E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |