Patients suffering from schizophrenia (ICD10: F20.x) Healthy controls MedDRA version: 8.1 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders
Conditions
Interventions
Trade Name: Seroquel
Product Name: Seroquel
Pharmaceutical Form: Film-coated tablet
CAS Number: 111974722
Other descriptive name: QUETIAPINE FUMARATE
Concentration unit: mg milligram(s)
Concentration
Sponsors
University of Erlangen-Nuremberg
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. A diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) 3. Able to understand and comply with the requirements of the study 4. Age: 18 – 65 years 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any DSM-IV Axis I disorder not defined in the inclusion criteria 2. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 3. Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator 4. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir 5. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 6. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before inclusion 7. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 8. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 9. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 10. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator 11. Involvement in the planning and conduct of the study 12. Previous enrolment in the present study. 13. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 14. Actual treatment with clozapine or clozapine treatment during the previous three month. Other antipsychotic drugs will be allowed, if intake can be terminated during the two day wash out period. 15. Previous history of major head injuries or neurological disorders 16. Intake of homocysteine lowering vitamins (folate, B12, B6) 17. Renal failure 18. Intake of nutritional derivatives which influence epigenetic patterns (butyrate from milk products, tea polyphenol or epigallo-catechin-3-gallate which inhibits DNMT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dynamics of the DNA methylation of the DAT gene due to treatment with quetiapine in schizophrenic patients.;Secondary Objective: To determine whether quetiapine influences the global and gene-specific epigenetic control of genes belonging to the dopaminergic or serotonergic pathways. To analyse, whether treatment with quetiapine interferes with possible differences between patients and controls. To further determine, if changes in DNA methylation correlate with efficacy, safety and tolerability of quetiapine treatment, measured using CGI-S, PANSS and AIMS (safety).;Primary end point(s): Primary variable is the amount of methylated vs. unmethylated promoter specific DNA in the DAT gene of patients before and after treatment with quetiapine (within group comparison). | — |
Countries
Germany
Outcome results
None listed