Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open-label feasibility study
Antipsychotics are routinely prescribed off-label for anorexia nervosa (AN) despite limited evidence. Olanzapine for young PEople with aNorexia nervosa (OPEN) will assess the feasibility of a future definitive trial on olanzapine in young people with AN.
Fifty-five 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. Primary feasibility parameters will be proportions of patients who agree to take olanzapine and who adhere to treatment and complete study assessments.
Qualitative interviews will examine the acceptability of the intervention and study design, both in principle and in practice, from the perspective of young people with AN, family members and healthcare professionals across treatment settings.
We will invite young people with AN who either decline or agree to participate in OPEN study to take part in a qualitative interview. The data will provide insight into the barriers of inclusion to the study, the ways in which trial procedures could be improved to optimise recruitment and retention, and the value and expectations that patients, families and healthcare professionals place on olanzapine as a treatment for AN.
This study is funded by a NIHR Health Technology Assessment Grant.