Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open-label feasibility study.
anorexia nervosa
feasibility
olanzapine
weight restoration
Journal
European eating disorders review : the journal of the Eating Disorders Association
ISSN: 1099-0968
Titre abrégé: Eur Eat Disord Rev
Pays: England
ID NLM: 9436977
Informations de publication
Date de publication:
01 Feb 2024
01 Feb 2024
Historique:
revised:
13
12
2023
received:
12
05
2023
accepted:
30
12
2023
medline:
1
2
2024
pubmed:
1
2
2024
entrez:
1
2
2024
Statut:
aheadofprint
Résumé
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. 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. 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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre Health Technology Assessment Programme
ID : NIHR130780
Informations de copyright
© 2024 The Authors. European Eating Disorders Review published by Eating Disorders Association and John Wiley & Sons Ltd.
Références
Arain, M., Campbell, M. J., Cooper, C. L., & Lancaster, G. A. (2010). What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Medical Research Methodology, 10(1), 1-7. https://doi.org/10.1186/1471-2288-10-67
Association of the Scientific Medical Societies in Germany. (2010). Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF. S3-guideline for the assessment and therapy of eating disorders [S3 Leitlinie Diagnostik und Therapie von Essstörungen], 051-26.
Attia, E., Kaplan, A. S., Walsh, B. T., Gershkovich, M., Yilmaz, Z., Musante, D., & Wang, Y. (2011). Olanzapine versus placebo for out-patients with anorexia nervosa. Psychological Medicine, 41(10), 2177-2182. https://doi.org/10.1017/s0033291711000390
Attia, E., Steinglass, J. E., Walsh, B. T., Wang, Y., Wu, P., Schreyer, C., Wildes, J., Yilmaz, Z., Guarda, A. S., Kaplan, A. S., & Marcus, M. D. (2019). Olanzapine versus placebo in adult outpatients with anorexia nervosa: A randomized clinical trial. American Journal of Psychiatry, 176(6), 449-456. https://doi.org/10.1176/appi.ajp.2018.18101125
Batóg, P., Rencz, F., Péntek, M., Gulácsi, L., Filipiak, K. J., Prevolnik Rupel, V., Simon, J., Brodszky, V., Baji, P., Závada, J., Petrova, G., Rotar, A., & Golicki, D. (2018). EQ-5D studies in cardiovascular diseases in eight Central and Eastern European countries: A systematic review of the literature. Kardiologia Polska, 76(5), 860-870. https://doi.org/10.5603/kp.a2018.0033
Beykloo, M., Nicholls, D., Simic, M., Brauer, R., Mills, E., & Wong, I. C. (2019). Survey on self-reported psychotropic drug prescribing practices of eating disorder psychiatrists for the treatment of young people with anorexia nervosa. BMJ Open, 9, e031707.
Birmingham, C. L., & Treasure, J. (2019). Medical management of eating disorders. Cambridge University Press.
Bissada, H., Tasca, G. A., Barber, A. M., & Bradwejn, J. (2008). Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: A randomized, double-blind, placebo-controlled trial. American Journal of Psychiatry, 165(10), 1281-1288. https://doi.org/10.1176/appi.ajp.2008.07121900
Boekaerts, M., Maes, S., & Karoly, P. (2005). Self-regulation across domains of applied psychology: Is there an emerging consensus? Applied Psychology, 54(2), 149-154. https://doi.org/10.1111/j.1464-0597.2005.00201.x
Borges, K., Lewis, Y. D., Bentley, J., & Himmerich, H. (2020). Use of antipsychotics in the treatment of eating disorders BT - NeuroPsychopharmacotherapy (P. Riederer, G. Laux, T. Nagatsu, W. Le, & C. Riederer, Eds., pp. 1-14). Springer International Publishing.
