@article{005bdd9fbf18407cace7ae54413df1a5,
title = "Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open-label feasibility study",
abstract = "Introduction: Antipsychotics are routinely prescribed off-label for anorexia nervosa (AN) despite limited evidence. This article presents a protocol of a study aiming to assess the feasibility of a future definitive trial on olanzapine in young people with AN. Methods and analysis: In an open-label, one-armed feasibility study, 55 patients with AN or atypical AN, aged 12–24, receiving outpatient, inpatient or day-care treatment who are considered for olanzapine treatment will be recruited from NHS sites based in England. Assessments will be conducted at screening, baseline and at 8-, 16 weeks, 6- and 12 months. Primary feasibility parameters will be proportions of patients who agree to take olanzapine and who adhere to treatment and complete study assessments. Qualitative methods will be used to explore acceptability of the intervention and study design. Secondary feasibility parameters will be changes in body mass index, psychopathology, side effects, health-related quality of life, carer burden and proportion of participants who would enrol in a future randomised controlled trial. The study is funded by the National Institute for Health Research via Health Technology Assessment programme. Discussion: Olanzapine for young PEople with aNorexia nervosa will inform a future randomised controlled trial on the efficacy and safety of prescribing olanzapine in young people with AN.",
keywords = "anorexia nervosa, feasibility, olanzapine, weight restoration",
author = "Olena Said and {Sengun Filiz}, Ece and Dominic Stringer and Briana Applewhite and Vanessa Kellermann and Hiba Mutwalli and Sevgi Bektas and Akkese, {Melahat Nur} and Ashish Kumar and Ben Carter and Mima Simic and Dilveer Sually and Jessica Bentley and Young, {Allan H.} and Sloane Madden and Sarah Byford and Sabine Landau and Vanessa Lawrence and Janet Treasure and Ulrike Schmidt and Dasha Nicholls and Hubertus Himmerich",
note = "Funding Information: US, JT, SL and HH receive salary support from NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust (SLaM) and KCL. SL is also supported by the Applied Research Collaboration (ARC), South London. DN is supported by the NIHR ARC Northwest London, and the NIHR Imperial BRC. The views expressed are those of the authors and not necessarily those of the NIHR, the National Health Service (NHS), the Department of Health and Social Care, or the NHMRC. We thank the NIHR Research Design Service London for their advice on the study design. We additionally thank the members of the Data Monitoring Committee (Dr. John Roche, Dr. Charlotte Scott, Ms. Rebecca Woolley) and the Trial Steering Committee (Dr. Helen E. Bould, Prof Paul Robinson, Dr. Michael Kluge, Dr. Stephany Fulda, Ms. Jessica Bentley, Ms. Aylin Unlu) for contributing their time and valuable expertise to the oversight of the project. This study has been funded by the National Institute for Health Research (NIHR) Evaluation, Trials and Studies Coordinating Centre (NETSCC) Health Technology Assessment (HTA) Programme (project reference NIHR130780). King's College London (KCL) is the lead sponsor and South London and Maudsley NHS Foundation Trust (SLaM) is the co‐sponsor for this study. The sponsors act as data controllers. OPEN has a separate sister study planned in Australia, which aims to recruit 15 participants. The study was planned in two countries to allow for differences in healthcare systems and care processes to be explored. The study protocols are largely similar, with separate ethics approval, funding and sponsorship. The Australian part of the study was approved by the Sydney Children Hospitals Network Human Research Ethics Committee (HREC reference 2021/ETH01321) on 20 September 2021 and has been funded by the National Health and Medical Research Council (NHMRC). The sponsor is the University of Sydney. The current protocol article refers exclusively to the OPEN study performed in the UK. Publisher Copyright: {\textcopyright} 2024 The Authors. European Eating Disorders Review published by Eating Disorders Association and John Wiley & Sons Ltd.",
year = "2024",
month = may,
doi = "10.1002/erv.3060",
language = "English",
volume = "32",
pages = "532--546",
journal = "European Eating Disorders Review",
issn = "1072-4133",
number = "3",
}
