A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 16
- 主要终点
- Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
研究概览
简要总结
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
详细描述
A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
Trial drugs:
- Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
- Risperidone group: Risperidone tablets+Blonanserin mimetic tablets
Objectives of Study :
To evaluate the efficacy and safety of Blonanserin in treating schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
- •Patients are 18≤age<65 years of age on the day when informed consent is obtained.
- •Subject had a PANSS total score ≥70 and 120≥ at Screening
- •Subject had a score ≥4 on the PANSS at Screening and Baseline.
- •Subjects are willing and able to comply with study protocol including treatment in hospital.
- •Subjects or their legal guardians have signed the written informed consent form.
排除标准
- •The subject was treatment with other Investigate product within 30 days.
- •Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
- •Subject had a history of treatment with clozapine within 28 days.
- •Subject With parkinson disease,etc
研究组 & 干预措施
Blonanserin
Antipsychotics
干预措施: Blonanserin (Drug)
Risperidone
Antipsychotics
干预措施: Risperidone (Drug)
结局指标
主要结局
Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8
时间窗: From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.
Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores\<70 is the normal,but the scores\>120 is more serious.Change=(Week 8 Score - Baseline score)
次要结局
- Mean Change in PANSS Subscale Score at the End of Treatment(week 8)
- Mean Change in PANSS 5-factor Model(Week 8)
- Mean Change in PANSS Symptom Scores(Week 8)
- Mean Change in PANSS Symptom Scores From Baseline at Each Visit(Each Visit)