EUCTR2018-002471-18-GB
Active, not recruiting
Phase 1
The clinical effectiveness and cost effectiveness of clozapine for inpatients with borderline personality disorder: randomised controlled trial - CALMED
DrugsClozaril
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imperial College London
- Enrollment
- 222
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
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\) 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
Exclusion Criteria
- •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:
Outcomes
Primary Outcomes
Not specified
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