Safety and efficacy of olanzapine treatment in psychosis: Effect of genetic and epigenetic factors – covariates of treatment response

Phase 1

Recruiting

Conditions: Psychoses
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873
MedDRA version: 21.1Level: LLTClassification code: 10039613Term: Schizo-affective type schizophrenia Class: 10037175

Registration Number: CTIS2022-502902-33-00

Lead Sponsor: Masarykova Univerzita

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Age 18-60 years, Dg. F20 (schizophrenia) or F25 (schizoaffective disorders) according to ICD-10, Established treatment with olanzapine, or planned initiation of olanzapine treatment, Expressed the informed consent and will to co-operate, Women of childbearing potential can be included only if they are using at least an acceptable effective contraceptive measure (Chapter 8.10)

Exclusion Criteria

Sui juris restriction or divestiture, Olanzapine or caffeine contraindication, Pregnancy, or planning to conceive, breastfeeding, Prior participation in any other trial involving investigational medication or medical devices within 14 days prior to the enrolment and during this trial, 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
Main Objective: The primary aim is to evaluate proportions (frequency) of gene polymorphisms in CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4 genes in the study population of patients with schizophrenia.;Secondary Objective: The secondary aims are the evaluation of the effect of covariates (gene polymorphisms, CYP1A2 phenotype, cytosine methylation of 5HT2A receptor gene, levels of olanzapine and desmethylolanzapine in serum, smoking habits and co-medication) on the efficacy and safety (tolerability) of olanzapine treatment in the study population.;Primary end point(s): Frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4

Secondary Outcome Measures