Design and protocol for the Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial: a randomised controlled trial

BMC Psychiatry

Study Protocol

Douglas Turkington¹  John Norrie²  Graeme MacLennan²  Thomas R. E. Barnes³  Matthias Schwannauer⁴  Helen Griffiths⁴  Paul Hutton⁴  Linda Davies⁵  Andrew Gumley⁶  Hamish J. McLeod⁶  Suzy Syrett⁶  Robert Dudley⁷  Samantha Bowe⁸  Rory Byrne⁹  Anthony P. Morrison⁹  Melissa Pyle⁹  Paul French^1,10  David Kingdon^1,11 

[1] Academic Psychiatry, Northumberland, Tyne and Wear NHS Foundation Trust, Centre for Aging and Vitality, Newcastle General Hospital, Westgate Road, NE4 6BE, Newcastle upon Tyne, UK;Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, 3rd Floor Health Sciences Building, AB25 2ZD, Aberdeen, UK;Centre for Mental Health, Imperial College London, Charing Cross Campus, St Dunstans Road, W6 8RP, London, UK;Department of Clinical Psychology, University of Edinburgh. Medical School, Teviot Place, EHY8 9AG, Edinburgh, UK;Department of Psychology, University of Manchester, Zochonis Building, M13 9PL, Manchester, UK;Institute of Health and Wellbeing, University of Glasgow, Gartnavel Royal Hospital, 1055 Great Western Road, G12 0XH, Glasgow, UK;School of Psychology, Newcastle University, 4th Floor, Ridley Building 1, Queen Victoria Road, NE1 7RU, Newcastle Upon Tyne, UK;The Psychosis Research Unit, Department of Psychology, Greater Manchester West Mental Health NHS Foundation Trust, M25 3BL, Prestwich, UK;The Psychosis Research Unit, Department of Psychology, Greater Manchester West Mental Health NHS Foundation Trust, M25 3BL, Prestwich, UK;Department of Psychology, University of Manchester, Zochonis Building, M13 9PL, Manchester, UK;The Psychosis Research Unit, Department of Psychology, Greater Manchester West Mental Health NHS Foundation Trust, M25 3BL, Prestwich, UK;Institute of Psychology, Health and Society, University of Liverpool, Waterhouse Building, Block B, 2nd Floor, L69 3BX, Liverpool, UK;University Department of Psychiatry, University of Southampton, Academic Centre, College Keep 4 - 12 Terminus Terrace, SO14 3DT, Southampton, UK;

关键词: Schizophrenia;    Psychosis;    Clozapine-resistant;    Cognitive behavioural therapy;    Randomised controlled trial;   

DOI  :  10.1186/s12888-016-0983-6

 received in 2016-07-18, accepted in 2016-07-28,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundFor 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/designA 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.DiscussionThe 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 registrationCurrent Controlled Trials ISRCTN99672552. Registered 29th November 2012.

【 授权许可】

CC BY   
© The Author(s). 2016