TY - JOUR
T1 - Olanzapine for young people with anorexia nervosa
T2 - a synopsis of the main results from the OPEN open-label feasibility study
AU - Filiz, Ece Sengun
AU - Stringer, Dominic
AU - Kellermann, Vanessa
AU - Olive, Rachel
AU - Said, Olena
AU - Mutwalli, Hiba
AU - Bektas, Sevgi
AU - Akkese, Melahat Nur
AU - Ireland, Katie
AU - Beishon-Murley, Demelza
AU - Khor, Joel W T
AU - Allman, Lee
AU - Kotze, Nicus
AU - Carter, Ben
AU - Tyrrell-Bunge, Elizabeth
AU - Rowlands, Katie
AU - Keeler, Johanna
AU - Ivin, Glynis
AU - Simic, Mima
AU - Sually, Dilveer
AU - Bentley, Jessica
AU - Young, Allan
AU - Madden, Sloane
AU - Byford, Sarah
AU - Landau, Sabine
AU - Treasure, Janet
AU - Schmidt, Ulrike
AU - Nicholls, Dasha
AU - Lawrence, Vanessa
AU - Himmerich, Hubertus
N1 - Publisher Copyright:
© 2026 Filiz et al.
PY - 2026/5/31
Y1 - 2026/5/31
N2 - Background: In clinical practice, olanzapine is commonly used in young people with anorexia nervosa, although the underpinning evidence-base is limited. However, its efficacy, tolerability, acceptability and adherence rate, and the patients', carers' and clinicians' views of olanzapine treatment are unclear. This synopsis article summarises the methods and results of the OPEN feasibility study, overarching the findings and drawing comprehensive conclusions from a quantitative feasibility outcome paper and two qualitative research papers. Methods: The OPEN study assessed the feasibility of a future randomised controlled trial on olanzapine in young people with anorexia nervosa in an open-label, one-armed feasibility study. In this study, we aimed to include 55 patients with anorexia nervosa or atypical anorexia nervosa aged 12-24 who gained < 2 kg within at least 1 month of treatment as usual. Time points for assessments were at baseline, 8 weeks, 16 weeks, and 6 or 12 months. We estimated recruitment, adherence and attrition rates and mean changes in body weight, body mass index and eating disorder psychopathology. In addition, we explored the views on and experiences with olanzapine treatment within a clinical trial setting using qualitative interviews with young people with anorexia nervosa, their families and clinicians. Results: Fifty-two people were pre-screened, 35 were eligible and 20 participants were recruited and started olanzapine. Of these, 15 continued olanzapine for ≥ 16 weeks. Participants experienced, on average, a decrease in their eating disorder psychopathology, and body weight and body mass index increased during treatment with olanzapine as an adjunct to treatment as usual. Important themes derived from semi-structured qualitative interviews with young people and their parents were: moving away from the illness towards recovery, evaluating information on olanzapine, consent and trust in shared decision-making and the ambivalence around recovery. The main themes expressed by clinicians included: acknowledging the concerns of young people with anorexia nervosa and their families, prioritising person-centred care, the limited service capacity and strict study eligibility criteria. Limitations: The study failed to meet the recruitment target and showed low adherence rates for treatment with olanzapine. Possible reasons for the recruitment difficulties and the low adherence rate include the high clinical workload of eating disorder services during and after the COVID-19 pandemic, the heterogeneity of eating disorder service setup across the country, and the reluctance of patients to agree to take olanzapine under the relatively restricted conditions of a clinical study. Conclusions: A realistic time schedule for site-preparation, recruitment, treatment and follow-up, realistic recruitment targets and easy access to medical and laboratory examinations may improve the success of future feasibility studies and randomised controlled trials in this patient group. Future work: The difficulties in conducting the OPEN study will inform the planning for future pharmacological and non-pharmacological studies in anorexia nervosa. Therefore, we developed a checklist with action points for the planning of pharmacological trials in eating disorders. Furthermore, novel pharmacological options such as typical and atypical psychedelic drugs (e.g. psilocybin and ketamine) might be more acceptable for people with anorexia nervosa as they do not have the side effect of immediate weight gain. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR130780.
AB - Background: In clinical practice, olanzapine is commonly used in young people with anorexia nervosa, although the underpinning evidence-base is limited. However, its efficacy, tolerability, acceptability and adherence rate, and the patients', carers' and clinicians' views of olanzapine treatment are unclear. This synopsis article summarises the methods and results of the OPEN feasibility study, overarching the findings and drawing comprehensive conclusions from a quantitative feasibility outcome paper and two qualitative research papers. Methods: The OPEN study assessed the feasibility of a future randomised controlled trial on olanzapine in young people with anorexia nervosa in an open-label, one-armed feasibility study. In this study, we aimed to include 55 patients with anorexia nervosa or atypical anorexia nervosa aged 12-24 who gained < 2 kg within at least 1 month of treatment as usual. Time points for assessments were at baseline, 8 weeks, 16 weeks, and 6 or 12 months. We estimated recruitment, adherence and attrition rates and mean changes in body weight, body mass index and eating disorder psychopathology. In addition, we explored the views on and experiences with olanzapine treatment within a clinical trial setting using qualitative interviews with young people with anorexia nervosa, their families and clinicians. Results: Fifty-two people were pre-screened, 35 were eligible and 20 participants were recruited and started olanzapine. Of these, 15 continued olanzapine for ≥ 16 weeks. Participants experienced, on average, a decrease in their eating disorder psychopathology, and body weight and body mass index increased during treatment with olanzapine as an adjunct to treatment as usual. Important themes derived from semi-structured qualitative interviews with young people and their parents were: moving away from the illness towards recovery, evaluating information on olanzapine, consent and trust in shared decision-making and the ambivalence around recovery. The main themes expressed by clinicians included: acknowledging the concerns of young people with anorexia nervosa and their families, prioritising person-centred care, the limited service capacity and strict study eligibility criteria. Limitations: The study failed to meet the recruitment target and showed low adherence rates for treatment with olanzapine. Possible reasons for the recruitment difficulties and the low adherence rate include the high clinical workload of eating disorder services during and after the COVID-19 pandemic, the heterogeneity of eating disorder service setup across the country, and the reluctance of patients to agree to take olanzapine under the relatively restricted conditions of a clinical study. Conclusions: A realistic time schedule for site-preparation, recruitment, treatment and follow-up, realistic recruitment targets and easy access to medical and laboratory examinations may improve the success of future feasibility studies and randomised controlled trials in this patient group. Future work: The difficulties in conducting the OPEN study will inform the planning for future pharmacological and non-pharmacological studies in anorexia nervosa. Therefore, we developed a checklist with action points for the planning of pharmacological trials in eating disorders. Furthermore, novel pharmacological options such as typical and atypical psychedelic drugs (e.g. psilocybin and ketamine) might be more acceptable for people with anorexia nervosa as they do not have the side effect of immediate weight gain. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR130780.
UR - https://www.scopus.com/pages/publications/105038484896
U2 - 10.3310/GJHH0812
DO - 10.3310/GJHH0812
M3 - Article
SN - 1366-5278
VL - 30
SP - 1
EP - 17
JO - Health Technology Assessment
JF - Health Technology Assessment
IS - 36
ER -