National Schizophrenia Awareness Day: Exploring new approaches in early psychosis research

National Schizophrenia Awareness Day is a moment to reflect on the experiences of people living with schizophrenia and related conditions, and to highlight the importance of research in improving care and support.

In recognition of this, researchers from our Clinical Trials Unit (CTU) in the Nuffield Department of Primary Care Health Sciences are collaborating with the University of Oxford’s Department of Psychiatry and NHS partners to launch a new trial aimed at improving cognitive outcomes for people experiencing early psychosis. This stage of illness offers a vital opportunity to intervene and shape recovery pathways. The trial, called FOCUS, has just been submitted for ethics and regulatory approval.

Why this research matters

Psychotic disorders, such as schizophrenia, are characterised by symptoms like hallucinations and delusions, but cognitive difficulties such as memory and concentration problems often have a longer lasting impact on daily life. Current treatments primarily focus on reducing distressing symptoms, while cognitive challenges can remain unaddressed.

Our trial focuses on early psychosis, a period where treatment may be most beneficial.  By improving understanding and treatment options, we hope to generate evidence that can inform care at these critical points.

Collaboration across teams

This trial is a collaboration between the Primary Health Care Clinical Trials Unit and the Department of Psychiatry at the University of Oxford (Associate Professor Robert McCutcheon is the study’s CI). Participant recruitment will take place at Oxford Health NHS Foundation Trust and South London and Maudsley NHS Foundation Trust, in conjunction with King’s College London.

Shaped by Patient Voices

Our trial design has been developed with members of a committed public and patient involvement (PPI) group, whose perspectives have helped shape trial procedures, materials, and research priorities. This includes that ensuring treatment acceptability - how manageable and tolerable participants find the medication and trial procedures - is directly considered as part of the study’s outcome measures.

What are we investigating?

The trial will compare a novel investigational medicine, which has received FDA approval for use in the United States - against current standard treatments. The primary objective is to assess whether this approach leads to greater improvements in cognitive performance after six weeks of treatment.

Alongside this, we will explore a range of secondary outcomes, including:

• Changes in psychosis symptoms and side effects
• Impacts on day-to-day functioning and wellbeing
• Brain biomarker patterns
• Whether biological measures at baseline can help predict treatment responses

Who is taking part?

We aim to recruit 150 participants with early psychosis, along with a separate group of 30 control participants. People with early psychosis will be randomly assigned to one of two treatment options, while control participants will help provide important reference data through cognitive assessments and brain scans. This trial will help us better understand how treatment affects cognitive performance and brain function, compared to individuals not currently experiencing psychosis.

Recruitment is expected to run from November 2025 until March 2029.

What happens next?

With the Ethics and MHRA review beginning, recruitment is scheduled to begin later this year via clinical services and community mental health teams across both sites, and with the aim of setting up a number of participant identification centres.

As the research is designed to answer important clinical questions about the role of a potential treatment in early psychosis, the findings will help guide future care, although as with any study, outcomes will only become clear once the data are collected and analysed.

We look forward to sharing updates on the trial’s progress as it moves through approvals and into recruitment.