EVALUATION OF THE EFFICACY OF TOLCAPONE AS A GENOTYPE-BASED TARGETED COGNITIVE ENHANCER IN SCHIZOPHRENIA, BASED ON THE POLYMORPHISM RS4680
Key facts
- Where
- Pamplona, SpanyolországSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- Clínica Universidad de navarraPamplona, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clinica Universidad De Navarra
- Trial code
- EU 2024-511433-35-00
- Record updated
- 2024. május 14.
- Original description
To objectify the efficacy of Tolcapone, depending on the genotype for the rs4680 polymorphism of the COMT enzyme gene, to improve cognitive impairment and negative symptoms in patients with long-standing schizophrenia, in the clinical compensation phase.Read full original descriptionShow less
To objectify the efficacy of Tolcapone, depending on the genotype for the rs4680 polymorphism of the COMT enzyme gene, to improve cognitive impairment and negative symptoms in patients with long-standing schizophrenia, in the clinical compensation phase.
Inclusion: Ability to provide informed consent and express your desire to comply with all protocol requirements during the study period; The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial; Age between 18-65 years; Patients diagnosed with schizophrenia according to DSM-5. Only chronic patients will be recruited (disease duration greater than or equal to 5 years) and, in order to obtain informed consent for participation in this study, all patients must be in the clinical compensation phase at the time of recruitment. The determination of clinical compensation will be made according to these criteria: i) patients receiving treatment on an outpatient basis, with no hospitalization due to acute psychiatric decompensation during the previous year, and ii) score on the Global Activity Assessment Scale (GAF) maintained equal to or greater than 60 during the last month. The recruitment process will include a clinical interview to verify the diagnosis; Caucasian origin; In the case of a woman of childbearing age, a negative pregnancy test.
Exclusion: Participation in another clinical trial in the previous 30 days; Patients who, during the study or up to 15 days before starting the study, receive or have received treatment with MAOIs; Patients receiving treatment with a COMT inhibitor; Infections or serious diseases or kidney or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria; History of hypersensitivity to Tasmar® (Tolcapone) or any of its components; Current history (in the last 12 months) of substance abuse or existence of another illness that justifies the appearance of psychiatric symptoms; Cardiovascular disease and clinically relevant ECG alteration; Other situations that imply contraindications for Tasmar® (Tolcapone): History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis or malignant hyperthermia. Severe dyskinesia. Pheochromocytoma. Hereditary lactose or galactase intolerance. Lapp lactase deficiency or glucose or galactose malabsorption; Liver alterations (increase in liver enzymes above normal values) that discourage the patient's participation in the study, according to the investigator's criteria; Positive pregnancy test, or breastfeeding women; Being a wearer of any metal prosthesis or pacemaker incompatible with performing nuclear magnetic resonance.