OPEN
Research type
Research Study
Full title
Olanzapine for young PEople with aNorexia nervosa: An open-label feasibility study to test recruitment, treatment acceptance, adherence, safety, and outcome measures assessment and patients' experience to prepare for a definitive randomised placebo-controlled trial
IRAS ID
295297
Contact name
Hubertus Himmerich
Contact email
Sponsor organisation
King's College London
Eudract number
2021-004598-30
ISRCTN Number
ISRCTN80075010
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
The present treatments for anorexia are not really helping severely ill people with anorexia. Many doctors prescribe medications that are not approved for treating anorexia; however, it is unclear whether these drugs are safe or help at all.
We talked to patients, their families and leading experts about their views on drugs that could help with anorexia and have evaluated what has been written on the subject by experts. Olanzapine appears to be a helpful and safe medication; it may help with anorexic thoughts, low mood, sleep and anxieties, which are considered important factors for patients. Olanzapine has also been shown to help increase weight gain; however, further evidence is required. It is not currently approved for anorexia.
We gathered a team with strong expertise in anorexia and mental health medicines. The team includes patients with lived experience of anorexia. A twin study will be conducted by the University of Sydney (Australia). The data from both studies will be input in a shared database. Nine NHS Trusts and two Australian eating disorder services will be used as treatment centres.We are planning to perform a preliminary study with 55 female or male patients with anorexia in the UK who are aged 12–24 years, can safely take olanzapine and have not gained sufficient weight under specialist treatment. We recommend patients take olanzapine for a 12-month period in the study.
We will determine how many patients need to be asked to recruit, who will agree to take part, receive olanzapine as a normal prescription alongside their usual treatment, and assess whether olanzapine has helped them. In addition to questionnaires, physical examinations and laboratory investigations are planned. A researcher will have in-depth talks with the study participants to find out about their experience, why they agreed/did not agree to olanzapine, and why they took it for 12 months or stopped. Patients will be examined after 8 and 16 weeks, after 6 months and after 12 months. At each time point, doctors will review the treatment together with the patients and make a decision on whether to continue with olanzapine. After this preliminary study, we will be able to determine whether the methods we intend to use to measure outcomes work. Once we have the above information, we can prepare a larger study with >300 participants. This number will be necessary to draw firm conclusions. Our findings will be published in journals in cooperation with patients with anorexia, and presented at patients’ and carers’ meetings, and scientific conferences. Interested participants will be kept up-to-date with the study progress. Before applying for this larger study, we will discuss the full research plan with patients, carers and experts.REC name
HSC REC B
REC reference
22/NI/0010
Date of REC Opinion
10 Mar 2022
REC opinion
Further Information Favourable Opinion