Effect of Diroximel Fumarate on Brain Antioxidant Levels in Schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transition Support for First-Episode Psychosis

  A team-based program helps people experiencing their first psychotic episode move from hospital to outpatient care to see if they stay engaged and feel better.

  Recruiting University of Chicago · Chicago, Illinois and 1 other locations · NCT07713849

• SEEG-guided DBS for Schizophrenia

  This study tests whether SEEG-guided deep brain stimulation can help people with treatment-resistant schizophrenia see if symptoms improve.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07671261

• Using an epigenetic drug to boost virtual reality cognitive training for middle-aged and older adults with depression or bipolar disorder

  This trial will test whether daily sodium butyrate combined with three weeks of virtual reality cognitive training improves thinking skills in symptomatically stable adults aged 40–75 with depression or bipolar disorder.

  Recruiting Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Frederiksberg, Capital Region of Denmark · NCT07404085

• Medical and psychiatric profiling of adults admitted to general adult psychiatry wards

  This project will collect questionnaires, rating scales, and case-note information from adults admitted to general adult psychiatry wards to see what their physical and mental health profiles look like.

  Recruiting University of Edinburgh · Livingston, West Lothian · NCT07398365

• iTEST: a blended mobile program to improve introspective accuracy (accurate self-judgment of abilities)

  This trial tests whether iTEST — daily mobile cognitive training plus coaching that focuses on accurate self-judgment — helps adults with schizophrenia-spectrum or other psychotic disorders improve community functioning.

  Recruiting at 3 sites University of California, San Diego · San Diego, California and 2 other locations · NCT07098169

• VR avatar therapy for psychosis: linking thinking, self-awareness, and social cognition

  This project will test whether cognitive, metacognitive, and social-cognition factors relate to how well VR-based avatar therapy helps people with schizophrenia who have persistent auditory hallucinations.

  Recruiting Fundació Sant Joan de Déu · Barcelona, Catalonia · NCT07091344

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.