Psychoses
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-20
Sponsors
Fakultní nemocnice Brno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Dg. F20, F25 according to ICD-10 , treated with olanzapine or initiated treatment by olanzapine 2. Age 18-60 years 3. Signing the informed consent 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Involuntary hospitalization 2. Sui juris restriction or divestiture 3. Olanzapine or caffeine contraindication 4. Pregnancy or breastfeeding 5. Disagreement with the required contraception method(s) 6. Prior participation in any other trial involving investigational medication or medical devices within 14 days prior to the enrolment and during this trial; 7. Other serious medical or psychiatric illness that is not adequately controlled and, in the Investigator’s opinion, would not permit the subject to be managed according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the proposed project is to evaluate proportions of polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC 3, 4 and cytosine methylation of 5HT2A gene and metabolic phenotype of CYP1A2 in the population of patients with SCZ and schizoaffective disorders.;Secondary Objective: The secondary goal of the study is to evaluate which inherited or acquired genetic and epigenetic dispositions may affect the response to olanzapin treatment of psychoses associated with F20 – schizophrenia, and F25 – schizoaffective disorders.;Primary end point(s): The endpoints associated with patient’s genetic and epigenetic background: 1. frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC 3, 4 2. cytosine methylation of 5HT2A 3. metabolic phenotype of CYP1A2 The endpoints associated with olanzapine efficacy: 1. Response rate: The therapeutic response is defined as 20% reduction in PANSS score (see Chapter 7.3) on day 14 and 30% reduction in PANSS score on day 28 compared to the initial score. 2. Remission rate: Remission is defined in compliance with the “Remission in Schizophrenia Working Group” as reduction of the severity of symptoms evaluated in items P1, P2, P3, G5, G9, N1, N4, N6 of PANSS scale to = 3 degree; with respect to the hospitalization period, although the recommended time factor (6 months) will not be included in the evaluation. 3. Time to reach the therapeutic effect. 4. Number of "drop-outs" (olanzapine treatment cessation) and their reasons. ;Timepoint(s) of evaluation of this end point: End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The endpoints associated with olanzapine tolerability: 1. Side effects assessment: UKU scale 2. Treatment of the adverse effects of olazapine – medication, doses, treatment duration, changes in olanzapin administration.;Timepoint(s) of evaluation of this end point: End of the study | — |
Countries
Czech Republic
Contacts
Public ContactFarmakologický ústav
Masarykova univerzita - Lékarská fakulta
Outcome results
None listed