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Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Schizophrenia

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: NCT00797927
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : April 29, 2009
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:
we aim to examine whether a representative atypical antipsychotic, quetiapine, has different effects from conventional antipsychotics on the magnetic resonance spectroscopy (MRS) markers in schizophrenia patients.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: quetiapine Other: no intervention Phase 4

Detailed Description:

The impact of medications on MRS changes in brain of schizophrenia patients have rarely been studied through a well-controlled study. Most of the MRS studies in schizophrenia patients are cross-sectional and uncontrolled and devoid of any comparison between effects of different drugs. To date, only limited research has explored this issue and the results are conflicting. These conflicting results may be related to small sample size, different patient population and design in these studies. Thus, further studies are warranted. Besides, with the advent of new generation atypical antipsychotics, it will be important to know whether atypical antipsychotics exert different effects on neurons from conventional antipsychotics. If neuronal activity can be improved by atypical antipsychotics, the findings will have great clinical implications.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Patients With Schizophrenia
Study Start Date : January 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: 1. quetiapine
quetiapine would replace the original conventional antipsychotic agent
Drug: quetiapine
quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days
Other Name: seroquel

No Intervention: 2. conventional antipsychotics Other: no intervention
keep the original conventional antipsychotic agent for 28 days
Other Name: typical antipsychotics

Primary Outcome Measures :
  1. The change from baseline in neurochemical peak area ratios (NAA/CRE, NAA/CHO, CHO/CRE) at the end of study [ Time Frame: baseline and 28 th day ]

Secondary Outcome Measures :
  1. changes from baseline in PANSS [ Time Frame: baseline and 28th day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Provision of written informed consent
  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

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Any DSM-IV Axis I disorder not defined in the inclusion criteria
  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

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): NCT00797927

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Department of Psychiatry, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
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Principal Investigator: Tzung-Jeng Hwang, MD Department of Psychiatry, National Taiwan University Hospital
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Responsible Party: Tzung-Jeng Hwang, attending psychiatrist, National Taiwan University Hospital Identifier: NCT00797927    
Other Study ID Numbers: 200702010M
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Keywords provided by National Taiwan University Hospital:
conventional antipsychotics
magnetic resonance spectroscopy
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Antidepressive Agents
Psychotropic Drugs
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs