Status:
COMPLETED
Quetiapine and the Dopaminergic Epigenetic Control
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
AstraZeneca
Conditions:
Schizophrenia
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief Summary
BACKGROUND: Epigenetic modifications such as DNA-methylation and histone acetylation are known to be involved in the pathophysiology of schizophrenia. Aim of the present study is to investigate 1. w...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- For inclusion in the study subjects must fulfil all of the following criteria:
- Provision of written informed consent
- A diagnosis of schizophrenia by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Able to understand and comply with the requirements of the study
- Age 18 - 65 years
- Exclusion criteria:
- Any of the following is regarded as a criterion for exclusion from the study:
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
- 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
- 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
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before inclusion
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- 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.
- Previous history of major head injuries or neurological disorders
- Intake of homocysteine lowering vitamins (folate, B12, B6)
- Renal failure
- Intake of nutritional derivatives which influence epigenetic patterns (butyrate from milk products, tea polyphenol or epigallo-catechin-3-gallate which inhibits DNMT)
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00370500
Start Date
April 1 2007
End Date
July 1 2008
Last Update
December 14 2020
Active Locations (1)
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1
Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg
Erlangen, Germany, 91054