- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00205608
Microglia Activation in Schizophrenia
Microglia Activation in Schizophrenia: a Pilot Study
연구 개요
상세 설명
Schizophrenia is a complex and chronic disease that affects different aspects of cognition and behaviour, including attention, perception, thought processes, emotion and volition. Schizophrenia is a brain disease particularly involving decrement in gray matter as has been supported by findings from many imaging studies. The pathophysiology of these gray matter changes has not been clarified. Microglia activation is the consequence of virtually all conditions associated with neuronal injury. When activated following neuronal damage, microglia show a marked increase in the expression of peripheral type benzodiazepine binding sites which are particularly abundant on cells of the mononuclear macrophage.
(R)-PK11195 [1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl]-3 isoquinolinecarboxamide) is a highly selective ligand for the peripheral benzodiazepine binding site. (R)-PK11195, labelled with the positron emitter carbon-11, can be used to monitor the peripheral type benzodiazepine receptors using Positron Emission Tomography (PET). At the Vrije Universiteit Medical Centre (R)-[11C]PK11195 is used for studying microglia activation in-vivo in patients with traumatic brain damage, minimal cognitive impairment and Alzheimer disease.
The objective of this study is to determine whether and to what extent microglia activation occurs in schizophrenia. Ten patients with schizophrenia will be recruited and 10 controls, matched for age and gender. This is an open study. The study consists of one PET scan, which will be performed at the Clinical PET Centre of the Vrije Universiteit Medical Centre. All subjects will also get a MRI scan, which will be performed at the department of Radiology, University Medical Centre Utrecht.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드, 1081 HV
- VU University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Schizophrenia according to DSM-IV criteria confirmed by a diagnostic interview (CASH, only for patients) within the first 5 years after initial diagnosis
- Male and Females
- Good physical or mental (controls) Health which will be evaluated with medical history, a physical examination and screening laboratory tests (see appendix 1).
- Age between 18 and 40 years (10 patients and 10 controls)
- Mini Mental State score >27 .
- Written informed consent of the subject.
- Hb must be >8 mmol \ litre at the time of the screening.
Exclusion Criteria:
- Previous neurotrauma with loss of consciousness
- Any clinical significant abnormality of any clinical laboratory test, including drug screening.
- Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug.
any other major current psychiatric diagnosis on axis-1 of DSM-IV (patients)
- History of psychiatric or neurological illness (controls)
- History of psychiatric or neurological illness in first-degree relatives (controls)
- History of alcohol and/or drug abuse (DSM-IV criteria)
- Blood donation within 3 months before the scan day
- Claustrophobia
- Metal objects in or around the body (braces, pacemaker, metal fragments); Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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[11C]-(R)-Pk11195 binding
기간: within 5 years of start symptoms
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microglia activation in schizophrenia
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within 5 years of start symptoms
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Positron Emission Tomography에 대한 임상 시험
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University Hospital ErlangenDepartment of Medicine 1 University Hospital Erlangen, Prof. Dr. Maximilian J. Waldner완전한
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University Hospital, Ghent종료됨
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin완전한
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San Giovanni Addolorata HospitalCentro per la Lotta Contro l'Infarto - Fondazione Onlus알려지지 않은
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Centre Hospitalier Universitaire de Saint EtienneNational Research Agency, France빼는암종 | 각화증 | 생검 | 혼합종양, 악성 | 절제술