Imperial College London
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DrVerityLeeson

Faculty of Medicine, Department of Brain Sciences

Clinical Trials Manager
 
 
 
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Contact

 

v.leeson

 
 
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Location

 

Clinical Trials OfficeCommonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Barnes:2018:10.1177/2045125318762365,
author = {Barnes, TRE and Leeson, V and Paton, C and Marston, L and Osborn, D and Kumar, R and Keown, P and Zafar, R and Iqbal, K and Singh, V and Fridrich, P and Fitzgerald, Z and Bagalkote, H and Haddad, P and Husni, M and Amos, T},
doi = {10.1177/2045125318762365},
journal = {Therapeutic Advances in Psychopharmacology},
pages = {185--197},
title = {Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial},
url = {http://dx.doi.org/10.1177/2045125318762365},
volume = {8},
year = {2018}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background:A second antipsychotic is commonly added to clozapine to treat refractory schizophrenia, notwithstanding the limited evidence to support such practice.Methods:The efficacy and adverse effects of this pharmacological strategy were examined in a double-blind, placebo-controlled, 12-week randomized trial of clozapine augmentation with amisulpride, involving 68 adults with treatment-resistant schizophrenia and persistent symptoms despite a predefined trial of clozapine.Results:There were no statistically significant differences between the amisulpride and placebo groups on the primary outcome measure (clinical response defined as a 20% reduction in total Positive and Negative Syndrome Scale score) or other mental state measures. However, the trial under recruited and was therefore underpowered to detect differences in the primary outcome, meaning that acceptance of the null hypothesis carries an increased risk of type II error. The findings suggested that amisulpride-treated participants were more likely to fulfil the clinical response criterion, odds ratio 1.17 (95% confidence interval 0.40–3.42) and have a greater reduction in negative symptoms, but these numerical differences were not statistically significant and only evident at 12 weeks. A significantly higher proportion of participants in the amisulpride group had at least one adverse event compared with the control group (p = 0.014), and these were more likely to be cardiac symptoms.Conclusions:Treatment for more than 6 weeks may be required for an adequate trial of clozapine augmentation with amisulpride. The greater side-effect burden associated with this treatment strategy highlights the need for safety and tolerability monitoring, including vigilance for indicators of cardiac abnormalities, when it is used in either a clinical or research setting.
AU  - Barnes,TRE
AU  - Leeson,V
AU  - Paton,C
AU  - Marston,L
AU  - Osborn,D
AU  - Kumar,R
AU  - Keown,P
AU  - Zafar,R
AU  - Iqbal,K
AU  - Singh,V
AU  - Fridrich,P
AU  - Fitzgerald,Z
AU  - Bagalkote,H
AU  - Haddad,P
AU  - Husni,M
AU  - Amos,T
DO  - 10.1177/2045125318762365
EP  - 197
PY  - 2018///
SN  - 2045-1253
SP  - 185
TI  - Amisulpride augmentation of clozapine for treatment-refractory schizophrenia: a double-blind, placebo-controlled trial
T2  - Therapeutic Advances in Psychopharmacology
UR  - http://dx.doi.org/10.1177/2045125318762365
UR  - http://hdl.handle.net/10044/1/56489
VL  - 8
ER  -
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