Brambilla, F., Garcia, C. S., Fassino, S., Daga, G. A., Favaro, A., Santonastaso, P., Ramaciotti, C., Bondi, E., Mellado, C., Borriello, R., & Monteleone, P. (2007). Olanzapine therapy in anorexia nervosa: Psychobiological effects. International Clinical Psychopharmacology, 22(4), 197-204. https://doi.org/10.1097/yic.0b013e328080ca31
Brown, T. A., Chorpita, B. F., Korotitsch, W., & Barlow, D. H. (1997). Psychometric properties of the Depression Anxiety Stress Scales (DASS) in clinical samples. Behaviour Research and Therapy, 35(1), 79-89. https://doi.org/10.1016/s0005-7967(96)00068-x
Bulik-Sullivan, B., Finucane, H. K., Anttila, V., Gusev, A., Day, F. R., & Loh, P. R. (2015). ReproGen Consortium; Psychiatric Genomics Consortium; Genetic Consortium for Anorexia Nervosa of the Wellcome Trust Case Control Consortium, Duncan L, Perry JR, Patterson N, Robinson EB, Daly MJ, Price AL, Neale BM. An atlas of genetic correlations across human diseases and traits. Nature Genetics, 47(11), 1236-1241. https://doi.org/10.1038/ng.3406
Byford, S. (2013). The validity and responsiveness of the EQ-5D measure of health-related quality of life in an adolescent population with persistent major depression. Journal of Mental Health, 22(2), 101-110. https://doi.org/10.3109/09638237.2013.779366
Chandwick, P., Lees, S., & Birchwood, M. (2000). The revised Beliefs About Voices Questionnaire (BAVQ-R). British Journal of Psychiatry, 177(3), 229-232. https://doi.org/10.1192/bjp.177.3.229
Chorpita, B. F., Moffitt, C. E., & Gray, J. (2005). Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behaviour Research and Therapy, 43(3), 309-322. https://doi.org/10.1016/j.brat.2004.02.004
Costa, D. L. C., Diniz, J. B., Requena, G., Joaquim, M. A., Pittenger, C., Bloch, M. H., Miguel, E. C., & Shavitt, R. G. (2017). Randomized, double-blind, placebo-controlled trial of N-acetylcysteine augmentation for treatment-Resistant obsessive-compulsive disorder. The Journal of Clinical Psychiatry, 78(7), 766-773. https://doi.org/10.4088/jcp.16m11101
Dessain, A., Bentley, J., Treasure, J., Schmidt, U., & Himmerich, H. (2019). Patients’ and carers’ perspectives of psychopharmacological interventions targeting anorexia nervosa symptoms. In H. Himmerich (Ed.), Jáuregui Lobera I (Hrg.): Anorexia and bulimia nervosa. InTech Open.
Dutch Foundation for Quality Development in Mental Healthcare. (2017). Practice guideline for the treatment of eating disorders [Zorgstandaard Eetstoornissen]. Netwerk Kwaliteitsontwikkeling GGz.
Eddy, K. T., Tabri, N., Thomas, J. J., Murray, H. B., Keshaviah, A., Hastings, E., Edkins, K., Krishna, M., Herzog, D. B., Keel, P. K., & Franko, D. L. (2017). Recovery from anorexia nervosa and bulimia nervosa at 22-year follow-up. The Journal of Clinical Psychiatry, 78(02), 184-189. https://doi.org/10.4088/jcp.15m10393
Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., & Lancaster, G. A. (2016). CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. BMJ, 355.
