2024-515338-34-01招募中4 期
Biomarkers in clozapine-responding schizophrenia
Psykiatrisk Center Glostrup1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Permeability of the blood-brain barrier blood and CSF inflammatory cytokines
研究概览
简要总结
biomarkers predicting clozapine response
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •According to ICD-10 fulfill diagnostic criteria of schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/29)
- •Age 18-64 years
- •Legally competent
- •Stable antipsychotic treatment during the 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).
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)
- •Females who are breastfeeding
- •Toxic or idiosyncratic agranulocytosis in the past
- •Reduced bone marrow function according to blood samples (normal function defined as leucocytes > 3.3*109/l and neutrophil > 2.0*109/l)
- •According to information from patient and available files, no o Current uncontrolled epilepsy o Current circulatory collapse and / or CNS depression for any cause o Current severe kidney, heart or liver disease o Current paralytic ileus
结局指标
主要结局
Permeability of the blood-brain barrier blood and CSF inflammatory cytokines
Permeability of the blood-brain barrier blood and CSF inflammatory cytokines
次要结局
未报告次要终点
研究者
Jimmi Nielsen
Scientific
Psykiatrisk Center Glostrup
研究点 (1)
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