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Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

Investigation of Glutathione (GSH) Levels in Schizophrenia Patients Using Investigational Medication in the Anterior Cingulate Cortex (ACC)

Recruiting
18-65 years
All
Phase N/A

This study investigates the effect of an investigational medication on the levels of GSH, a naturally occurring antioxidant, in the ACC region of the brain in patients with schizophrenia. Schizophrenia is a mental health condition characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. The study aims to determine if the investigational medication can increase GSH levels as measured by a specific type of brain scan called 1HMRS.

Participants will initially receive the investigational medication in an open-label format, meaning all will know they are receiving the treatment. After two weeks, they may enter a second phase, where they will be randomly assigned to continue with the investigational medication or switch to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. Throughout the study, participants will undergo blood tests, mental health assessments, EEGs, and MRIs to monitor changes.

  • Who can participate: Adults aged 18 to 65 years with a diagnosis of schizophrenia who are on a stable dose of antipsychotics and have been stable in their mental state for at least two months can participate. They must also have a minimum score of 60 on the Positive and Negative Syndrome Scale and be able to provide informed consent.
  • Study details: Participants will take the investigational medication for two weeks in an open-label phase, followed by a randomized phase where they may continue with the medication or switch to a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will include various assessments such as blood tests, mental health evaluations, EEG, and MRI scans.
Study details
    Schizophrenia Disorders

NCT06957808

King's College London

6 May 2025

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