RecruitingNAINTERVENTIONAL

Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

This study explores a new medicine called Diroximel Fumarate (DRF) for people with schizophrenia. Researchers believe a brain chemical called glutathione (GSH) might be lower in schizophrenia and could be a target for new treatments. DRF is already used for another brain condition. This research aims to see if DRF can increase GSH in the brain of people with schizophrenia, using special brain scans. They will also check if any changes in this chemical are linked to the symptoms experienced. Participants will take DRF, and some will be given a dummy pill, to compare the effects. The goal is to see if DRF could be a helpful treatment and to guide future studies.

At a glance

Status

Recruiting

Phase

Sponsor

King's College London

Enrolment target

Start

10 Jan 2025

Estimated completion

20 Jan 2027

Schizophrenia Disorders

What is this study about?

Schizophrenia is a serious mental health condition that affects about 1 in every 100 people. It can cause symptoms like hearing or seeing things that aren't there (hallucinations), false beliefs (delusions), feeling less motivated, and having trouble thinking clearly. For many, these symptoms don't go away easily, highlighting a need for better treatments.

Scientists are looking into a brain chemical called glutathione (GSH). GSH is like the body's natural antioxidant, protecting brain cells. Evidence suggests that levels of GSH might be different in people with schizophrenia. This study wants to find out if a medicine called Diroximel Fumarate (DRF), which is currently used for a different brain condition (multiple sclerosis), can increase the amount of GSH in the brains of people with schizophrenia. They will use special brain scans, similar to detailed photographs, to measure these changes.

The study also aims to see if any changes in brain GSH are connected to other measurements of brain activity and the symptoms people experience. The results will help researchers understand if DRF could be a promising treatment for schizophrenia and will guide future research into new ways to help people living with this condition.

Key takeaways

This study explores a new potential treatment (DRF) for schizophrenia.
It investigates how DRF might affect a brain chemical called glutathione (GSH).
Participation involves taking pills and having regular brain scans (MRI) and other tests.
The study includes a 'randomised' phase where participants either get DRF or a dummy pill.
Results will help guide future research into new schizophrenia treatments.
The study lasts approximately one month for each participant.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old and have a diagnosis of schizophrenia. It's important that your current antipsychotic medication dose has been stable for at least a month, and your mental health has been stable, without a relapse, for the past two months. You also need to be able to understand the study information and agree to take part.

There are several reasons why someone might not be able to join. These include having certain other serious medical conditions like HIV, cancer, or severe kidney or liver problems. If you are pregnant or breastfeeding, or if you could become pregnant and are not using effective contraception, you cannot take part. Additionally, if you are taking medications that might react badly with DRF, or if you have a high risk of suicide or are misusing substances other than cigarettes, this study might not be suitable 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 18 and 65 years old?
Do you have a diagnosis of schizophrenia?
Has your current medication dose been stable for at least a month?
Have you been mentally stable with no relapse in the last 2 months?
Are you able to understand the study and agree to take part?
Are you *not* pregnant, breastfeeding, or trying to get pregnant without effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first take the study drug, Diroximel Fumarate (DRF), for two weeks. The dose will start lower and then increase. After this, a computer will randomly decide whether you continue with DRF or switch to a dummy pill (placebo) for another two weeks. Neither you nor the study team will know which you are taking during this second phase.

Throughout the study, you'll have several appointments. These will include blood tests, questionnaires about your schizophrenia symptoms, measurements of your brain's electrical activity (EEG), and special brain scans (MRI). These assessments will be done at the beginning of the study, after the first two weeks, and again at the end of the second phase. The total duration of your active participation, including medication and assessments, would be about one month.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new potential treatment for schizophrenia and contributing to important research that could help others. However, as with any medication, there are potential risks and side effects associated with Diroximel Fumarate, which the study team will explain in detail. You might also experience side effects from the study drug, or the dummy pill may not have any positive effect on your symptoms. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

South London and Maudsley NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Department of Computer Science, Faculty of Engineering Science, University College London
Verified postcode
London, United Kingdom· Recruiting
School of Psychology, University of birmingham
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is schizophrenia?

Schizophrenia is a mental health condition that can cause symptoms like seeing or hearing things that aren't there, false beliefs, and trouble with thinking clearly and motivation.

What is glutathione (GSH)?

Glutathione (GSH) is a natural chemical in your brain that acts like an antioxidant, helping to protect your brain cells.

What is Diroximel Fumarate (DRF)?

Diroximel Fumarate (DRF) is a medicine currently used to treat another brain condition called multiple sclerosis. We are investigating if it can help with schizophrenia.

What is a 'dummy pill' (placebo)?

A dummy pill (placebo) looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the medicine.

Will I know if I'm getting the study drug or the dummy pill?

During part of the study, neither you nor the research team will know if you're taking the study drug or the dummy pill. This is standard practice in medical research to ensure fair results.

How to find out more

Violeta Perez-Rodriguez, Clinical Research Associate

violeta.perez_rodriguez@kcl.ac.uk (+44)07871777185 Official trial record

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