Quetiapine and the Dopaminergic Epigenetic Control
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|ClinicalTrials.gov Identifier: NCT00370500|
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : July 11, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Quetiapine fumarate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quetiapine and the Dopaminergic Epigenetic Control - a Pilot Study|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370500
|Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg|
|Erlangen, Germany, 91054|
|Principal Investigator:||Stefan Bleich, MD||University of Erlangen-Nürnberg|