ISRCTN18352058已完成未知
The clinical effectiveness and cost effectiveness of clozapine for inpatients with borderline personality disorder: randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 29
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35510087/ (added 09/08/2022)
研究设计
- 研究类型
- Interventional
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. Satisfactory pre-treatment full blood count (white blood cell count > = 3.5 and absolute neutrophil count > = 2.0)
- •6. Weight and blood glucose recorded in their clinical records
- •(added 08/01/2020)
- •7. Have been an inpatient on a mental health ward for more than 28 days in the last 12 months, OR have had two or more admissions to hospital/ periods of care provided by Home Treatment over the last 12 months, AND a lifetime history of two or more incidents of harm to self or others which resulted in permanent damage/ disability, or would have done so had services not intervened
排除标准
- •1. Current clinical diagnosis of schizophrenia, or bipolar I disorder
- •2. Prescribed clozapine within the last two weeks
- •3. Pregnant, trying to conceive, breastfeeding, or a woman of childbearing potential and is not using a highly
- •effective birth control.
- •4. Due to be discharged from the unit within the following two weeks and it is not possible to continue the necessary monitoring of physical health as an outpatient (updated 21/08/2019, previously: Due to be discharged from the unit within the following two weeks)
- •5. Unable to speak sufficient English to complete the baseline assessment
- •6. Unwilling or unable to provide written informed consent to take part in the study
- •7. Unable to undergo regular blood tests
- •8. Contraindication to clozapine or other listed condition, namely:
- •9. 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. Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •12. Hypersensitivity to: Magnesium stearate; Silica, colloidal anhydrous; Povidone K30; Talc; Maize starch; Lactose monohydrate
- •13. History of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy)
- •14. History of clozapine-induced agranulocytosis
- •15. Uncontrolled epilepsy
- •16. Alcoholic and other toxic psychoses, drug intoxication, comatose conditions
- •17. Circulatory collapse and/or CNS depression of any cause
- •18. Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure
- •19. Paralytic ileus
研究者
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