A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 366
- 主要终点
- The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response study of patients who have a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) diagnosis of schizophrenia. The duration of the study is approximately 14 weeks, including a screening period of 1 week and a 13-week double-blind treatment period. Efficacy and safety will be evaluated periodically throughout the study. Samples for pharmacokinetic evaluation will be collected at designated time points, and a blood sample will be collected at baseline (before the start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis. The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. The effectiveness is measured primarily by the change in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), and secondarily, by the investigator's Clinical Global Impression of Severity (CGI-S) and by the investigator's evaluation of the patient on a Personal and Social Performance (PSP) Scale. Four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent administered in the gluteal muscle (buttocks). Injections will be given on Days 1, 8, 36, and 64 of the double-blind treatment period of the study.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A DSM-IV diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated type) for at least 1 year before the screening evaluation
- •a total PANSS score of 70 to 120 at screening and baseline (pre-treatment) evaluations
- •a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of more than 17.0 kg/m²
排除标准
- •A primary active DSM-IV Axis I diagnosis other than schizophrenia
- •a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
- •a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
- •a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
- •a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.
结局指标
主要结局
The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
次要结局
- The investigator's Clinical Global Impression of the Severity (CGI-S) of schizophrenia and rating of mental function on a Personal and Social Performance Scale (PSP). Evaluations of adverse events, laboratory tests, and other measures of drug safety.