protocolSection identificationModule nctId: NCT06387771, orgStudyIdInfo id: rs4680-tolcapona, briefTitle: Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2014-09-22, primaryCompletionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Clinica Universidad de Navarra, Universidad de Navarra, class: OTHER, descriptionModule briefSummary: Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Tolcapone, outcomesModule primaryOutcomes measure: Efficacy: Change from baseline in cognitive test scores at day 8, primaryOutcomes measure: Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8, secondaryOutcomes measure: Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8, secondaryOutcomes measure: Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8, secondaryOutcomes measure: Change from baseline in plasmatic homocysteine (umol/L), otherOutcomes measure: Patient Reported Outcome: change from baseline in the Profile of Mood States (POMS) scores at day 8, otherOutcomes measure: Patient Reported Outcome: change from baseline in the mood state Visual Analogue Scale (VAS) scores at day 8, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Universidad de Navarra, status: RECRUITING, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Jose Maria Galindo, role: CONTACT, phone: 34 948 255400, phoneExt: 2725, email: ucicec@unav.es, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False