An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 212
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).
详细描述
This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants. This study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit. Safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 13 weeks.
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
- •Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
- •Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia
- •Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening
- •Agree to protocol-defined method of contraception
- •Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening
排除标准
- •Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
- •Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination
- •Have a history of neuroleptic malignant syndrome
- •Participants at risk of suicide
- •Have received clozapine within 1 month prior to Screening
研究组 & 干预措施
Paliperidone palmitate
干预措施: Paliperidone palmitate (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline (Week 0), Week 13
The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated on a scale of 1 (absent) to 7 (extreme). 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) Marder Factor Scores(Baseline, Week 13)
- Change From Baseline in Personal and Social Performance (PSP) Scale Score(Baseline, Week 13)
- Number of Participants With Drug Discontinuation(Up to Week 13)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores(Baseline, Week 13)
- Time to Readiness for Hospitalization Discharge for Inpatients Using the Readiness for Discharge Questionnaire (RDQ) Scale(Baseline up to Week 13)
- Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline, Week 13)
- Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score(Baseline, Week 13)