An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 188
- 主要终点
- The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
研究概览
简要总结
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
详细描述
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.
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
- •Patients diagnosed with schizophrenia
- •Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
- •Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
- •Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
- •Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
排除标准
- •Serious unstable medical condition, including known clinically relevant laboratory abnormalities
- •Judged to be at high risk for adverse events, violence or self-harm
- •Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
- •Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
- •Patients with a current use or known history (over the past 6 months) of substance dependence
- •Positive urine drug examination
研究组 & 干预措施
Paliperidone ER
干预措施: Paliperidone ER (Drug)
结局指标
主要结局
The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
时间窗: Baseline, Day 90
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
次要结局
- Patient Satisfaction With Paliperidone Treatment(90 days)
- Positive and Negative Syndrome Scale (PANSS) Scores at Day 90(Day 90)
- Quality of Sleep at Baseline(Baseline)
- Daytime Drowsiness at Baseline(Baseline)
- Positive and Negative Syndrome Scale (PANSS) Scores at Baseline(Baseline)
- Clinical Global Impression-Severity (CGIS) Scores at Baseline(Baseline)
- Clinical Global Impression-Severity (CGIS) Scores at Day 90(Day 90)
- Personal and Social Performance (PSP) Scores at Baseline(Baseline)
- Daytime Drowsiness at Day 90(Day 90)
- Personal and Social Performance (PSP) Scores at Day 90(Day 90)
- Quality of Sleep at Day 90(Day 90)