NCT02137993已完成4 期
A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Change from baseline at 6 week in total PANSS score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years to 65 years
- •Schizophrenia patient with an acute exacerbation
- •Understand the requirement of the study and voluntarily consent to participate in the study
排除标准
- •Patients who have another psychiatric disorders
- •Patients who have unstable medical conditions
- •Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit
- •Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)
- •Patients who have a history of an allergic reaction to olanzapine
- •Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.
- •Patient who take clozapine within 12 weeks before screening visit
研究组 & 干预措施
A-prexa
Experimental
A-prexa 5, 10mg
干预措施: Zyprexa (Drug)
Zyprexa
Active Comparator
Zyprexa 5, 10mg
干预措施: A-prexa (Drug)
结局指标
主要结局
Change from baseline at 6 week in total PANSS score
时间窗: 6 week
次要结局
- Change from baseline at 1, 2, 4 and 6 week in total PANSS score.(6 week)
- Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week(6 week)
- Change from baseline at 6 week in total CGI-S score(6 week)
- Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'(6 week)
研究者
相似试验
已完成
3 期
Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.SchizophreniaNCT00380224Wyeth is now a wholly owned subsidiary of Pfizer120
已完成
3 期
Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute SchizophreniaSchizophreniaNCT00712686Otsuka Pharmaceutical Development & Commercialization, Inc.690
已完成
4 期
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized PatientsSchizophreniaNCT00634348Pfizer's Upjohn has merged with Mylan to form Viatris Inc.256
已完成
4 期
Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 KilogramsNon-Hodgkin's LymphomaNCT01164475Genzyme, a Sanofi Company61
已完成
3 期
Brexpiprazole in Patients With Acute SchizophreniaSchizophreniaNCT01810380H. Lundbeck A/S468