Young woman with head in hands

The clinical effectiveness and cost-effectiveness of clozapine for inpatients with severe borderline personality disorder (CALMED) study

Overview

Over a million people are affected by borderline personality disorder in Britain. People with these problems can experience sudden and distressing changes in mood, negative feelings about themselves and difficulties in relationships with others. People with borderline personality disorder sometimes act in ways which pose risks to themselves or to others, which can lead to an admission to hospital. At present, there is no effective drug treatment for people with a borderline personality disorder. In recent years doctors have tried using ‘clozapine’, an antipsychotic drug which is effective in treating other mental health conditions. There have been reports that it can improve the mental health of inpatients with severe borderline personality disorder, but evidence from trials to support its use is lacking.

The purpose of the CALMED study is to find out whether clozapine improves the mental health and quality of life for people with borderline personality disorder and reduces the amount of time they spend in hospital.  We hope this study will be able to help doctors, patients and carers make better decisions about prescribing for people with severe borderline personality disorder in the future.

We are recruiting people who are receiving treatment as inpatients for borderline personality disorder and been referred to the study by a member of their clinical team. The study will compare a group of people that take capsules containing clozapine to another group that take placebo capsules, which do not contain clozapine. Our research teams will follow participants up for 6 months using questionnaires to assess mental health and will not know whether people are prescribed clozapine or the placebo. This allows for a fair assessment of the effectiveness of clozapine.

Everyone that takes part in the study will have their blood checked regularly. This is because clozapine can cause a significant reduction in white blood cells, a condition known as agranulocytosis.

Key information