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Clinical Trials/ISRCTN18352058
ISRCTN18352058
Completed
未知

The clinical effectiveness and cost effectiveness of clozapine for inpatients with borderline personality disorder: randomised controlled trial

Imperial College of Science, Technology and Medicine0 sites29 target enrollmentMarch 26, 2019

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)

Registry
who.int
Start Date
March 26, 2019
End Date
July 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Sex
All

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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