Quetiapine and the Dopaminergic Epigenetic Control
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
- whether differences in the methylation pattern of the promoters of dopaminergic genes exist between schizophrenic patients and healthy controls and
- whether treatment with the second generation antipsychotic quetiapine leads to changes in the methylation pattern of those genes in patients suffering from schizophrenia.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Quetiapine and the Dopaminergic Epigenetic Control - a Pilot Study|
- 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). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
There is only one arm in this study. All probands receive quetiapine.
Drug: Quetiapine fumarate
Dosage and frequency are judged by the study physician. The dosage must not excess 800mg/d.
Other Name: Seroquel(R)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370500
|Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg|
|Erlangen, Germany, 91054|
|Principal Investigator:||Stefan Bleich, MD||University of Erlangen-Nürnberg|