Effect of Diroximel Fumarate on Brain Antioxidant Levels in Schizophrenia
Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia
This study is testing if a medication called Diroximel Fumarate can boost brain antioxidant levels in people with schizophrenia to see if it helps their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Drugs / interventions | natalizumab |
| Locations | 3 sites (London, Greater London and 2 other locations) |
| Trial ID | NCT06957808 on ClinicalTrials.gov |
What this trial studies
This study investigates whether Diroximel Fumarate (DRF), a treatment for multiple sclerosis, can increase levels of glutathione (GSH) in the brains of patients with schizophrenia. Participants aged 18-65 with a stable diagnosis of schizophrenia will undergo a two-week open-label treatment with DRF, followed by a randomized, double-blind phase where they will receive either DRF or a placebo for an additional two weeks. The study will utilize MRI and other assessments to measure changes in GSH and related brain functions. The aim is to explore the potential of DRF as a new treatment target for schizophrenia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a stable diagnosis of schizophrenia and no recent relapses.
Not a fit: Patients with significant co-morbid medical or neurological disorders or those currently on medications that interact with DRF may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new evidence-based treatment option for patients with schizophrenia.
How similar studies have performed: While the approach of targeting glutathione in schizophrenia is novel, other studies have explored similar neurobiological targets with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, Greater London and 2 other locations
- South London and Maudsley NHS Foundation Trust — London, Greater London, United Kingdom (Recruiting)
- Department of Computer Science, Faculty of Engineering Science, University College London — London, Greater London, United Kingdom (Recruiting)
- School of Psychology, University of birmingham — Birmingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Katherine Beck, Clinical Lecturer — Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience
- Study coordinator: Violeta Perez-Rodriguez, Clinical Research Associate
- Email: violeta.perez_rodriguez@kcl.ac.uk
- Phone: (+44)07871777185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.