Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06957808

Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

Led by King's College London · Updated on 2026-02-13

30

Participants Needed

3

Research Sites

105 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

R

Rosetrees Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Diagnosis of schizophrenia based on DSM-5 criteria
  • Stable antipsychotic medication dose with no changes for at least 1 month
  • Currently stable mental state with no relapse within the last 2 months
  • Minimum score of 60 on the Positive and Negative Syndrome Scale (PANSS)
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • History of significant medical or neurological disorders such as HIV, malignancies, Systemic Lupus Erythematosus, sarcoidosis, autoimmune vasculitis, or bone marrow transplantation
  • Current use of medications that interact with DRF, recent live vaccines, or nephrotoxic drugs including aminoglycosides, diuretics, NSAIDs, or Lithium
  • Contraindications to DRF including pregnancy, not using effective contraception if of childbearing potential, breast feeding, severe liver or kidney impairment, severe gastrointestinal disease, low lymphocyte count, risk factors for progressive multifocal leukoencephalopathy (PML), serious or recent infections
  • Substance dependence or abuse other than tobacco
  • High current suicide risk
  • Participation in another clinical trial with unlicensed medicines within the last 30 days
  • Any acute or chronic illness making participation unsafe or unsuitable
  • Contraindications to MRI such as claustrophobia, metallic implants, pacemaker, vascular clips, metal in eyes, or pregnancy
  • Allergies to any ingredients of DRF

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Trial Site Locations

Total: 3 locations

1

South London and Maudsley NHS Foundation Trust

London, Greater London, United Kingdom, SE58AZ

Actively Recruiting

2

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

London, Greater London, United Kingdom, WC1E 6BT

Actively Recruiting

3

School of Psychology, University of birmingham

Birmingham, United Kingdom, B15 2TT

Actively Recruiting

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Research Team

V

Violeta Perez-Rodriguez, Clinical Research Associate

CONTACT

Z

Zeryab Meyer, Clinical Research Associate

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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