A Randomised, Double-blind, Parallel-group, Flexible-dose Trial Evaluating the Efficacy and Safety of 12 Weeks of Treatment With Sertindole or Olanzapine in Patients With Schizophrenia in Asia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.
详细描述
This study is the first randomised clinical trial performed in Asia with sertindole, aiming at comparing sertindole efficacy and safety to that of another atypical antipsychotic.
Sertindole is a limbic-selective antipsychotic agent with a unique neuropharmacological profile. Sertindole has shown significant improvements relative to placebo against both positive and negative symptoms of schizophrenia (measured by PANSS total, PANSS negative and positive subscale scores). It is well tolerated and shows placebo-level incidence of extrapyramidal symptoms (EPS). Sertindole is associated with a dose-dependent increase in the QT interval, but this does not translate into an excess mortality with sertindole relative to that of other recently developed antipsychotics in their respective clinical development programmes.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia
- •Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline
- •Based on the patient's clinical status, an antipsychotic treatment is indicated
- •Otherwise healthy
- •Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods
排除标准
- •Current Axis I primary psychiatric diagnosis other than schizophrenia
- •Has never before received antipsychotic drugs
- •Has received a depot antipsychotic medication within less than one dose interval prior to Screening
- •History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)
- •Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening)
- •Significant risk of suicide and/or violent behaviour
- •Known history of narrow angle glaucoma
- •Substance or alcohol abuse, current alcohol dependence
- •Use of disallowed concomitant medication
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Sertindole
干预措施: Sertindole (Drug)
Olanzapine
干预措施: Olanzapine (Drug)
结局指标
主要结局
To evaluate the efficacy of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.
时间窗: 12 weeks
次要结局
- To evaluate the safety and tolerability of 12 weeks treatment with flexible doses of sertindole in comparison to flexible doses of olanzapine in patients with schizophrenia.(12 weeks)