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Sponsors and Collaborators: |
University of Erlangen-Nürnberg AstraZeneca |
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Information provided by: | University of Erlangen-Nürnberg |
ClinicalTrials.gov Identifier: | NCT00370500 |
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
STUDY DESIGN AND METHODS:
50 male patients and 50 male controls are to be enrolled into the study. Patients will be treated with quetiapine for 3 weeks. Blood samples will be drawn before treatment and after three weeks to measure DNA-methylation status. Clinical characterisation includes PANSS, AIMS, BDI. Healthy probands will not be treated.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Quetiapine fumarate |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Quetiapine and the Dopaminergic Epigenetic Control - a Pilot Study |
Enrollment: | 100 |
Study Start Date: | April 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
There is only one arm in this study. All probands receive quetiapine.
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Drug: Quetiapine fumarate
Dosage and frequency are judged by the study physician. The dosage must not excess 800mg/d.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
For inclusion in the study subjects must fulfil all of the following criteria:
Exclusion criteria:
Any of the following is regarded as a criterion for exclusion from the study:
Germany | |
Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg | |
Erlangen, Germany, 91054 |
Principal Investigator: | Stefan Bleich, MD | University of Erlangen-Nuremberg |
Responsible Party: | University of Erlangen-Nürnberg ( Stefan Bleich ) |
Study ID Numbers: | D1449L00029, EudraCT-Nr: 2005-006151-20 |
Study First Received: | August 30, 2006 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00370500 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Schizophrenia Dopamine transporter gene DNA methylation Epigenetics |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Dopamine Agonists Antipsychotic Agents Schizophrenia |
Quetiapine Dopamine Mental Disorders Psychotic Disorders Dopamine Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Agonists Antipsychotic Agents |
Pharmacologic Actions Schizophrenia Quetiapine Mental Disorders Therapeutic Uses Dopamine Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |