Clozapine in the treatment of borderline personality disorder

Phase 1

• Conditions: Borderline Personality Disorder; MedDRA version: 21.1Level: PTClassification code 10006034Term: Borderline personality disorderSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2018-002471-18-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 222

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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:
9) have a 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) have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
12) have hypersensitivity to
-Magnesium stearate
-Silica, colloidal anhydrous
-Povidone K30
-Talc
-Maize starch
-Lactose monohydrate
13) have a known history of toxic or idiosyncratic granulocytopenia/agranulocytosis (with the exception of granulocytopenia/agranulocytosis from previous chemotherapy)
14) have a history of clozapine-induced agranulocytosis
15) have uncontrolled epilepsy
16) have alcoholic and other toxic psychoses, drug intoxication, comatose conditions
17) Have circulatory collapse and/or CNS depression of any cause
18) Have active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure
19) Have paralytic ileus

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified