Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study

Olena Said¹, Dominic Stringer^{2

3}, Ece Sengun Filiz⁴, Hiba Mutwalli^{1

5}, Sevgi Bektas^{1

6}, Melahat Nur Akkese¹, Vanessa Kellermann⁷, Katie Ireland⁸, Elizabeth Tyrrell-Bunge⁸, Demelza Beishon-Murley⁹, Joel W T Khor⁹, Lee Allman¹⁰, Joanna Barker¹¹, Nicus Kotze¹², Ben Carter^{2

3}, Mima Simic⁸, Dilveer Singh Sually¹, Jessica Bentley¹, Allan H Young^{1

8}, Sloane Madden¹³, Sarah Byford⁷, Sabine Landau^{2

3}, Vanessa Lawrence⁷, Janet Treasure^{1

8}, Ulrike Schmidt^{1

8}, Dasha Nicholls⁴, Hubertus Himmerich^{14

15}

Affiliations

¹ Centre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AD, UK.
² King's Clinical Trials Unit, King's College London, London, UK.
³ Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
⁴ Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.
⁵ Department of Clinical Nutrition, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, 31441, Saudi Arabia.
⁶ Department of Psychology, Hacettepe University, Ankara, 06800, Turkey.
⁷ Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
⁸ South London and Maudsley NHS Foundation Trust, London, UK.
⁹ South West London and St George's Mental Health NHS Trust, London, UK.
¹⁰ Sussex Partnership NHS Foundation Trust, Hampshire, UK.
¹¹ Solent NHS Trust, Southampton, United Kingdom.
¹² Dorset Healthcare University NHS Foundation Trust, Poole, Dorset, UK.
¹³ University of Sydney, Sydney, Australia.
¹⁴ Centre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AD, UK. hubertus.himmerich@kcl.ac.uk.
¹⁵ South London and Maudsley NHS Foundation Trust, London, UK. hubertus.himmerich@kcl.ac.uk.

PMID: 39511522
PMCID: PMC11542358
DOI: 10.1186/s12888-024-06215-y

Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study

Olena Said et al. BMC Psychiatry. 2024.

. 2024 Nov 7;24(1):779.

doi: 10.1186/s12888-024-06215-y.

Authors

Affiliations

¹ Centre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AD, UK.
² King's Clinical Trials Unit, King's College London, London, UK.
³ Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
⁴ Division of Psychiatry, Department of Brain Sciences, Imperial College London, London, UK.
⁵ Department of Clinical Nutrition, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, 31441, Saudi Arabia.
⁶ Department of Psychology, Hacettepe University, Ankara, 06800, Turkey.
⁷ Department of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
⁸ South London and Maudsley NHS Foundation Trust, London, UK.
⁹ South West London and St George's Mental Health NHS Trust, London, UK.
¹⁰ Sussex Partnership NHS Foundation Trust, Hampshire, UK.
¹¹ Solent NHS Trust, Southampton, United Kingdom.
¹² Dorset Healthcare University NHS Foundation Trust, Poole, Dorset, UK.
¹³ University of Sydney, Sydney, Australia.
¹⁴ Centre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, SE5 8AD, UK. hubertus.himmerich@kcl.ac.uk.
¹⁵ South London and Maudsley NHS Foundation Trust, London, UK. hubertus.himmerich@kcl.ac.uk.

PMID: 39511522
PMCID: PMC11542358
DOI: 10.1186/s12888-024-06215-y

Abstract

Background: Despite the availability of evidence-based treatments for anorexia nervosa (AN), remission rates are moderate, and mortality is high. Olanzapine is used as adjunct therapy for AN in case of insufficient response to first-line treatments, even though the evidence is limited. Its effect on eating disorder (ED) psychopathology, its efficacy and tolerability, and its acceptability and adherence rate are unclear.

Methods: We assessed the feasibility of a future definitive trial on olanzapine in young people with AN in an open-label, one-armed feasibility study that aimed to include 55 patients with AN or atypical AN aged 12-24 who gained < 2 kg within at least one month of treatment as usual (TAU) during outpatient, inpatient, or day-care treatment. Time points for assessments were at baseline, 8 weeks, 16 weeks, and 6 or 12 months. We estimated the following planning parameters: Recruitment rate (number of patients who agreed to take olanzapine/number eligible), adherence rate (number adhering to treatment/number recruited) and attrition rate (number completing study assessments/number recruited). In addition, two exploratory effect size parameters were estimated: Mean change in body mass index (BMI) and mean change in ED psychopathology.

