Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable.
The primary aim of this study is to investigate:
- . whether the early prediction model used in other atypicals could also be applied in paliperidone ER.
- . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study
详细描述
Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.
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
- •diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- •a minimal baseline total score of 60 on the PANSS
- •those who had not received long-acting antipsychotic injection for the preceding 6 months
- •physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.
排除标准
- •diagnosis of substance (including alcohol) dependence in the previous 6 months
- •a medical condition that could affect absorption, metabolism, or excretion of the study drug
- •substantial risk of suicide or violent behavior
- •pregnancy or breastfeeding
- •documented organic disease of the central nervous system
- •unstable or critical untreated medical illness
- •history of clozapine treatment in the previous 3 months
- •participation in an investigational drug trial in the 30 days before screening.
研究组 & 干预措施
Paliperidone Extended Release (ER)
The participants were assigned to receive a fixed dosage of 9 mg/d of paliperidone ER for the first 2 weeks. The paliperidone ER dosage was adjusted flexibly after 2 weeks according to the clinical judgment of the physicians in charge.
干预措施: Paliperidone ER (Drug)
结局指标
主要结局
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)
时间窗: Baseline (day 0) and Day 42
次要结局
- Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)(Day 0 and 42)