An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 353
- 主要终点
- Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
详细描述
This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [Edition 4] criteria)
- •Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
- •Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- •Participants who are capable of and willing to fill out the questionnaire for themselves
- •Participants who are compliant with self-medication or can receive consistent help or support
排除标准
- •Participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
- •Participants with allergy or hypersensitivity to risperidone or paliperidone
- •Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
- •Participants who have been treated with the long acting antipsychotic injection within 28 days
- •Participants with significant risk including suicide or aggressive behavior
研究组 & 干预措施
Paliperidone Extended Release (ER)
干预措施: Paliperidone ER (Drug)
结局指标
主要结局
Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
时间窗: Week 12
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
次要结局
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12(Baseline, Week 12)
- Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score(Week 12)
- Change From Baseline in Personal and Social Performance (PSP) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12(Baseline, Week 12)