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New treatment option for Schizophrenia Disorders
Official title Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia
ClinicalTrials.gov ID: NCT06957808
What this study is testing
What is Diroximel fumarate (DRF)?
Diroximel fumarate (DRF) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for schizophrenia disorders.
Also referred to as Vumerity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 1/100 (1%) of people.
- Time commitment: about 2 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- History of significant co-morbid medical or neurological disorder including but not limited to HIV, malignancies, Systemic Lupus Erythematosus...
- Current use of medication that is known to interact with DRF, live vaccines given within the period of DRF treatment, nephrotoxic medication...
- Contraindications to DRF (pregnancy, women of childbearing potential not currently using effective contraception (combined pill (oestrogen \&...
- Substance dependence/abuse other than to cigarettes
- Current high suicide risk
- Participation in a clinical study of unlicensed medicines within the previous 30 days
See the full eligibility 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
- 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...
- Contraindications to DRF (pregnancy, women of childbearing potential not currently using effective contraception (combined pill (oestrogen \& progesterone), progesterone -only with inhibition of ovulation, intrauterine...
- 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...
- Allergies to any of DRFs ingredients
- Taking part in a research study involving an unlicensed medicine within the last 30 days
The study team makes the final eligibility decision.
Where it's taking place
- London, Greater London, United Kingdom
- Birmingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Greater London, United Kingdom; Birmingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.