Goodman, W. K., Price, L. H., Rasmussen, S. A., Mazure, C., Fleischmann, R. L., Hill, C. L., Heninger, G. R., & Charney, D. S. (1989). The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Archives of General Psychiatry, 46, 1006-1011. https://doi.org/10.1001/archpsyc.1989.01810110048007
Han, R., Bian, Q., & Chen, H. (2022). Effectiveness of olanzapine in the treatment of anorexia nervosa: A systematic review and meta-analysis. Brain Behav, 12(2), e2498. https://doi.org/10.1002/brb3.2498
Hasan, A., Falkai, P., Wobrock, T., Lieberman, J., Glenthoj, B., Gattaz, W. F., Thibaut, F., & Möller, H. J. (2013). WFSBP Task force on Treatment Guidelines for Schizophrenia. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: Update 2012 on the long-term treatment of schizophrenia and management of antipsychotic-induced side effects. World Journal of Biological Psychiatry, 14(1), 2-44. https://doi.org/10.3109/15622975.2012.739708
Hay, P., Chinn, D., Forbes, D., Madden, S., Newton, R., Sugenor, L., Touyz, S., & Ward, W. (2014). Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of eating disorders. Australian and New Zealand Journal of Psychiatry, 48(11), 977-1008. https://doi.org/10.1177/0004867414555814
Hiemke, C., Baumann, P., Bergemann, N., Conca, A., Dietmaier, O., Egberts, K., Fric, M., Gerlach, M., Greiner, C., Gründer, G., Haen, E., Havemann-Reinecke, U., Jaquenoud Sirot, E., Kirchherr, H., Laux, G., Lutz, U. C., Messer, T., Müller, M. J., Pfuhlmann, B, … Zernig, G. (2011). AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: Update 2011. Pharmacopsychiatry, 44(06), 195-235. https://doi.org/10.1055/s-0031-1286287
Hiemke, C., Bergemann, N., Clement, H., Conca, A., Deckert, J., Domschke, K., Eckermann, G., Egberts, K., Gerlach, M., Greiner, C., Gründer, G., Haen, E., Havemann-Reinecke, U., Hefner, G., Helmer, R., Janssen, G., Jaquenoud, E., Laux, G., Messer, T., … Baumann, P. (2018). Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry, 51(1-02), 9-62. https://doi.org/10.1055/s-0043-116492
Himmerich, H., Lewis, Y. D., Conti, C., Mutwalli, H., Karwautz, A., Sjögren, J. M., Uribe Isaza, M. M., Tyszkiewicz-Nwafor, M., Aigner, M., McElroy, S. L., Treasure, J., Kasper, S., Bailer, U., Bulik, C. M., Zwaan, M. D., Favaro, A., Fernandez-Aranda, F., Fetissov, S., … Yoshiuchi, K. (2023). World Federation of Societies of Biological Psychiatry (WFSBP) guidelines update 2023 on the pharmacological treatment of eating disorders. World Journal of Biological Psychiatry, 24(8), 1-64. https://doi.org/10.1080/15622975.2023.2179663
Himmerich, H., Minkwitz, J., & Kirkby, K. C. (2015). Weight gain and metabolic changes during treatment with antipsychotics and antidepressants. Endocrine, Metabolic & Immune Disorders: Drug Targets, 15(4), 252-260. https://doi.org/10.2174/1871530315666150623092031
Johns, M. W. (1991). A new method for measuring daytime sleepiness: The Epworth sleepiness scale. Sleep, 14(6), 540-545. https://doi.org/10.1093/sleep/14.6.540
Kafantaris, V., Leigh, E., Hertz, S., Berest, A., Schebendach, J., Sterling, W. M., Saito, E., Sunday, S., Higdon, C., Golden, N. H., & Malhotra, A. K. (2011). A placebo-controlled pilot study of adjunctive olanzapine for adolescents with anorexia nervosa. Journal of Child and Adolescent Psychopharmacology, 21(3), 207-212. https://doi.org/10.1089/cap.2010.0139
Karwautz, A., Zeiler, M., Schwarzenberg, J., Mairhofer, D., Mitterer, M., Truttmann, S., Philipp, J., Koubek, D., Glüder, M., Wagner, G., Malcher, A., Schöfbeck, G., Laczkovics, C., Rock, H. W., Zanko, A., Imgart, H., Banaschewski, T., Fleischhaker, C., Correll, C. U., … Gerlach, M. (2023). Therapeutic drug monitoring in adolescents with anorexia nervosa for safe treatment with adjunct olanzapine. European Eating Disorders Review, 1-14. https://doi.org/10.1002/erv.3022
