NL-OMON48672已完成4 期
Influence of dose interval on the pharmacokinetics of both unbound and total fractions of clozapine and norclozapine in psychiatric patients in the Netherlands - INPUT study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age *18 * 70 years
- •* Clozapine use BID or OID
- •* Capacity to speak and read the Dutch language.
- •* Mental competency and decisional capacity with regard to participation in the current study
- •* Absence of active suicidality
- •* Clozapine use in *steady state* (i.e. same dose and frequency for *7 days)
- •* Signed Informed consent
排除标准
- •* *inbewaringstelling* (IBS)
- •* *rechterlijke machtiging* (RM)
- •* Pregnancy (if known)
- •* Initiation, cessation or dose change of the following co-medication within 7 days prior to blood sampling:
- •o Fluvoxamine
- •o Hormonal anti-conceptive,
- •o Ciprofloxacin,
- •o Phenytoin,
- •o Valproic acid,
- •o Carbamazepine
- •o Rifampicin.
- •* Acute inflammation / infection (derived from having fever (i.e. body temperature >38.0 degrees Celsius and/or using an antibiotic at time of blood sampling).
- •* Smoking (of tobacco containing products) initiation or cessation < 7 days before participation
研究者
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