EUCTR2019-003128-19-DK进行中（未招募）1 期
Biomarkers in Clozapine-responding Schizophrenia - BiCS
Psykiatrisk Center Glostrup0 个研究点目标入组 200 人开始时间: 2019年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
入选标准
- •According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/F29);
- •Age 18-64 years;
- •Legally competent;
- •Stable antipsychotic treatment during last month
- •Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (=600 mg clorpromazine equivalent) for a sufficient time (= 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms).
- •Recreational use of substances is allowed as long as it does not interfere with compliance
- •Fertile females must use safe contraception (spiral or any hormonal contraception).
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Involuntarily psychiatric admittance during the study
- •Substance abuse that interfere with compliance
- •Any condition that interfere with compliance for obtaining bloodsamples weekly
- •Pregnancy (will be verified by urine-HCG-test in fertile females)
- •Toxic or idiosyncratic agranulocytosis in the past
- •Reduced bone marrow function according to blood samples
- •According to information from patient and available files, no
- •-current uncontrolled epilepsy
- •-current circulatory collapse and/or CNS depression for any cause
- •-current severe kidney, heart or liver disease
- •-current paralytic ileus
研究者
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