NCT06957808 Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia
| NCT ID | NCT06957808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Schizophrenia Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-01-10 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 informed consent Exclusion Criteria: * 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 King's 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
Contact & Investigator
Violeta Perez-Rodriguez, Clinical Research Associate
✉ violeta.perez_rodriguez@kcl.ac.uk📞 (+44)07871777185
Katherine Beck, Clinical Lecturer
PRINCIPAL INVESTIGATOR
Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience
Frequently Asked Questions
Who can join the NCT06957808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06957808 currently recruiting?
Yes, NCT06957808 is actively recruiting participants. Contact the research team at violeta.perez_rodriguez@kcl.ac.uk for enrollment information.
Where is the NCT06957808 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom, Birmingham, United Kingdom.
Who is sponsoring the NCT06957808 clinical trial?
NCT06957808 is sponsored by King's College London. The principal investigator is Katherine Beck, Clinical Lecturer at Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience. The trial plans to enroll 30 participants.
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