EUCTR2006-002682-40-DK进行中（未招募）1 期
Augmenting clozapine with sertindole - A double-blinded randomized placebo study (SERCLOZ) - SERCLOZ
Aalborg Psychiatric Hospital, Research Unit0 个研究点目标入组 50 人开始时间: 2006年8月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Both sexes, 18-65 years.
- •Minimum treatment with clozapine for six months
- •Fixed dosage dosage of clozapine and other psychotropics last month prior inclusion except for benzodiazepines and anticholinergics.
- •No other antipsychotic during the study than sertindole and clozapine
- •PANSS score more than 65
- •Informed consent given
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Clinical important cardiovascular disease
- •Prescribing other antipsychotics than clozapine
- •Compulsory measures
- •QT prolongation to more than 500 ms.
- •Concomitant potent CYP2D6 inhibitors
- •ICD-10 Major depression
- •Disruption of clozapine bloodsamples
- •Disruption of SPC of Serdolect and clozapine
研究者
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