A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 394
- 主要终点
- Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.
详细描述
This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given their own consent in writing to participate in the study
- •Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
- •Patients who have acute symptoms of schizophrenia
- •Both inpatients and outpatients are acceptable
排除标准
- •A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
- •A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
- •Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
- •Patients treated with three or more types of antipsychotic within 28 days before the screening test
- •Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
- •Patients with a complication of or a past history of cerebrovascular accident
- •Patients with a complication of or a past history of diabetes mellitus
研究组 & 干预措施
ER OROS paliperidone
Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
干预措施: ER OROS paliperidone (Drug)
Placebo
干预措施: Placebo (Drug)
Olanzapine
干预措施: Olanzapine (Drug)
结局指标
主要结局
Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
时间窗: Baseline and 6 weeks
PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
次要结局
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score(Baseline and 6 weeks)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score(Baseline and 6 weeks)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score(Baseline and 6 weeks)
- Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])(Baseline and 6 weeks)
- Change From Baseline in Clinical Global Impression Scale (CGI-S)(Baseline and 6 weeks)