RecruitingNAINTERVENTIONAL

Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk

This study is looking at young adults (18-40) who might be at risk of developing psychosis. Psychosis is a mental health condition, and current treatments don't help everyone. This research aims to see if a medicine called levetiracetam, often used for epilepsy, can help balance brain activity in a specific area linked to psychosis. Using special brain scans (MRI), we will examine if this medicine can reduce overactivity in a brain part called the hippocampus and improve thinking and memory. The study hopes to find new ways to understand and treat psychosis early.

At a glance

Status

Recruiting

Phase

Sponsor

King's College London

Enrolment target

Start

19 Jul 2024

Estimated completion

01 Feb 2026

Psychosis

What is this study about?

This research is looking into a mental health condition called psychosis, which affects about 3 in 100 people at some point in their lives. While there are treatments available, they don't work for everyone, and some symptoms are not fully addressed. This study particularly focuses on a part of the brain called the hippocampus, which looks and acts differently in people with psychosis or those at risk.

Scientists believe this difference, especially an overactivity in the hippocampus, might be linked to problems with thinking and memory. This overactivity could be due to an imbalance in how brain cells send signals. Ideally, brain cells need a good balance between 'exciting' signals (which make them send more messages) and 'inhibiting' signals (which make them send fewer messages) to work correctly.

The study will test a medicine called levetiracetam, which is already used to treat epilepsy and is known to help balance these brain signals. Researchers will use detailed brain scans (MRI) to see if levetiracetam can reduce this overactivity in the hippocampus, change how different brain areas connect, and alter levels of brain chemicals in people at risk of psychosis. The goal is to gain valuable knowledge that could lead to new and better ways to understand and treat psychosis earlier.

Key takeaways

The study explores a new way to understand and potentially treat psychosis.
It tests a medicine called levetiracetam, currently used for epilepsy.
Researchers will use safe MRI brain scans to look at brain activity.
Participation involves screening and two scanning visits over a few months.
The study aims to improve future treatments for psychosis.
You can withdraw at any time without affecting your care.

Who may be eligible?

This study is looking for two main groups of people. The first group includes young adults, aged 18 to 40, who have been identified by the Outreach and Support in South London (OASIS) teams as being at risk of psychosis. For this group, we're particularly interested if you're experiencing some unusual thoughts or ideas, as assessed by a specialist.

However, you wouldn't be able to join if you've already had a full episode of psychosis, or if you're currently taking certain medications like strong tranquillisers (benzodiazepines), epilepsy medicines, mood stabilisers, or certain sleep aids. We also can't include you if you have a known brain condition like epilepsy, are pregnant or breastfeeding, have severe kidney problems, are allergic to levetiracetam, or can't have an MRI scan for medical reasons.

The second group is for healthy individuals, also aged 18 to 40, from the Greater London area. For this group, you cannot have any personal history of mental health conditions, or a close family member (like a parent or sibling) with a psychotic disorder. Like the other group, you also can't be pregnant, breastfeeding, or trying to get pregnant, or be taking certain medications, or have a brain condition, or be unable to have an MRI.

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 18 and 40 years old?
Have you been identified as at risk of psychosis by OASIS teams?
Are you able to have an MRI scan (e.g., no pacemakers, certain metal implants)?
Are you NOT currently pregnant or breastfeeding?
Are you NOT taking certain medications like strong tranquillisers or other epilepsy drugs?
Have you NOT had a full episode of psychosis in the past?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve a few visits over 2-3 months. First, you'll have a screening visit at the Institute of Psychiatry, Psychology & Neuroscience. This will involve answering questions about your experiences and feelings, doing some thinking and memory tests, and having a blood test. This visit will last about 2 hours.

Then, for those at risk of psychosis, you will have two scanning visits at the Centre for Neuroimaging Sciences. On each of these days, you'll take either a capsule of the study medicine (levetiracetam) or a dud capsule (placebo – which looks the same but contains no active medicine). The order of these will be decided by chance. After taking the capsule, you will have a 60-minute MRI scan. This scan is completely safe and helps us look at blood flow, brain activity, and brain chemicals. You won't know if you're taking the active medicine or the placebo, and neither will the researchers, until after the study is complete.

Healthy volunteers will also have a screening visit (about 1.5 hours) and one scanning visit. You will not take any medicine and will only have the MRI scan to help us compare brain activity with the other group.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information we gather could help us better understand and treat psychosis in the future. Levetiracetam is a well-known epilepsy medicine, but like all medicines, it can have side effects. You will be told about these in detail before you agree to take part. The MRI scans are generally very safe, but if you have any metal in your body or certain medical conditions, it might not be suitable for you. You are free to withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

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

Institute of Psychiatry, Psychology and Neuroscience, King's College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body, including your brain. It does not use X-rays or radiation.

What is 'placebo'?

A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine fairly.

Will I know if I'm taking the real medicine or the placebo?

No, neither you nor the study team will know whether you receive the active medicine or placebo until after the study is finished. This is called 'double-blind'.

What does 'at risk of psychosis' mean?

It means you've been identified as having certain experiences or changes that suggest you might have a higher chance of developing psychosis in the future, but it doesn't mean you will definitely develop it.

Who is funding this research?

This study is funded by the Wellcome Trust, a health research charity, and is being run by researchers at King's College London.

How to find out more

Abigail A Gee, MBChB MSc

abigail.gee@kcl.ac.uk Official trial record

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