A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
- •experiencing an acute exacerbation of psychosis
排除标准
- •any subject unable to provide informed consent
- •any female subject who is pregnant or breast-feeding
- •any subject judged to be medically inappropriate for study participation
研究组 & 干预措施
Lumateperone 14 mg (ITI-007 20 mg Tosylate)
Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
干预措施: ITI-007 (Drug)
Lumateperone 42 mg (ITI-007 60 mg Tosylate)
Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
干预措施: ITI-007 (Drug)
Placebo
Placebo administered orally as visually-matched capsules once daily for 6 weeks
干预措施: Placebo (Drug)
Risperidone
Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks
干预措施: Risperidone (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: 6 weeks
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating more severe symptoms.
次要结局
- Change From Baseline to Week 6 in Clinical Global Impressions-Severity of Illness Scale(6 weeks)