Melissa Pyle
Design and protocol for the Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial
Pyle, Melissa; Schwannauer, Matthias; Norrie, John; Kingdon, David; Gumley, Andrew; Turkington, Douglas; Byrne, Rory; Syrett, Suzy; MacLennan, Graeme; Dudley, Robert; McLeod, Hamish J.; Griffiths, Helen; Bowe, Samantha; Barnes, Thomas R. E.; French, Paul; Hutton, Paul; Davies, Linda; Morrison, Anthony P.
Authors
Matthias Schwannauer
John Norrie
David Kingdon
Andrew Gumley
Douglas Turkington
Rory Byrne
Suzy Syrett
Graeme MacLennan
Robert Dudley
Hamish J. McLeod
Helen Griffiths
Samantha Bowe
Thomas R. E. Barnes
Paul French
Prof Paul Hutton P.Hutton@napier.ac.uk
Professor
Linda Davies
Anthony P. Morrison
Abstract
Background
For around a third of people with a diagnosis of schizophrenia, the condition proves to respond poorly to treatment with many typical and atypical antipsychotics. This is commonly referred to as treatment-resistant schizophrenia. Clozapine is the only antipsychotic with convincing efficacy for people whose symptoms are considered treatment-resistant to antipsychotic medication. However, 30–40 % of such conditions will have an insufficient response to the drug. Cognitive behavioural therapy has been shown to be an effective treatment for schizophrenia when delivered in combination with antipsychotic medication, with several meta-analyses showing robust support for this approach. However, the evidence for the effectiveness of cognitive behavioural therapy for people with a schizophrenia diagnosis whose symptoms are treatment-resistant to antipsychotic medication is limited. There is a clinical and economic need to evaluate treatments to improve outcomes for people with such conditions.
Methods/design
A parallel group, prospective randomised, open, blinded evaluation of outcomes design will be used to compare a standardised cognitive behavioural therapy intervention added to treatment as usual versus treatment as usual alone (the comparator group) for individuals with a diagnosis of schizophrenia for whom an adequate trial of clozapine has either not been possible due to tolerability problems or was not associated with a sufficient therapeutic response. The trial will be conducted across five sites in the United Kingdom.
Discussion
The recruitment target of 485 was achieved, with a final recruitment total of 487. This trial is the largest definitive, pragmatic clinical and cost-effectiveness trial of cognitive behavioural therapy for people with schizophrenia whose symptoms have failed to show an adequate response to clozapine treatment. Using a prognostic risk model, baseline information will be used to explore whether there are identifiable subgroups for which the treatment effect is greatest.
Trial registration
Current Controlled Trials ISRCTN99672552. Registered 29th November 2012.
Citation
Pyle, M., Schwannauer, M., Norrie, J., Kingdon, D., Gumley, A., Turkington, D., Byrne, R., Syrett, S., MacLennan, G., Dudley, R., McLeod, H. J., Griffiths, H., Bowe, S., Barnes, T. R. E., French, P., Hutton, P., Davies, L., & Morrison, A. P. (2016). Design and protocol for the Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial. BMC Psychiatry, 16(280), https://doi.org/10.1186/s12888-016-0983-6
Journal Article Type | Article |
---|---|
Acceptance Date | Jul 28, 2016 |
Online Publication Date | Aug 5, 2016 |
Publication Date | Aug 5, 2016 |
Deposit Date | Dec 15, 2016 |
Publicly Available Date | Dec 16, 2016 |
Journal | BMC Psychiatry |
Publisher | BMC |
Peer Reviewed | Peer Reviewed |
Volume | 16 |
Issue | 280 |
DOI | https://doi.org/10.1186/s12888-016-0983-6 |
Keywords | Schizophrenia, psychosis, Clozapine-resistant, cognitive behavioural therapy, randomised controlled trial, |
Public URL | http://researchrepository.napier.ac.uk/Output/454702 |
Contract Date | Dec 16, 2016 |
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Design and protocol for the Focusing on Clozapine
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Publisher Licence URL
http://creativecommons.org/licenses/by/4.0/
Copyright Statement
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated
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