To see if you're a good fit, the study will also check certain things about your health. For example, they'll do some genetic tests and brain scans to look for specific 'biomarkers' that suggest you might respond well to a particular treatment and aren't at high risk for certain side effects. You'll also need to be able to understand the study and agree to take part.

There are some reasons why you might not be able to join. These include having certain serious existing health conditions (like some neurological or heart problems), being on other medications that could affect the study results, or having a significant risk of harming yourself or others. They also can't include people with certain substance use disorders within the last three months, or those who can't have an MRI scan (for example, if you have a pacemaker).

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 aged between 18 and 35?
Have you recently been diagnosed with a condition like schizophrenia?
Is this truly your first episode of psychosis, with less than 4 weeks of antipsychotic medication in total?
Do you not have any serious ongoing unrelated health issues?
Are you able to have an MRI scan (e.g., no pacemaker)?
Can you understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step would be a screening process. This involves a special type of brain scan called an fMRI (which looks at brain activity) and a blood test to check your genes for the specific 'biomarkers' the study is interested in. If these tests show you meet the specific criteria for the study, you would then be enrolled.

Once enrolled, you would be assigned to receive either one of the standard medications (risperidone or aripiprazole) or clozapine, based on the results of your biomarker tests. The research team would closely monitor your progress, your mental health symptoms, and any side effects you might experience. This would involve regular visits to the clinic, where you would have discussions with the medical team, and likely complete questionnaires or assessments. They would also monitor your blood for any potential side effects of the medication. The exact duration of the study isn't specified in detail, but clinical trials usually involve regular check-ups over several months to ensure safety and effectiveness.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that, if the biomarker approach works, you might receive a more tailored and effective treatment for your first episode of psychosis sooner than you would with standard approaches. This could lead to a better and quicker recovery. However, there's no guarantee that the treatment you receive in the study will be more effective for you personally, or that you won't experience side effects from the medication. All medications have potential side effects, and the study team would monitor you closely for these. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

University of California San Diego
Verified postcode
La Jolla, United States· Recruiting
McLean
Verified postcode
Belmont, United States· Recruiting
Feinstein Institute for Medical Research
Verified postcode
Glen Oaks, United States· Recruiting
Centre for Addiction and Mental Health
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'psychosis'?

Psychosis is a mental health condition where a person can have difficulty telling what's real from what's not, and might experience hallucinations or unusual beliefs.

What are 'biomarkers'?

Biomarkers are medical 'clues' – like specific genes or patterns in brain scans – that can help doctors understand a disease or how someone might respond to treatment.

Will I know which medication I'm getting?

Yes, if you're eligible for the study, your treatment will be decided based on your biomarker results, and the study team will discuss this openly with you.

Are the medications new or experimental?

The medications used in this study (aripiprazole, risperidone, clozapine) are all established and approved treatments for psychosis. The study is exploring a new way of choosing which one to use.

What if I change my mind about participating?

You are free to leave the study at any point, for any reason. Your decision will not affect your ongoing medical care.

How to find out more

Patricia Marcy

pmarcy@northwell.edu 904-302-0811 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.