protocolSection identificationModule nctId: NCT06270108, orgStudyIdInfo id: 22/SS/0040, secondaryIdInfos id: 299382, type: OTHER, domain: Integrated Research Application System, briefTitle: The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia, acronym: RESTORE, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: South London and Maudsley NHS Foundation Trust, descriptionModule briefSummary: The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology.The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia., conditionsModule conditions: Treatment-resistant Schizophrenia, conditions: Treatment-responsive Schizophrenia, conditions: Healthy Controls, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a basic science study the purpose of which is to to explore the responsivity of glutamate in treatment-resistant schizophrenia to a given challenge (riluzole)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Riluzole, outcomesModule primaryOutcomes measure: Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration, secondaryOutcomes measure: Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging), secondaryOutcomes measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging), secondaryOutcomes measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Psychiatry, Psychology and Neuroscience, status: RECRUITING, city: London, zip: SE5 8AB, country: United Kingdom, contacts name: James Scott, role: CONTACT, phone: +44 207 848 0002, email: james.1.scott@kcl.ac.uk, contacts name: Guy Gitlin-Leigh, role: CONTACT, email: guy.1.gitlin-leigh@kcl.ac.uk, contacts name: Oliver D Howes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False