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

27. april 2009 opdateret af: National Taiwan University Hospital

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taipei, Taiwan, 100
        • Department of Psychiatry, National Taiwan University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1. quetiapine
quetiapine would replace the original conventional antipsychotic agent
quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days
Andre navne:
  • seroquel
Ingen indgriben: 2. conventional antipsychotics
keep the original conventional antipsychotic agent for 28 days
Andre navne:
  • typical antipsychotics

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The change from baseline in neurochemical peak area ratios (NAA/CRE, NAA/CHO, CHO/CRE) at the end of study
Tidsramme: baseline and 28 th day
baseline and 28 th day

Sekundære resultatmål

Resultatmål
Tidsramme
changes from baseline in PANSS
Tidsramme: baseline and 28th day
baseline and 28th day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Tzung-Jeng Hwang, MD, Department of Psychiatry, National Taiwan University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2007

Primær færdiggørelse (Faktiske)

1. marts 2009

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

24. november 2008

Først indsendt, der opfyldte QC-kriterier

24. november 2008

Først opslået (Skøn)

25. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. april 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2009

Sidst verificeret

1. april 2009

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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