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

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Title: Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open‐label feasibility study.
Authors: Said, Olena (AUTHOR), Sengun Filiz, Ece (AUTHOR), Stringer, Dominic (AUTHOR), Applewhite, Briana (AUTHOR), Kellermann, Vanessa (AUTHOR), Mutwalli, Hiba (AUTHOR), Bektas, Sevgi (AUTHOR), Akkese, Melahat Nur (AUTHOR), Kumar, Ashish (AUTHOR), Carter, Ben (AUTHOR), Simic, Mima (AUTHOR), Sually, Dilveer (AUTHOR), Bentley, Jessica (AUTHOR), Young, Allan H. (AUTHOR), Madden, Sloane (AUTHOR), Byford, Sarah (AUTHOR), Landau, Sabine (AUTHOR), Lawrence, Vanessa (AUTHOR), Treasure, Janet (AUTHOR), Schmidt, Ulrike (AUTHOR)
Source: European Eating Disorders Review. May2024, Vol. 32 Issue 3, p532-546. 15p.
Subjects: Patient safety, Olanzapine, Pilot projects, Anorexia nervosa, Drug efficacy, Evaluation, Adolescence, Adults
Abstract: 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. Highlights: There is a lack of evidence for the use of pharmacological treatment in anorexia nervosa (AN).The Olanzapine for young PEople with aNorexia nervosa study will assess the feasibility of exploring the safety and efficacy of olanzapine in adolescents and young adults with AN.The study will inform a future randomised controlled trial on the efficacy and safety of prescribing olanzapine for AN. [ABSTRACT FROM AUTHOR]
Copyright of European Eating Disorders Review is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open‐label feasibility study.
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  Data: <searchLink fieldCode="JN" term="%22European+Eating+Disorders+Review%22">European Eating Disorders Review</searchLink>. May2024, Vol. 32 Issue 3, p532-546. 15p.
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  Data: <searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink><br /><searchLink fieldCode="DE" term="%22Olanzapine%22">Olanzapine</searchLink><br /><searchLink fieldCode="DE" term="%22Pilot+projects%22">Pilot projects</searchLink><br /><searchLink fieldCode="DE" term="%22Anorexia+nervosa%22">Anorexia nervosa</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+efficacy%22">Drug efficacy</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation%22">Evaluation</searchLink><br /><searchLink fieldCode="DE" term="%22Adolescence%22">Adolescence</searchLink><br /><searchLink fieldCode="DE" term="%22Adults%22">Adults</searchLink>
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  Data: 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. Highlights: There is a lack of evidence for the use of pharmacological treatment in anorexia nervosa (AN).The Olanzapine for young PEople with aNorexia nervosa study will assess the feasibility of exploring the safety and efficacy of olanzapine in adolescents and young adults with AN.The study will inform a future randomised controlled trial on the efficacy and safety of prescribing olanzapine for AN. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of European Eating Disorders Review is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1002/erv.3060
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        Text: English
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