ISRCTN18352058
Completed
未知
The clinical effectiveness and cost effectiveness of clozapine for inpatients with borderline personality disorder: randomised controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imperial College of Science, Technology and Medicine
- Enrollment
- 29
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35510087/ (added 09/08/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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