RecruitingNot ApplicableNCT06957808

Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia


Sponsor

King's College London

Enrollment

30 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Schizophrenia is a condition that causes symptoms like delusions, hallucinations, reduced motivation and muddled thinking. It is a common, severe and disabling psychiatric illness affecting about 1/100 (1%) of people. It is ranked the third most disabling illness worldwide. Six in seven patients do not recover from the illness in 6-12 months and continue to experience psychotic symptoms. Therefore, there is a strong unmet need for new evidence-based treatments to target the neurobiology underlying schizophrenia. There is increasing evidence to indicate that glutathione (GSH), the main brain antioxidant, is abnormal in schizophrenia and may provide a new treatment target. In this study, the investigators plan to determine whether Diroximel Fumarate (DRF) (currently a treatment for a brain disorder called multiple sclerosis) can increase GSH in the brain of patients with schizophrenia using a brain scan (MRI) and explore whether changes in GSH are related to other brain measures (measured with MRI and EEG- which measures electrical activity in the brain), blood markers of GSH, and symptoms. During this study 30 people with schizophrenia will be recruited. Participants will take the drug DRF for two weeks, a computer will then decide randomly whether each person will continue to take DRF or a placebo/dummy pill for another two weeks. During this part of the study neither the patients nor the researchers will know which type of drug the patient is taking. Brain GSH and the other measures described will be assessed before and after taking the DRF and placebo/dummy pill. At the end of the study (2027), the investigators will see if taking DRF alters the brain chemical (GSH) in people with schizophrenia and whether this is linked to other measures and symptoms. It will also give researchers information about the best way to design future studies for patients with schizophrenia using this drug.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called diroximel fumarate (DRF) — used for multiple sclerosis — can increase levels of glutathione (a natural antioxidant in the brain) in people with schizophrenia. Low glutathione is thought to contribute to brain cell damage in schizophrenia, and this drug may help restore it. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with schizophrenia (DSM-5 criteria) - You have been on a stable dose of antipsychotic medication for at least 1 month - You have been clinically stable with no relapse in the past 2 months - You are able to give informed consent **You may NOT be eligible if...** - You have a significant medical condition such as HIV, lupus, cancer, or a history of bone marrow transplant - You are currently taking medications that are known to interact with DRF - You have received live vaccines recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDiroximel fumarate (DRF)

Diroximel fumarate is an immunomodulating drug licensed for use in multiple sclerosis. It has been found to cross the blood brain barrier and increase brain glutathione levels.

DRUGPlacebo

A placebo pill given to participants.


Locations(3)

South London and Maudsley NHS Foundation Trust

London, Greater London, United Kingdom

Department of Computer Science, Faculty of Engineering Science, University College London

London, Greater London, United Kingdom

School of Psychology, University of birmingham

Birmingham, United Kingdom

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NCT06957808


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