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Trial record 38 of 452 for:    QUETIAPINE

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

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

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE November 25, 2008
Last Update Posted Date April 29, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00797927 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
changes from baseline in PANSS [ Time Frame: baseline and 28th day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Schizophrenia
Official Title  ICMJE Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Patients With Schizophrenia
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: quetiapine
    quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days
    Other Name: seroquel
  • Other: no intervention
    keep the original conventional antipsychotic agent for 28 days
    Other Name: typical antipsychotics
Study Arms  ICMJE
  • Experimental: 1. quetiapine
    quetiapine would replace the original conventional antipsychotic agent
    Intervention: Drug: quetiapine
  • No Intervention: 2. conventional antipsychotics
    Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00797927
Other Study ID Numbers  ICMJE 200702010M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tzung-Jeng Hwang, attending psychiatrist, National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE National Science Council, Taiwan
Investigators  ICMJE
Principal Investigator: Tzung-Jeng Hwang, MD Department of Psychiatry, National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP