CTIS2023-504181-38-00进行中(未招募)1 期
Assessment of microglial activation in patients with schizophrenia stratified for C4 complement by PET using [18F]DPA-714 - C21-21
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64(—)
- 性别
- All
入选标准
- •Male or Female, aged from 18 to 55, patients with schizophrenia diagnostic according to DSM-5 and presenting HLA 8.1 AH haplotype (8.1 AH+) or presenting no HLA 8.1 AH haplotype ( (8.1 AH-), Male or Female healthy controls aged from 18 to 55 matched regarding age, sex, HLA/C4 according to patients (8.1 AH+ or 8.1 AH-)., Having Efficient Contraception for women of reproductive age ( contraception will be considered effective from the moment the patient declares the use of an oral contraceptive, the presence of an IUD other than copper ones, a diaphragm or a contraceptive implant, or the completion of a tubal ligation or sterilization by Essure process), Be able to understand research objectives and procedures, Be affiliated with or be a beneficiary of a social security scheme, Genetic criterion: TSPO genotype allowing tracer fixation (90% of subjects), Have signed a free and informed consent
排除标准
- •Progressive chronic inflammatory disease (rheumatic, digestive, autoimmune), Adult subject to legal protection (guardianship of a tutor, or safeguard of justice), For healthy volunteers only : Pathology or history of Axis 1 psychiatric pathology investigated by the validated French version of the MINI (Mini International Neuropsychiatric Interview) questionnaire, Known hypersensitivity to radiopharmaceutical ([18F]DPA-714 or one of the excipients), History of severe renal or liver failure, Contraindication to MRI : pacemaker or neurosensory pacemaker or implantable defibrillator; clip on an aneurysm or clip on a vascular malformation of the brain; ferromagnetic intraocular or cerebral foreign body; prosthesis or ferro-metallic objects or fragments mobilizable magnetic; cochlear implants; peripheral stimulator; ventriculoperitoneal neurosurgical bypass valves; permanent eye or lip makeup. Automatic injection device type insulin pump, blood glucose sensor, Claustrophobia, Current pregnancy, breastfeeding, Person refusing to be informed of a significant health finding discovered in the research, Participation in research or management of a pathology with ionizing radiation exposure as part of a nuclear medicine examination (PET, SPECT, NM) in the year prior to or during the exclusion period of another research, Person deprived of liberty by administrative or judicial decision
研究者
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