European Long-acting Antipsychotics in Schizofrenia Trial EULAST - EULAST

EGRIS0 个研究点目标入组 520 人开始时间: 2014年11月19日最近更新: 2021年10月8日

试验速览

暂无简介。

•1.Diagnosis of schizophrenia as defined by DSM-IV-R as determined by the M.I.N.I.plus
•2.Age 18 or older.
•3.The first psychosis occurred at least 6 months and no more than 7 years ago.
•4.If patients are using an antipsychotic drug, a medication switch is currently under consideration.
•5.Capable of providing written informed consent
•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 520
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Intolerance / hypersensitivity to both* of the drugs (including active substances, metabolites and excipients) in this study including oral paliperidone and aripiprazole and/ or hypersensitivity to risperidone.
•2.Pregnancy or lactation.
•3.Patients who are currently using clozapine.
•4.Patients who do not fully comprehend the purpose or are not competent to make a rational decision whether or not to participate.
•5.Patients with a documented history of intoleranse to both* of the study medications and/ or a documented history of non-response to a treatment with both* study drugs of at least 6 weeks within the registered dose range.
•6.Forensic patients.
•7. Patients who have been treated with an investigational drug within 30 days prior to screening.
•8. Simultaneous participation in another intervention study
•(neither medication nor psychosocial intervention).
•* If intoleranse/ hypersensitivity or non-response in the past to one of
•the compounds is documented, the patient can still participate; however, randomization will take place by blocking that specific compound.

发起方

EGRIS