A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 28 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 whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.
详细描述
The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.
Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's age is 18-55
- •Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
- •Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years
排除标准
- •Any female patient who is pregnant or breast-feeding
- •Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
- •Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
- •Any patient considered to be an imminent danger to themselves or others
- •Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
- •Any patient judged by the Investigator to be inappropriate for the study
研究组 & 干预措施
ITI-007 Low Dose
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
干预措施: ITI-007 (Drug)
ITI-007 Low Dose
Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
干预措施: Placebo (Drug)
ITI-007 High Dose
Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
干预措施: ITI-007 (Drug)
Placebo
Placebo: Capsules containing inactive placebo administered for 28 days
干预措施: Placebo (Drug)
Risperidone
Risperidone: Capsules containing 4 mg risperidone administered for 28 days
干预措施: Risperidone (Drug)
结局指标
主要结局
Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Change from baseline to Day 28
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 Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score(Change from Baseline to Day 8)
- Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score(Change from Baseline to Day 15)
- Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score(Change from Baseline to Day 22)