schizophrenia MedDRA version: 16.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Tasmar
Product Name: tolcapone
Pharmaceutical Form: Coated tablet
INN or Proposed INN: TOLCAPONE
CAS Number: 134308-13-7
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
MediPsych SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must meet all the following criteria to be eligible for this study: 1. The patients will be male or female, aged from 18 to 65 years old. 2. The patient is willing and able to provide signed informed consent form. For patients in acute relapse, legal representatives will be required to sign the consent form. 3. The patient will have an official diagnosis of Schizophrenia or Schizoaffective disorder according to the DSM-IV TR criteria and will display the cognitive and negative symptoms of schizophrenia. 4. The patient will be either at relapse of the disorder (Group 1) or at the early stages of the disease and/or stabilised (Group 2) and takes standard antipsychotic medication. 5. If the patient is sexually active, then s/he must satisfy one of the following criteria: a) For Women: They should not be pregnant or be in lactation period. They should be either surgically sterilized or be in postmenopausal period. The patient’ partner should apply an accepted and highly effective contraceptive regimen (a shape which leads to failure rate =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria will be excluded from this study. 1. The patient is hypersensitive to tolcapone. 2. The patient has hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose - galactose malabsorption. 3. The patient suffers from severe physical and neurological active disease and /or present history of Neuroleptic Malignant Syndrome. 4. The patient is suffering from liver dysfunction and / or increased liver enzymes (serum alanine aminotransferase (ALT) and / or aspartamikis aminotransferase (AST) = 1,5 x ULN) 5. The patient suffers from severe renal impairment (creatinine clearance <30 ml / min) 6. The patient suffers from epilepsy 7. The patient is suffering from severe dyskinesia and/or from non - traumatic Rhabdomyolysis or Hyperthermia. 8. The patient is suffering from pheochromocytoma. 9. The patient has a previous history of Neuroleptic Malignant Syndrome (NMS). 10. The patient has suffered a myocardial infarction within the last 6 months. 11. The patient receives treatment with non - selective inhibitors of mono - amino - oxidase (MAO) inhibitors (eg phenelzine and tranylcypromine). If the patient is treated with a selective inhibitor of MAO –B, it should not exceed the recommended dose (eg for selegiline < 10mg/day) when co-administered with tolcapone . 12. The patient receives other enzyme inhibitor COMT drugs (e.g. entacapone, clozapine) or other dopaminergic drugs. 13. The patient is being treated with levodopa and benserazide. 14. The patient receives or has received in the past another investigational drug, biologic or device within 4 weeks of the preliminary assessment. 15. The patient receives antipsychotic medication known to exclude D1 receptors with high binding (affinity) such as flupenthixol , fluphenazine , ziprasidone , chlorpromazine , and olanzapine (Ki 4, 6, 30, 35 and 48 respectively). 16. The patient according to the investigator is unable to meet the requirements of the study. 17. The patient has a current or recent history of drug or alcohol or shows reluctance to decrease the consumption of alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main Objective: The main objective of this study is to investigate whether the drug tolcapone - a dopaminergic agent and an inhibitor of the enzyme COMT, now used as adjunctive therapy in Parkinson disease, improves overall the negative and cognitive symptoms of schizophrenia more than antipsychotic treatment alone. As the beneficial effect of tolcapone on prefrontal function depends on the presence of allele Val, the study aims to show that more than 70-80 % of schizophrenia patients may benefit on the prefrontal functioning and consequently exhibit an improvement of negative and cognitive symptoms. ;Secondary Objective: Secondary objective: To examine the relationship between the possible beneficial effect of tolcapone and the COMT genotype of patients. More specifically, to show that tolcapone exhibits a substantial beneficial effect on the negative and cognitive symptoms of schizophrenia in homozygous Val / Val patients ( 30% of the population) , is quite beneficial to heterozygous Val / Met patients ( 50 % of the population) and shows no effectiveness in homozygous Met / Met patients (20 % of the population) . The proposed treatment offers advantages also from a pharmaco - economic point of view , as it could be made to be determined the patient will respond very well, the patient will respond well and the patient will not respond at all. ;Primary end point(s): Examine the efficacy of tolcapone as add-on therapy on the negative and cognitive symptoms of schizophrenia compared to standard antipsychotic treatment alone;Timepoint(s) of evaluation of this end point: every 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Examine the relationship of patients’response to tolcapone according to their COMT genotype.;Timepoint(s) of evaluation of this end point: every 6 months | — |
Countries
Greece
Contacts
Public ContactEvangelia Tsapakis
MediPsych SA
Outcome results
None listed