REFRESH : Randomized Double-blind, Placebo-controlled, Multicenter Trial to Assess the Safety and Efficacy of RP5063 in Subjects With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.
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
- Triple (Participant, Care Provider, Investigator)
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 providing informed consent prior to any study specific procedures
- •Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder
- •Patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ECG)
排除标准
- •Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder
研究组 & 干预措施
15 mg RP5063 daily
RP5063 15 mg once daily
干预措施: RP5063 (Drug)
30 mg RP5063 daily
RP5063 30 mg once daily
干预措施: RP5063 (Drug)
50 mg RP5063 daily
RP5063 50 mg once daily
干预措施: RP5063 (Drug)
Placebo
Placebo once daily
干预措施: placebo (Drug)
aripiprazole
aripiprazole 15 mg daily
干预措施: aripiprazole (Drug)
结局指标
主要结局
Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline to Day 28
PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.
次要结局
- Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)(Baseline to Day 28)
- Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale(Baseline to Day 28)
- Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale(Baseline to Day 28)
- Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale(Baseline to Day 28)