Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Schizophrenia
NCT ID: NCT00797927
Last Updated: 2009-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2007-01-31
2009-04-30
Brief Summary
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Detailed Description
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Fifteen patients in the experimental group will receive MRS examinations (including bilateral frontal and temporal area) in two phases: baseline (when they are on a conventional antipsychotic) and 4 weeks after shifting from that conventional antipsychotic to quetiapine. Another 15 schizophrenia patients receiving conventional antipsychotics will serve as the control group. The control group will receive the MRS examinations twice (baseline and 4 weeks later) without change of medications. In each phase, every patient will also receive the Positive and Negative Syndrome Scale (PANSS) assessment. The changes of the MRS markers will be analyzed and compared, both within and between the 2 groups, and their correlations with the PANSS scores will be explored.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. quetiapine
quetiapine would replace the original conventional antipsychotic agent
quetiapine
quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days
2. conventional antipsychotics
no intervention
keep the original conventional antipsychotic agent for 28 days
Interventions
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quetiapine
quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days
no intervention
keep the original conventional antipsychotic agent for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A diagnosis of schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
3. Females or males aged \> 20 and \< 65 years
4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
5. Able to understand and comply with the requirements of the study
6. Undergoing treatment with a conventional antipsychotic drug and is clinically stable
3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
4. Known intolerance or lack of response to quetiapine, as judged by the investigator
5. 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
6. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampicin, St. John's Wort, and glucocorticoids
7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment as judged by the investigator
11. Involvement in the planning and conduct of the study
12. Previous enrolment or randomisation of treatment 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. Subjects with metal prosthesis such as cardiac valves etc
15. Severe neurological co-morbidity such as stroke, encephalopathy etc or medical conditions that will compromise on the safety of patients such as acute myocardial infarction, systemic infections etc as judged by the investigator
Exclusion Criteria
20 Years
65 Years
ALL
No
Sponsors
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National Science and Technology Council, Taiwan
OTHER_GOV
National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Hospital
Principal Investigators
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Tzung-Jeng Hwang, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, National Taiwan University Hospital
Locations
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Department of Psychiatry, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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200702010M
Identifier Type: -
Identifier Source: org_study_id