Olanzapine for young PEople with aNorexia nervosa (OPEN) : A protocol for an open-label feasibility study

© 2024 The Authors. European Eating Disorders Review published by Eating Disorders Association and John Wiley & Sons Ltd..

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.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:32

Enthalten in:

European eating disorders review : the journal of the Eating Disorders Association - 32(2024), 3 vom: 02. Apr., Seite 532-546

Sprache:

Englisch

Beteiligte Personen:

Said, Olena [VerfasserIn]
Sengun Filiz, Ece [VerfasserIn]
Stringer, Dominic [VerfasserIn]
Applewhite, Briana [VerfasserIn]
Kellermann, Vanessa [VerfasserIn]
Mutwalli, Hiba [VerfasserIn]
Bektas, Sevgi [VerfasserIn]
Akkese, Melahat Nur [VerfasserIn]
Kumar, Ashish [VerfasserIn]
Carter, Ben [VerfasserIn]
Simic, Mima [VerfasserIn]
Sually, Dilveer [VerfasserIn]
Bentley, Jessica [VerfasserIn]
Young, Allan H [VerfasserIn]
Madden, Sloane [VerfasserIn]
Byford, Sarah [VerfasserIn]
Landau, Sabine [VerfasserIn]
Lawrence, Vanessa [VerfasserIn]
Treasure, Janet [VerfasserIn]
Schmidt, Ulrike [VerfasserIn]
Nicholls, Dasha [VerfasserIn]
Himmerich, Hubertus [VerfasserIn]

Links:

Volltext

Themen:

Anorexia nervosa
Clinical Trial Protocol
Feasibility
Journal Article
N7U69T4SZR
Olanzapine
Weight restoration

Anmerkungen:

Date Completed 05.04.2024

Date Revised 05.04.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1002/erv.3060

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM36789162X