A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
研究概览
简要总结
The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, men and women, aged 18 to
- •Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
- •Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.
排除标准
- •Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
- •Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
- •Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
研究组 & 干预措施
1
干预措施: vabicaserin (Drug)
2
4mg/day
干预措施: risperidone (Drug)
3
matching placebo
干预措施: placebo (Other)
结局指标
主要结局
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
时间窗: Baseline
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
时间窗: Baseline, Day 28
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
次要结局
- Positive and Negative Symptom Scale (PANSS) Positive Subscale Score(Baseline, Day 7, 14, 21, 28)
- Positive and Negative Symptom Scale (PANSS) Negative Subscale Score(Baseline, Day 7, 14, 21, 28)
- Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score(Baseline, Day 7, 14, 21, 28)
- Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score(Baseline, Day 7, 14, 21, 28)
- Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score(Baseline, Day 7, 14, 21, 28)
- Clinical Global Impression - Severity (CGI-S) Score(Baseline, Day 7, 14, 21, 28)
- Clinical Global Impression - Improvement (CGI-I) Score(Day 7, 14, 21, 28)
- Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline, Day 7, 14, 21, 28)