TY - JOUR
T1 - Olanzapine for young PEople with aNorexia nervosa (OPEN)
T2 - results of a feasibility study
AU - Said, Olena
AU - Stringer, Dominic
AU - Sengun Filiz, Ece
AU - Mutwalli, Hiba
AU - Bektas, Sevgi
AU - Akkese, Melahat Nur
AU - Kellermann, Vanessa
AU - Ireland, Katie
AU - Tyrrell-Bunge, Elizabeth
AU - Beishon-Murley, Demelza
AU - Khor, Joel W.T.
AU - Allman, Lee
AU - Barker, Joanna
AU - Kotze, Nicus
AU - Carter, Ben
AU - Simic, Mima
AU - Sually, Dilveer Singh
AU - Bentley, Jessica
AU - Young, Allan H.
AU - Madden, Sloane
AU - Byford, Sarah
AU - Landau, Sabine
AU - Lawrence, Vanessa
AU - Treasure, Janet
AU - Schmidt, Ulrike
AU - Nicholls, Dasha
AU - Himmerich, Hubertus
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/11/7
Y1 - 2024/11/7
N2 - 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.
AB - 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.
KW - Adherence
KW - Anorexia nervosa
KW - Attrition
KW - Feasibility
KW - Olanzapine
KW - Recruitment
KW - Side effects
UR - http://www.scopus.com/inward/record.url?scp=85208713861&partnerID=8YFLogxK
U2 - 10.1186/s12888-024-06215-y
DO - 10.1186/s12888-024-06215-y
M3 - Article
C2 - 39511522
AN - SCOPUS:85208713861
SN - 1471-244X
VL - 24
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 779
ER -