Keski-Rahkonen, A., & Mustelin, L. (2016). Epidemiology of eating disorders in Europe: Prevalence, incidence, comorbidity, course, consequences, and risk factors. Current Opinion in Psychiatry, 29(6), 340-345. https://doi.org/10.1097/yco.0000000000000278
Kliemann, N., Beeken, R. J., Wardle, J., & Johnson, F. (2016). Development and validation of the Self-Regulation of Eating Behaviour Questionnaire for adults. International Journal of Behavioral Nutrition and Physical Activity, 13(1), 1-11. https://doi.org/10.1186/s12966-016-0414-6
Kluge, M., Schacht, A., Himmerich, H., Rummel-Kluge, C., Wehmeier, P. M., Dalal, M., Hinze-Selch, D., Kraus, T., Dittmann, R. W., Pollmächer, T., & Schuld, A. (2014). Olanzapine and clozapine differently affect sleep in patients with schizophrenia: Results from a double-blind, polysomnographic study and review of the literature. Schizophrenia Research, 152(1), 255-260. https://doi.org/10.1016/j.schres.2013.11.009
Kuyken, W., Hayes, R., Barrett, B., Byng, R., Dalgleish, T., Kessler, D., Lewis, G., Watkins, E., Brejcha, C., Cardy, J., Causley, A., Cowderoy, S., Evans, A., Gradinger, F., Kaur, S., Lanham, P., Morant, N., Richards, J., Shah, P, … Byford, S. (2015). Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): A randomised controlled trial. Lancet, 386(9988), 63-73. Epub 2015 Apr 20. Erratum for: Lancet. 2016 Oct 1;388(10052):1376. PMID: 25907157. https://doi.org/10.1016/S0140-6736(14)62222-4
Lam, W. Y., & Fresco, P. (2015). Medication adherence measures: An overview. BioMed Research International, 2015, 217047. https://doi.org/10.1155/2015/217047
Lauer, C. J., & Krieg, J. C. (2004). Sleep in eating disorders. Sleep Medicine Reviews, 8(2), 109-118. https://doi.org/10.1016/s1087-0792(02)00122-3
Lingjaerde, O., Ahlfors, U. G., Bech, P., Dencker, S. J., & Elgen, K. (1987). The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychatr Scand, 76(Suppl 334), 1-100. https://doi.org/10.1111/j.1600-0447.1987.tb10566.x
Luce, K. H., & Crowther, J. H. (1999). The reliability of the Eating Disorder Examination-Self-Report Questionnaire Version (EDE-Q). International Journal of Eating Disorders, 25(3), 349-351. https://doi.org/10.1002/(sici)1098-108x(199904)25:3<349::aid-eat15>3.3.co;2-d
Malterud, K., Siersma, V. D., & Guassora, A. D. (2016). Sample size in qualitative interview studies: Guided by information power. Qualitative Health Research, 26(13), 1753-1760. https://doi.org/10.1177/1049732315617444
Mutwalli, H., Lewis, Y. D., Conti, C., Treasure, J., & Himmerich, H. (2023). Pharmacological treatment and eating disorders BT - Eating disorders: An international comprehensive view (P. Robinson, T. Wade, B. Herpertz-Dahlmann, F. Fernandez-Aranda, J. Treasure, & S. Wonderlich, Eds., pp. 1-22). Springer International Publishing. https://doi.org/10.1007/978-3-030-97416-9_72-1
National Institute for Health and Care Excellence. (2017). Eating disorders: Recognition and treatment. Published May 2017, updated December 2020. (Clinical guideline [NG69]). NICE. Retrieved July 4, 2022, from https://www.nice.org.uk/guidance/ng69
Posner, K., Brown, G. K., Stanley, B., Brent, D. A., Yershova, K. V., Oquendo, M. A., Currier, G. W., Melvin, G. A., Greenhill, L., Shen, S., & Mann, J. J. (2011). The Columbia-Suicide Severity Rating Scale: Initial validity and internal consistency findings from three multisite studies with adolescents and adults. American Journal of Psychiatry, 168(12), 1266-1277. https://doi.org/10.1176/appi.ajp.2011.10111704
Pugh, M., & Waller, G. (2017). Understanding the ‘Anorexic Voice’ in anorexia nervosa. Clinical Psychology & Psychotherapy, 24(3), 670-676. https://doi.org/10.1002/cpp.2034
Ritchie, J., & Spencer, L. (1994). Qualitative data analysis for applied policy research. In A. Bryman & R. G. Burgess (Eds.), Analyzing qualitative data. Routledge.
