THE EFFECT OF GENETIC AND EPIGENETIC DISPOZITIONS ON THE EFFICIENCY AND SAFETY OF OLANZAPINE PSYCHOSIS THERAPY
- Conditions
- PsychosesTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2018-002267-25-CZ
- Lead Sponsor
- Fakultní nemocnice Brno
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method