Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study
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 e...
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2024-11-01
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| Online Access: | https://doi.org/10.1186/s12888-024-06215-y |
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| author | Olena Said Dominic Stringer Ece Sengun Filiz Hiba Mutwalli Sevgi Bektas Melahat Nur Akkese Vanessa Kellermann Katie Ireland Elizabeth Tyrrell-Bunge Demelza Beishon-Murley Joel W. T. Khor Lee Allman Joanna Barker Nicus Kotze Ben Carter Mima Simic Dilveer Singh Sually Jessica Bentley Allan H. Young Sloane Madden Sarah Byford Sabine Landau Vanessa Lawrence Janet Treasure Ulrike Schmidt Dasha Nicholls Hubertus Himmerich |
| author_facet | Olena Said Dominic Stringer Ece Sengun Filiz Hiba Mutwalli Sevgi Bektas Melahat Nur Akkese Vanessa Kellermann Katie Ireland Elizabeth Tyrrell-Bunge Demelza Beishon-Murley Joel W. T. Khor Lee Allman Joanna Barker Nicus Kotze Ben Carter Mima Simic Dilveer Singh Sually Jessica Bentley Allan H. Young Sloane Madden Sarah Byford Sabine Landau Vanessa Lawrence Janet Treasure Ulrike Schmidt Dasha Nicholls Hubertus Himmerich |
| author_sort | Olena Said |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a14830d04aa54346b5089f6fe0fd8181 |
| institution | Kabale University |
| issn | 1471-244X |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj-art-a14830d04aa54346b5089f6fe0fd81812025-02-02T12:36:06ZengBMCBMC Psychiatry1471-244X2024-11-0124111110.1186/s12888-024-06215-yOlanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility studyOlena Said0Dominic Stringer1Ece Sengun Filiz2Hiba Mutwalli3Sevgi Bektas4Melahat Nur Akkese5Vanessa Kellermann6Katie Ireland7Elizabeth Tyrrell-Bunge8Demelza Beishon-Murley9Joel W. T. Khor10Lee Allman11Joanna Barker12Nicus Kotze13Ben Carter14Mima Simic15Dilveer Singh Sually16Jessica Bentley17Allan H. Young18Sloane Madden19Sarah Byford20Sabine Landau21Vanessa Lawrence22Janet Treasure23Ulrike Schmidt24Dasha Nicholls25Hubertus Himmerich26Centre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonKing’s Clinical Trials Unit, King’s College LondonDivision of Psychiatry, Department of Brain Sciences, Imperial College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonDepartment of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonSouth London and Maudsley NHS Foundation TrustSouth London and Maudsley NHS Foundation TrustSouth West London and St George’s Mental Health NHS TrustSouth West London and St George’s Mental Health NHS TrustSussex Partnership NHS Foundation TrustSolent NHS TrustDorset Healthcare University NHS Foundation TrustKing’s Clinical Trials Unit, King’s College LondonSouth London and Maudsley NHS Foundation TrustCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonUniversity of SydneyDepartment of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonKing’s Clinical Trials Unit, King’s College LondonDepartment of Health Service and Population Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonDivision of Psychiatry, Department of Brain Sciences, Imperial College LondonCentre for Research in Eating and Weight Disorders (CREW), Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King’s College LondonAbstract 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.https://doi.org/10.1186/s12888-024-06215-yAnorexia nervosaOlanzapineFeasibilityRecruitmentAdherenceAttrition |
| spellingShingle | Olena Said Dominic Stringer Ece Sengun Filiz Hiba Mutwalli Sevgi Bektas Melahat Nur Akkese Vanessa Kellermann Katie Ireland Elizabeth Tyrrell-Bunge Demelza Beishon-Murley Joel W. T. Khor Lee Allman Joanna Barker Nicus Kotze Ben Carter Mima Simic Dilveer Singh Sually Jessica Bentley Allan H. Young Sloane Madden Sarah Byford Sabine Landau Vanessa Lawrence Janet Treasure Ulrike Schmidt Dasha Nicholls Hubertus Himmerich Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study BMC Psychiatry Anorexia nervosa Olanzapine Feasibility Recruitment Adherence Attrition |
| title | Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study |
| title_full | Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study |
| title_fullStr | Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study |
| title_full_unstemmed | Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study |
| title_short | Olanzapine for young PEople with aNorexia nervosa (OPEN): results of a feasibility study |
| title_sort | olanzapine for young people with anorexia nervosa open results of a feasibility study |
| topic | Anorexia nervosa Olanzapine Feasibility Recruitment Adherence Attrition |
| url | https://doi.org/10.1186/s12888-024-06215-y |
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