[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589699":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":104,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":36,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":54,"whyStopped":36,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"King's College London","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Open label","EXPERIMENTAL","Participants take the research drug for 14 days in an open label phase.",[13],"Drug: Diroximel fumarate (DRF)",{"label":15,"type":16,"description":17,"interventionNames":18},"Double-blind - DRF","ACTIVE_COMPARATOR","After open label phase, participants can be randomised to either the research drug (diroximel fumarate, DRF) or placebo for a further 2 weeks.",[13],{"label":20,"type":21,"description":17,"interventionNames":22},"Double blind - Placebo","PLACEBO_COMPARATOR",[23],"Drug: Placebo",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Diroximel 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.",[15,9],[31],"Vumerity",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Placebo","A placebo pill given to participants.",[20],null,[38],{"name":39,"affiliation":40,"role":41},"Katherine Beck, Clinical Lecturer","Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":36,"email":47},"Violeta Perez-Rodriguez, Clinical Research Associate","CONTACT","(+44)07871777185","violeta.perez_rodriguez@kcl.ac.uk",{"name":49,"role":45,"phone":36,"phoneExt":36,"email":50},"Zeryab Meyer, Clinical Research Associate","zeryab.meyer@kcl.ac.uk",[52,79,90],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"South London and Maudsley NHS Foundation Trust","RECRUITING","London","Greater London","SE58AZ","United Kingdom","UK",{"type":61,"coordinates":62},"Point",[63,64],-0.12574,51.50853,{"lat":64,"lon":63},[67,68,69,70,72,73,75,77],{"name":44,"role":45,"phone":46,"phoneExt":36,"email":47},{"name":49,"role":45,"phone":36,"phoneExt":36,"email":50},{"name":39,"role":41,"phone":36,"phoneExt":36,"email":36},{"name":44,"role":71,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"name":49,"role":71,"phone":36,"phoneExt":36,"email":36},{"name":74,"role":71,"phone":36,"phoneExt":36,"email":36},"Oliver Howes, Professor",{"name":76,"role":71,"phone":36,"phoneExt":36,"email":36},"Mitul Mehta, Professor",{"name":78,"role":71,"phone":36,"phoneExt":36,"email":36},"David Lythgoe, Senior Research Fellow",{"facility":80,"status":54,"city":55,"state":56,"zip":81,"country":58,"countryCode":59,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Department of Computer Science, Faculty of Engineering Science, University College London","WC1E 6BT",{"type":61,"coordinates":83},[63,64],{"lat":64,"lon":63},[86,89],{"name":87,"role":45,"phone":36,"phoneExt":36,"email":88},"Rick Adams, Professor","rick.adams@ucl.ac.uk",{"name":87,"role":41,"phone":36,"phoneExt":36,"email":36},{"facility":91,"status":54,"city":92,"state":36,"zip":93,"country":58,"countryCode":59,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"School of Psychology, University of birmingham","Birmingham","B15 2TT",{"type":61,"coordinates":95},[96,97],-1.89983,52.48142,{"lat":97,"lon":96},[100,103],{"name":101,"role":45,"phone":36,"phoneExt":36,"email":102},"Rachel Upthegrove, Professor","r.upthegrove@bham.ac.uk",{"name":101,"role":41,"phone":36,"phoneExt":36,"email":36},{"type":41,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Katherine Beck","Clinical Lecturer and Consultant Psychiatrist",[108,110],{"name":109,"class":6},"Rosetrees Trust",{"name":53,"class":6},"100589699","investigating-the-effect-of-diroximel-fumarate-on-glutathione-in-schizophrenia-100589699",false,"NCT06957808","Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia","FORTUNE","Inclusion Criteria:\n\n* 18 -65 years, diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)\n* Stable antipsychotic dose (no change for 1 month)\n* Currently stable with no evidence of relapse within the last 2 months prior to study enrolment\n* Minimum of 60 on the Positive and Negative Syndrome Scale (PANSS)\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* 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\n* 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)\n* 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\u002FL LLN for Viapath King's College London), suspected or confirmed progressive multifocal leukoencephalopathy (PML), presence of risk factors for PML (previous and\u002For 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)\n* Substance dependence\u002Fabuse other than to cigarettes\n* Current high suicide risk\n* Participation in a clinical study of unlicensed medicines within the previous 30 days\n* Presence\u002Fhistory 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)\n* Allergies to any of DRFs ingredients\n* Taking part in a research study involving an unlicensed medicine within the last 30 days","ALL","18 Years","65 Years",{"count":122,"type":123},30,"ESTIMATED","INTERVENTIONAL",[126],"NA","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\u002F100 (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\u002Fdummy 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\u002Fdummy 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.",[129],"Schizophrenia Disorders",[131,132,133,134,135,136,137],"psychosis","schizophrenia","inflammation","diroximel fumarate","neuroimaging","antioxidant","glutathione","2026-02-11",{"date":140,"type":141},"2026-02-13","ACTUAL",{"date":143,"type":141},"2025-01-10",{"date":145,"type":123},"2027-01-20",{"name":5,"class":6},3]