EUCTR2010-022181-28-CZ进行中（未招募）不适用
A 6-month, randomised, double-blind, parallel-group, risperidone-controlled, fixed-dose study evaluating the safety and efficacy of zicronapine in patients with schizophrenia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •- The patient meets the DSM-IV-TR criteria for schizophrenia (codes 295.10, 295.20, 295.30, 295.90)
- •- The patient is a man or woman, =18 and =65 years old
- •- The patient has a PANSS total score =60 and =100 at screening and baseline
- •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 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- The patient has a current Axis I psychiatric disorder other than schizophrenia as defined in the DSM-IV-TR
- •- The patient has a current diagnosis or a history of substance dependence (except nicotine) or substance abuse (except cannabis) according to the DSM-IV-TR? criteria =6 months prior to screening
- •- The patient is at significant risk of harming himself/herself or others according to the investigator’s judgement (assisted by the assessment of suicidal ideation and behaviour using the C-SSRS)
- •- The patient is resistant to antipsychotic treatment according to the investigator’s judgement or has been treated with clozapine = 3 months prior to screening
- •- The patient has experienced an acute exacerbation requiring hospitalisation = 3 months prior to screening or between screening and baseline
- •- The patient has been treated with risperidone or paliperidone =6 months prior to screening
- •- The patient has been treated with an adequate course of risperidone or paliperidone and failed to respond or has shown intolerance to the drug according to the investigator`s judgement
研究者
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