Imperial College London
Portrait Picture

DrVerityLeeson

Faculty of Medicine, Department of Brain Sciences

Clinical Trials Manager
 
 
 
//

Contact

 

v.leeson

 
 
//

Location

 

Clinical Trials OfficeCommonwealth BuildingHammersmith Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Crawford:2022:10.1177/20451253221090832,
author = {Crawford, M and Leeson, V and Evans, R and Barrett, B and McQuaid, A and Cheshire, J and Sanatina, R and Lamph, G and Sen, P and Anagnostakis, K and Millard, L and Qurashi, I and Larkin, F and Husain, N and Moran, P and Barnes, T and Paton, C and Hoare, Z and Picchioni, M and Gibbon, S},
doi = {10.1177/20451253221090832},
journal = {Therapeutic Advances in Psychopharmacology},
pages = {1--14},
title = {The clinical effectiveness and cost effectiveness of clozapine for inpatients with severe borderline personality disorder (CALMED study): A randomised placebo-controlled trial.},
url = {http://dx.doi.org/10.1177/20451253221090832},
volume = {12},
year = {2022}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background:Data from case series suggest that clozapine may benefit inpatients with borderline personality disorder (BPD), but randomised trials have not been conducted. Methods:Multicentre, double-blind, placebo-controlled trial. We aimed to recruit 222 inpatients with severe BPD aged 18 or over, who had failed to respond to other antipsychotic medications. We randomly allocated participants on a 1:1 ratio to receive up to 400mg of clozapine per day or an inert placebo using a remote web-based randomisation service. The primary outcome was total score on the Zanarini Rating scale for Borderline Personality Disorder (ZAN-BPD) at six months. Secondary outcomes included self-harm, aggression, resource use and costs, side effects and adverse events. We used a modified intention to treat analysis (mITT) restricted to those who took one or more dose of trial medication, using a general linear model fitted at six months adjusted for baseline score, allocation group and site. Results:The study closed early due to poor recruitment and the impact of the COVID-19 pandemic. Of 29 study participants, 24 (83%) were followed up at six months, of whom 21 (72%) were included in the mITT analysis. At six months, 11 (73%) participants assigned to clozapine and 6 (43%) of those assigned to placebo were still taking trial medication. Adjusted difference in mean total ZAN-BPD score at six months was -3.86 (95% Confidence Intervals = -10.04 to 2.32, p=0.22). There were 14 serious adverse events; six in the clozapine arm and eight in the placebo arm of the trial.  There was little difference in the cost of care between groups.  Interpretation:We recruited insufficient participants to test the primary hypothesis. The study findings highlight problems in conducting placebo-controlled trials of clozapine and in using clozapine for people with BPD, outside specialist inpatient mental health units.Trial registrationISRCTN18352058. https://doi.org/10.1186/ISRCTN18352058
AU  - Crawford,M
AU  - Leeson,V
AU  - Evans,R
AU  - Barrett,B
AU  - McQuaid,A
AU  - Cheshire,J
AU  - Sanatina,R
AU  - Lamph,G
AU  - Sen,P
AU  - Anagnostakis,K
AU  - Millard,L
AU  - Qurashi,I
AU  - Larkin,F
AU  - Husain,N
AU  - Moran,P
AU  - Barnes,T
AU  - Paton,C
AU  - Hoare,Z
AU  - Picchioni,M
AU  - Gibbon,S
DO  - 10.1177/20451253221090832
EP  - 14
PY  - 2022///
SN  - 2045-1253
SP  - 1
TI  - The clinical effectiveness and cost effectiveness of clozapine for inpatients with severe borderline personality disorder (CALMED study): A randomised placebo-controlled trial.
T2  - Therapeutic Advances in Psychopharmacology
UR  - http://dx.doi.org/10.1177/20451253221090832
UR  - https://journals.sagepub.com/doi/10.1177/20451253221090832
UR  - http://hdl.handle.net/10044/1/96268
VL  - 12
ER  -
Download