Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PANSS total score
研究概览
简要总结
The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.
详细描述
Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •ICD10 diagnosis of schizophrenia (F20.0-3)
- •Clozapine treatment minimum 6 months
- •Total PANSS >65
- •No antipsychotic other than clozapine drug 1 month prior inclusion
排除标准
- •QTc >500 ms
- •Violence to SPC of clozapine or Serdolect
- •Major depression
- •Significant substance misuse interfering with participating in the study
- •Cardiovascular disease
研究组 & 干预措施
A
Sertindole 16 mg
干预措施: Serdolect (Drug)
B
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
PANSS total score
时间窗: 12 weeks
次要结局
- GAF(12 weeks)
- WHOQOL-BREF(12 weeks)
- CGI(12 weeks)
- DAI(12 weeks)
- Cognitive test(12 weeks)
- Fasting glucose(12 weeks)
- Lipids(12 weeks)
- Hb1Ac(12 weeks)