FORTUNE
Overview
Have you experienced psychosis? Help us to better understand psychosis!
The study
- We want to know if a drug called Diroximel Fumarate can increase levels of a brain chemical called glutathione, thought
to be altered in people who experience psychosis. - Diroximel Fumarate is already being used to treat multiple sclerosis.
- We will use MRI and EEG to see the effect of Diroximel Fumarate in the brain.
What would I need to do?
- 4 visits to our research facility and 2 phone appointments.
- An MRI (brain) scan & EEG (non-invasive brain cap that measures brain activity).
- Taking Diroximel Fumarate in addition to your current medication for 2 weeks, then you either continue taking DRF for
another 2 weeks or a dummy pill or placebo (study lasts 4 weeks in total).
Who is doing this research and where?
- The study is performed by researchers who work at the Institute of Psychiatry, Psychology and Neuroscience, King’s
College London and South London and Maudsley NHS Foundation Trust. - The study will take place at the Centre for Neuroimaging Sciences and Institute of Psychiatry, Psychology and Neuroscience (De Crespigny Park), and the Clinical Research Facility, King’s College Hospital.
How would I be compensated?
- Reimbursement of travel expenses.
- Compensation for your time (vouchers).
- Knowing that you are supporting research for future treatment for people with psychosis.
Are you interested in taking part in this study?
Planned end date
31 Mar 2028 00:00Conditions
SchizophreniaInclusion 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
•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 with recognized effect on glutamatergic signalling (e.g. lamotrigine, lithium, carbamazepine, opiates, and psychostimulants) OR 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