Results: Fifty-two people were pre-screened (June 2022 to May 2023; 10 study sites in England). 13 were ineligible at pre-screening . Of the 39 approached, 4 were found ineligible at screening. Of the remaining 35 eligible, 10 declined and 5 did not take part for other reasons. Thus, 20 participants were recruited and started olanzapine (recruitment rate: 20/35 = 57%). 15 out of 20 (75%) continued olanzapine for ≥ 16 weeks, and 13 participants (65%) remained in the trial until follow-up (either 6 or 12 months). Participants experienced, on average, a decrease over time in their Eating Disorder Examination Questionnaire (EDE-Q) Global scores (0.07 per week, N = 20) and an increase in BMI (0.08 kg/m² per week, N = 20) during treatment with olanzapine plus TAU.

Conclusions: Possible reasons for the recruitment difficulties and low adherence rate include the high clinical workload of ED services during the COVID-19 pandemic and the reluctance of patients to agree to take olanzapine under the relatively restricted conditions of a clinical study.

Trial registration: International standard randomised controlled trial register number: ISRCTN80075010. Registration date: 27/04/2022.

Keywords: Adherence; Anorexia nervosa; Attrition; Feasibility; Olanzapine; Recruitment; Side effects.

PubMed Disclaimer

Conflict of interest statement

HH is the Principal Investigator on “Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study,” a COMPASS Pathways-funded and -sponsored proof-of-concept study testing psilocybin in AN. AHY participated in paid lectures and advisory boards for the following companies: Allegan, AstraZeneca, Bionomics Ltd, Boehringer Ingelheim, COMPASS, Eli Lilly, Janssen, LivaNova, Lundbeck, Neurocentrx, Novartis, Sage, Servier, Sumitomo Dainippon Pharma, and Sunovion. AHY is the Principal Investigator in the Restore-Life VNS registry study funded by LivaNova; Principal Investigator on ESKETINTRD3004: ‘An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression’; Principal Investigator on ‘The Effects of Psilocybin on Cognitive Function in Healthy Participants’; Principal Investigator on ‘The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (p-TRD)’; UK Chief Investigator for Novartis MDD study MIJ821A12201. All other authors declare no competing interests.

Figures

**Fig. 2**
EDE-Q Global score over time in people who adhered to olanzapine. The graph corresponds to a mean decrease of 0.07 EDE-Q Global score (0.04, 0.09 95% CI) per week

**Fig. 3**
BMI over time in people who adhered to olanzapine. This graph corresponds to a mean increase of 0.08 kg/m² (0.06, 0.11 95% CI) per week in those who adhered to olanzapine

See this image and copyright information in PMC

References

1. Miskovic-Wheatley J, Bryant E, Ong SH, Vatter S, Le A, National Eating Disorder Research Consortium, Touyz S, Maguire S. Eating disorder outcomes: findings from a rapid review of over a decade of research. J Eat Disord. 2023;11(1):85. - PMC - PubMed
1. Gull WW. Anorexia nervosa (apepsia hysterica, anorexia hysterica) 1868. Obes Res. 1997;5(5):498–502. - PubMed
1. Himmerich H, Treasure J. Psychopharmacological advances in eating disorders. Expert Rev Clin Pharmacol. 2018;11(1):95–108. - PubMed
1. Bergner L, Himmerich H, Steinberg H. Therapy of food refusal and anorexia nervosa in German-Language psychiatry textbooks of the past 200 years. Fortschr Neurol Psychiatr. 2022. 10.1055/a-1897-2330 - PubMed
1. Brambilla F, Garcia CS, Fassino S, Daga GA, Favaro A, Santonastaso P, Ramaciotti C, Bondi E, Mellado C, Borriello R, Monteleone P. Olanzapine therapy in anorexia nervosa: psychobiological effects. Int Clin Psychopharmacol. 2007;22:197–204. - PubMed

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study

Affiliations

Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources