At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Diroximel fumarate (DRF) (drug), Placebo (drug)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- Diroximel fumarate (DRF) — drug: Diroximel fumarate is an immunomodulating drug licensed for use in multiple sclerosis. · Placebo — drug: A placebo pill given to participants.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 30
- Started
- 2025-01-10
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for schizophrenia disorders
- • NA - 30 participants
- • Schizophrenia is a condition that causes symptoms like delusions, hallucinations, reduced motivation and muddled thinking
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with schizophrenia disorders
Where?
- • London - South London and Maudsley NHS Foundation Trust
- • London - Department of Computer Science, Faculty of Engineering Science, University College London
- • Birmingham - School of Psychology, University of birmingham
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Study Objectives: To determine if the level of GSH in the ACC, as indexed by 1HMRS, will increase after treatment with DRF compared to baseline in patients with schizophrenia. Study Design: Participants will take DRF as open label for 2 weeks (231mg for 7 days, then increase to 462mg for another 7 days), then participants will have the option to participate in the second phase of the study, where participants will be randomly allocated to either DRF for further 2 weeks or placebo. Allocation will be double-blinded. Participants will have baseline blood tests, schizophrenia rating scales, EEG and MRI, and these will be repeated after the open label and once again after the randomised phase. 30 patients with schizophrenia will be recruited from mental health teams. Inclusion Criteria: * 18-65 years * diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders-5 (SCID) (DSM-5) * stable antipsychotic dose (no change for 1 month) * currently stable in mental state with no evidence of relapse within the last 2 months prior to study enrolment * minimum score of 60 Positive and Negative Syndrome Scale (PANSS) * capacity to provide informed consent Exclusion criteria (https://www.medicines.org.uk/emc/product/13087/smpc): * history of significant co-morbid medical or neurological disorder including but not limited to HIV, malignancies, Systemic Lupus Erythematosus, sarcoidosis, autoimmune vasculitis, bone marrow transplantation * current use of medication that is known to interact with DRF, live vaccines given within the period of DRF treatment, nephrotoxic medication (including but not limited to aminoglycosides, diuretics, non-steroidal anti-inflammatory drugs, Lithium) * contraindications to DRF (pregnancy, women of childbearing potential not currently using effective contraception (combined pill (oestrogen \& progesterone), progesterone -only with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence), breast feeding, severe hepatic impairment, moderate renal impairment, severe active gastrointestinal disease, lymphocyte count - below the Lower Limit of Normal (LLN) for the local laboratory (e.g 1.30 x109/L LLN for Viapath Kings College London), suspected or confirmed progressive multifocal leukoencephalopathy (PML), presence of risk factors for PML (previous and/or current immunosuppressant or immunomodulatory treatment (including natalizumab, other fumaric esters including Dimethyl Fumarate (DMF) (topical or systemic)), serious infection, current or recent herpes virus infection) * substance dependence/abuse other than to cigarettes * current high suicide risk * participation in a clinical study of unlicensed medicines within the previous 30 days * presence/history of other acute or chronic illness that would make participating unsafe or unsuitable, any contraindication to MRI scanning (e.g. claustrophobia, metallic implants, pacemaker, vascular clips, metal in eyes, pregnancy) * allergies to any of DRFs ingredients * taking part in a research study involving an unlicensed medicine within the last 30 days
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓18 -65 years, diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
- ✓Stable antipsychotic dose (no change for 1 month)
- ✓Currently stable with no evidence of relapse within the last 2 months prior to study enrolment
- ✓Minimum of 60 on the Positive and Negative Syndrome Scale (PANSS)
- ✓Capacity to provide agreement to take part
Who cannot take part
- ✗Substance dependence/abuse other than to cigarettes
- ✗Current high suicide risk
- ✗Participation in a clinical study of unlicensed medicines within the previous 30 days
- ✗Allergies to any of DRFs ingredients
- ✗Taking part in a research study involving an unlicensed medicine within the last 30 days
See the full criteria
Where Is This Study? (3 UK sites)
South London and Maudsley NHS Foundation Trust
London SE58AZ, United Kingdom
Department of Computer Science, Faculty of Engineering Science, University College London
London WC1E 6BT, United Kingdom
School of Psychology, University of birmingham
Birmingham B15 2TT, United Kingdom
How to Get in Touch
Violeta Perez-Rodriguez, Clinical Research Associate
Sponsor contactCONTACT
Zeryab Meyer, Clinical Research Associate
Sponsor contactCONTACT