CALMED
Research type
Research Study
Full title
The clinical effectiveness and cost effectiveness of clozapine for inpatients with borderline personality disorder: randomised controlled trial
IRAS ID
248777
Contact name
Mike Crawford
Contact email
Sponsor organisation
Imperial College London
Eudract number
2018-002471-18
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
People with borderline personality disorder experience rapid and distressing changes in mood and difficulties in their relationships with others. These problems can lead to impulsive aggression, deliberate self-harm and suicide. People with borderline personality disorder are often given medication, but no drugs are licensed for this condition. 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 mental health of inpatients with borderline personality disorder, but the drug has serious side effects which can be life-threatening and no clinical trials have been conducted.
We plan to conduct a randomised trial to examine the clinical and cost-effectiveness of clozapine versus placebo for inpatients with borderline personality disorder. We will recruit people aged 18 years or over who are inpatients, have a confirmed diagnosis, and have failed to make an adequate response to existing treatment despite taking other antipsychotic drugs for at least three months. We will exclude people who have a clinical diagnosis of psychosis and those already taking clozapine.
We will recruit 222 people from inpatient services across England. At the start of the study we will assess patients’ mental health, self-harm, aggressive behaviour, health-related quality of life, side effects of treatment and costs of care. Each person in the study would have an equal chance of receiving clozapine or placebo in addition to the care they would normally receive. Researchers will conduct follow-up assessments at three and six months, and will not know whether people are being prescribed clozapine or the placebo.
We believe that this study can help ensure that inpatients with borderline personality disorder get the best and safest treatment for their condition and that funding is used in the most effective way.
REC name
Wales REC 1
REC reference
18/WA/0382
Date of REC Opinion
18 Dec 2018
REC opinion
Further Information Favourable Opinion