Clozapine in the treatment of borderline personality disorder. The CALMED study.

Not Applicable

Completed

• Conditions: Borderline personality disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN18352058
• Lead Sponsor: Imperial College of Science, Technology and Medicine

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35510087/ (added 09/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-26
• Study Completion: 2021-07-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 29

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score on the Zanarini rating scale for Borderline Personality Disorder (ZAN-BPD) at six months (primary end point)