Borderline personality disorder Mental and Behavioural Disorders Borderline personality disorder
Conditions
Interventions
Study participants in the active arm of the trial will be prescribed a dose of up to 400mg of clozapine daily, depending on clinical response, patient preference and side effects.
Thos
Sponsors
Imperial College of Science, Technology and Medicine
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score on the Zanarini rating scale for Borderline Personality Disorder (ZAN-BPD) at six months (primary end point) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total score on the Zanarini rating scale for Borderline Personality Disorder at three months. 2. General mental health using the Brief Psychiatric Rating Scale (BPRS) at three and six months. 3. Incidence and severity of suicidal behaviour using the Acts of Deliberate Self-Harm Inventory. 4. Level of aggressive behaviour using the Modified Overt Aggression Scale 5. Health related quality of life using the EQ-5D-5L. 6. Side effects of medication using the Antipsychotic Non-Neurological Side Effects Scale (ANNSERS) and motor and extrapyramidal side effects using the Extrapyramidal Side Effects Scale. 7. Incidence of withdrawal of trial medication due to adverse effects. 8. Medication adherence at three and six months using the Brief Adherence Rating Scale. 9. Resource use collected using a modified version of the Adult Service Use Schedule and by examining clinical records at six, 12 and 18 months. This will include detailed information about length of inpatient treatment and type of ward (high, medium, low secure, Psychiatric Intensive Care, general adult etc.), contacts with community mental health services and emergency medical services, and the type and dose of psychotropic medication that people are prescribed. | — |
Countries
England, United Kingdom
Outcome results
None listed