EUCTR2018-002471-18-GB进行中（未招募）1 期
The clinical effectiveness and cost effectiveness of clozapine for inpatients with borderline personality disorder: randomised controlled trial - CALMED
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 222
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
- •1) Aged 18 years or over
- •2) Currently an inpatient on a mental health unit
- •3) Meeting DSM-IV diagnostic criteria for borderline personality disorder
- •4) Failure to make an adequate clinical response to taking antipsychotic medication other than clozapine for at least three months
- •5) Have a satisfactory pre-treatment full blood count (white blood cell count >=3.5 and absolute neutrophil count >=2.0)
- •6) Have had their weight and blood glucose recoded in their clinical records
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 219
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •We will exclude those who:
- •1) have a current clinical diagnosis of schizophrenia, or bipolar I disorder
- •2) prescribed clozapine within the last two weeks
- •3) are known to be pregnant, trying to conceive, breastfeeding, or a woman of childbearing potential and is not using a highly
- •effective birth control.
- •4) are due to be discharged from the unit within the following two weeks
- •5) are unable to speak sufficient English to complete the baseline assessment
- •6) are unwilling or unable to provide written informed consent to take part in the study
- •7) are unable to undergo regular blood tests
- •8) have a contraindication to clozapine or other listed condition, namely:
- •9) have a known history of primary bone marrow disorders or impaired bone marrow function
- •10) severe renal or cardiac disorders (e.g. myocarditis), or a known history of cardiac illness or abnormal cardiac findings on physical examination
- •11) have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •12) have hypersensitivity to
- •-Magnesium stearate
- •-Silica, colloidal anhydrous
- •-Povidone K30
- •-Maize starch
- •-Lactose monohydrate
- •13) have a known history of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy)
- •14) have a history of clozapine-induced agranulocytosis
- •15) have uncontrolled epilepsy
- •16) have alcoholic and other toxic psychoses, drug intoxication, comatose conditions
- •17) Have circulatory collapse and/or CNS depression of any cause
- •18) Have active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure
- •19) Have paralytic ileus
研究者
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