Esquizofrenia crónica controlada. (10 pacientes con el genotipo val/val y 10 pacientes con el genotipo met/met) MedDRA version: 16.1 Level: LLT Classification code 10009134 Term: Chronic schizophrenia System Organ Class: 100000004873
Conditions
Interventions
Trade Name: TASMAR 100 mg comprimidos recubiertos con película
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TOLCAPONA
Other descriptive name: TOLCAPONE
Concentration unit: mg milligram
Sponsors
Clínica Universidad de Navarra/Universidad de Navarra
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to give informed consent and express the wish to fulfill all the requirements of the protocol during the study period. 2. The patient must be capable of fulfillment of all the requirements of the clinical trial, at the investigator?s discretion. 3. Age between 18 and 65 years. 4. Patients diagnosed with schizophrenia according toDSM-5. Only chronic patients will be recruited, and they must be clinically compensated in order to consent to participate. The determination of clinical compensation will be conducted according with these criteria: i) outpatients, with absence of hospitalization due to acute psychiatric decompensation in the previous year, and ii) maintained GAF score equal or higher than 60 during the previous month. The recruitment process will include a clinical interview to verify the diagnosis. 5. Caucasic ethnicity. 6. Negative pregnancy test for women of childbearing age. 7. Due to the high prevalence of tobacco smoking habit among patients with schizophrenia, only patients who smoke 15-30 cigarettes per day will be recruited. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe infections or diseases or hepatic failure (or increased liver enzymes), renal failure or bone marrow failure that advise against participation in the study at the investigator?s discretion. 2. Liver alterations (elevated liver enzymes above normal values) that advise against the patient participation in the study, at the investigator´s discretion 3. Positive pregnancy test, or breastfeeding women. 4. Carriers of pacemaker or any kind of metallic prosthesis incompatible with magnetic resonance imaging. 5. History of hypersensitivity to Tasmar® (Tolcapona) or to any of its components. 6. Active (in the last 12 mounths) substance abuse, or other disease that causes psychiatric symptoms. 7. Cardiovascular disease and electrocardiogram alterations. 8. Patients receiving treatment with monoamine oxidase inhibitors during the study or up to 15 days prior to the beginning of the study. 9. Patients receiving treatment with a COMT inhibitor. 10. Participation in another clinical trial in the previous 30 days. 11. Other circumstances which involve Tasmar® (Tolcapona) contraindications: history of Neuroleptic Malignant Syndrome and/or non-traumatic Rhabdomyolysis or Hypertermia. Severe dyskinesia. Phaeochromocytoma. Hereditary galactose intolerance. Lapp lactase deficiency or glucose or galactose malabsortion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the efficacy of tolcapone, as the first non-stimulant drug to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.;Secondary Objective: 1. To study the performance of patients with schizophrenia in cognitive tasks dependent on prefrontal cortex, which require the functions of attention and context processing. 2. To determine dysfunctional brain areas in patients with schizophrenia when conducting such cognitive tasks. 3. To establish associations between the genotypes of the COMT enzyme polymorphism rs4680 and the cognitive performance in the administered tests, searching for genetic profiles that may be prognostic markers regarding cognitive performance and response to pharmacological treatment for schizophrenia.;Primary end point(s): The primary end points are the performance in the cognitive test DPX (Modified MATRICS battery: number of errors and reaction times) and the elicited brain activation during functional neuroimaging (relative degree of activation of different brain regions). The DPX test has been selected for this study because of its capacity to discriminate the cognitive changes in clinical trials of cognitive enhancers in schizophrenia. The primary end point yielded by functional neuroimaging is the BOLD response, which reflects the relative degree of activation of different brain regions. The performance in the cognitive test will be measured in function of the number of errors and reaction times.;Timepoint(s) of evaluation of this end point: The test during the functional neuroimaging will be conducted on Day 1 in the morning, prior to the first dose of Tolcapone, and on Day 8, after the morning dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end points are the scores on the clinical scales (PANSS, BPRS, CGI and GAF) and the cognitive neuropsychological battery (MATRICS modified).;Timepoint(s) of evaluation of this end point: The test during the functional neuroimaging will be conducted on Day 1 in the morning, prior to the first dose of Tolcapone, and on Day 8, after the morning dose. The clinical scales (PANSS, BPRS, CGI and GAF) will be conducted on Day 0 and on Day 8, after the neuroimaging. | — |
Countries
Spain
Contacts
Public ContactUCICEC
Clínica Universidad de Navarra
Outcome results
None listed