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Trial record 58 of 450 for:    QUETIAPINE

Quetiapine and the Dopaminergic Epigenetic Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370500
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : July 11, 2008
Information provided by:
University of Erlangen-Nürnberg Medical School

Brief Summary:


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. whether differences in the methylation pattern of the promoters of dopaminergic genes exist between schizophrenic patients and healthy controls and
  2. whether treatment with the second generation antipsychotic quetiapine leads to changes in the methylation pattern of those genes in patients suffering from schizophrenia.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: A
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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

For inclusion in the study subjects must fulfil all of the following 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

Exclusion criteria:

Any of the following is regarded as a criterion for exclusion from the study:

  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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00370500

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Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg
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Principal Investigator: Stefan Bleich, MD University of Erlangen-Nürnberg

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Responsible Party: Stefan Bleich, University of Erlangen-Nürnberg Identifier: NCT00370500     History of Changes
Other Study ID Numbers: D1449L00029
EudraCT-Nr: 2005-006151-20
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: July 11, 2008
Last Verified: July 2008
Keywords provided by University of Erlangen-Nürnberg Medical School:
Dopamine transporter gene
DNA methylation
Additional relevant MeSH terms:
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Quetiapine Fumarate
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Dopamine Agonists
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents