Status:
RECRUITING
Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia
Lead Sponsor:
King's College London
Collaborating Sponsors:
Rosetrees Trust
Conditions:
Schizophrenia Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
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 1/10...
Detailed Description
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: Participa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06957808
Start Date
January 10 2025
End Date
June 1 2026
Last Update
May 5 2025
Active Locations (3)
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1
South London and Maudsley NHS Foundation Trust
London, Greater London, United Kingdom, SE58AZ
2
Department of Computer Science, Faculty of Engineering Science, University College London
London, Greater London, United Kingdom, WC1E 6BT
3
School of Psychology, University of birmingham
Birmingham, United Kingdom, B15 2TT