Royal College of Psychiatrists. (2022). Quality network for eating disorders (QED) quality standards for adult community eating disorder services [Internet]. (CCQI 393). RCPsych. Retrieved September 14, 2022, from https://www.rcpsych.ac.uk/docs/default-source/improving-care/ccqi/quality-networks/eating-disorders-qed/qed-community-standards---third-edition.pdf?sfvrsn=e8b3aebc_4
Schmidt, U., Adan, R., Böhm, I., Campbell, I. C., Dingemans, A., Ehrlich, S., Elzakkers, I., Favaro, A., Giel, K., Harrison, A., Himmerich, H., Hoek, H. W., Herpertz-Dahlmann, B., Kas, M. J., Seitz, J., Smeets, P., Sternheim, L., Tenconi, E., van Elburg, A., van Furth, E., & Zipfel, S. (2016). Eating disorders: The big issue. The Lancet Psychiatry, 3(4), 313-315. https://doi.org/10.1016/s2215-0366(16)00081-x
Sepulveda, A. R., Whitney, J., Hankins, M., & Treasure, J. (2008). Development and validation of an Eating Disorders Symptom Impact Scale (EDSIS) for carers of people with eating disorders. Health and Quality of Life Outcomes, 6(1), 28. https://doi.org/10.1186/1477-7525-6-28
Sim, J., & Lewis, M. (2012). The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. Journal of Clinical Epidemiology, 65(3), 301-308. https://doi.org/10.1016/j.jclinepi.2011.07.011
Solmi, M., Radua, J., Olivola, M., Croce, E., Soardo, L., Salazar de Pablo, G., Il Shin, J., Kirkbride, J. B., Jones, P., Kim, J. H., Kim, J. Y., Carvalho, A. F., Seeman, M. V., Correll, C. U., & Fusar-Poli, P. (2022). Age at onset of mental disorders worldwide: Large-scale meta-analysis of 192 epidemiological studies. Molecular Psychiatry, 27(1), 281-295. https://doi.org/10.1038/s41380-021-01161-7
Tan, E. J., Raut, T., Le, L. K.-D., Hay, P., Ananthapavan, J., Lee, Y. Y., & Mihalopoulos, C. (2023). The association between eating disorders and mental health: An umbrella review. Journal of Eating Disorders, 11(1), 51. https://doi.org/10.1186/s40337-022-00725-4
Tek, C., Kucukgoncu, S., Guloksuz, S., Woods, S. W., Srihari, V. H., & Annamalai, A. (2016). Antipsychotic-induced weight gain in first-episode psychosis patients: A meta-analysis of differential effects of antipsychotic medications. Early Intervention in Psychiatry, 10(3), 193-202. https://doi.org/10.1111/eip.12251
Temmingh, H., & Stein, D. J. (2015). Anxiety in patients with schizophrenia: Epidemiology and management. CNS Drugs, 29(10), 819-832. https://doi.org/10.1007/s40263-015-0282-7
Treasure, J. (2004). A guide to the medical risk assessment for eating disorders. King’s College London, Section of Eating Disorders, Institute of Psychiatry. Retrieved July 5, 2022, from http://www.iop.kcl.ac.uk/sites/edu. Accessed 05 July 2022.
van Duijn, E., Vrijmoeth, E. M., Giltay, E. J., & Bernhard Landwehrmeyer, G. (2017). REGISTRY investigators of the European Huntington's Disease Network. Suicidal ideation and suicidal behavior according to the C-SSRS in a European cohort of Huntington's disease gene expansion carriers. Journal of Affective Disorders, 228, 194-204.
Wille, N., Badia, X., Bonsel, G., Burström, K., Cavrini, G., Devlin, N., Egmar, A. C., Greiner, W., Gusi, N., Herdman, M., Jelsma, J., Kind, P., Scalone, L., & Ravens-Sieberer, U. (2010). Development of the EQ-5D-Y: A child-friendly version of the EQ-5D. Quality of Life Research, 19(6), 875-886. https://doi.org/10.1007/s11136-010-9648-y
Wolfe, K. L., Nakonezny, P. A., Owen, V. J., Rial, K. V., Moorehead, A. P., Kennard, B. D., & Emslie, G. J. (2019). Hopelessness as a predictor of suicide ideation in depressed male and female adolescent youth. Suicide and Life-Threatening Behavior, 49(1), 253-263. https://doi.org/10.1111/sltb.12428