NCT02901587已完成1 期
Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Change from time-matched baseline on day 1, 21, and 42 in QTcF
研究概览
简要总结
The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is able by her/himself to provide informed consent to participate in the study
- •The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)
- •The patient has BMI ≤35 kg/m2
- •The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill)
- •PANSS total score ≤ 80 and a score ≤4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)
- •The patient is willing to be hospitalized for up to 8 weeks
- •The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.
- •The patient agrees to protocol-defined use of effective contraception
排除标准
- •The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks
- •The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months
- •The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)
- •The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Lu AF35700 (10 mg/day)
Experimental
Lu AF35700 10 mg/day for 6 weeks
干预措施: Lu AF35700 (10 mg/day) (Drug)
Lu AF35700 (30 mg/day)
Experimental
Lu AF35700 30 mg/day for 6 weeks
干预措施: Lu AF35700 (30 mg/day) (Drug)
Quetiapine (Seroquel XR® 800 mg/day)
Experimental
Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks
干预措施: Quetiapine (Seroquel XR® 800 mg/day) (Drug)
结局指标
主要结局
Change from time-matched baseline on day 1, 21, and 42 in QTcF
时间窗: Before dose to 10 hours post dose
次要结局
未报告次要终点
研究者
研究点 (1)
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