Simvastatin addition to improve symptoms, cognition and metabolic syndrome in patients with recent-onset schizophrenia. - Simvastatin in patients with recent-onset schizophrenia.

niversity Medical Center Utrecht0 个研究点目标入组 250 人开始时间: 2013年6月5日最近更新: 2020年7月6日

适应症

试验速览

暂无简介。

•A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or schizoaffective disorder) or 298.9 (psychosis NOS), no longer than 3 years ago.
•Age between 18 and 50 years.
•Written informed consent is obtained.
•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 250
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 amino transferase (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, rhabdomyolyse 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)

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