Quetiapine and the Dopaminergic Epigenetic Control

NCT00370500 | Completed Phase 4

• 2 other identifiers: D1449L00029EudraCT-Nr: 2005-006151-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Dopamine transporter gene; DNA methylation; Epigenetics

Outcome Measures

Primary Outcomes (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).

  6 month

Study Arms (1)

A

EXPERIMENTAL

There is only one arm in this study. All probands receive quetiapine.

Drug: Quetiapine fumarate

Interventions

Quetiapine fumarate DRUG

Dosage and frequency are judged by the study physician. The dosage must not excess 800mg/d.

Also known as: Seroquel(R)

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• AstraZeneca: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stefan Bleich, MD

  University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: August 31, 2006
• Study Start: April 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)