EUCTR2015-001599-23-NL进行中（未招募）1 期
In Vivo Imaging of Neuroinflammation in Simvastatin-Treated Schizophrenic Patients - Neuroinflammation in SIM-treated SCZ patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Control subjects
- •> Age between 18 and 50 years.
- •Schizophrenic patients
- •> Age between 18 and 50 years
- •> A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) or 298.9 (psychosis NOS)
- •> Onset of first psychosis no longer than 3 years ago;
- •> Female patients of childbearing potential need to utilize a proper method of contraception (the pill, vaginal ring, hormonal patch, intrauterine device, cervical cape, condom, contraceptive injection, diaphragm) in case of sexual intercourse during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Control subjects
- •> Women who are pregnant;
- •> Women who intend to get pregnant during the study;
- •> Use or having used psychotropic medication in the past six months;
- •> Alcohol or substance abuse in the past 3 months;
- •> Taking any medication, except oral contraceptives;
- •> Evident somatic/psychiatric co-morbidity;
- •> First-degree relatives with (a history of) schizophrenia or schizophrenia spectrum disorders;
- •> Participation in a scientific research study during the past year involving radiation.
- •> Presence of materials in the body that can be magnetized and cannot be removed.
- •Schizophrenic patients
- •> Fulfilment of criteria of statin prescription; according to the Dutch Heart Foundation (Hartstichting), statin treatment is indicated when the total cholesterol level is > 8 mmol/l (www.hartstichting.nl)
- •> Presence of any of the contra-indications or warnings for the use of simvastatin as reported in the SPC
- •> Chronic use of glucocorticosteroids (temporary use is permitted, if stopped at least 1 month before start of treatment trial)
- •> Chronic use of non-steroidal anti-inflammatory drugs (temporary use is permitted, if stopped at least 1 month before start of treatment trial)
- •> Current use of statins or other lipid-lowering drugs
- •> Pregnancy or breast-feeding
- •> Active liver, kidney or muscle disease as defined by alanine aminotransferase (ALAT), creatinine or creatine kinase (CK) levels more than two times the upper boundary of normal levels
- •> Use of comedication that either inhibits or induces the live enzyme CYP3A4 which is responsible for the degradation of simvastatin. Inhibitors of CYP3A4 include itraconazole, ketoconazole, posaconazole, fluconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, telaprevir, boceprevir, imatinib, ticagrelor, voriconazole; inducers of CYP3A4 include carbamazepine, efavirenz, nevirapin, etravirin (can be washed out before start of trial)
- •> Use of comedication that may increase the risk for myalgia, rhabdomyolysis and myopathy, including colchicine, bosentan, fenobarbital, fenytoin, hypericum, rifabutin, rifampicin, fibrates (e.g. gemfibrozil), fusidic acid, carbamazepine (can be washed out before start of trial)
- •> Use of non-steroidal anti-inflammatory drugs (NSAIDs) one week before the PET scan;
- •> Alcohol or substance abuse in the past 3 months;
- •> Participation in a scientific research study during the past year involving radiation.
研究者
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