19/76 Antipsychotics for young people with anorexia nervosa
The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.
Research Question: For young people with anorexia nervosa, is it feasible to conduct a trial to examine the benefits and harms of prescribing atypical antipsychotics to those who have not responded to first-line treatments?
- Intervention: An antipsychotic plus usual care – applicants to define and justify.
- Patient group: Young people (under 25 years and including adolescents) with anorexia nervosa who have not responded adequately to recommended non-pharmacological first-line treatments – to be defined and justified by applicants. Consideration should be given to any comorbid health conditions and any additional prescription medications.
- Study design: A stand-alone feasibility study to determine whether a trial is possible and to establish key elements of the potential future trial design. This should include an investigation of the willingness to accept and adhere to the intervention and a demonstration that adherence can be measured.
- Important outcomes and outputs: Evidence of willingness to accept and adhere to the intervention and a demonstration that adherence can be measured; estimated numbers of young people potentially eligible for recruitment; key parameters of a potential future trial to include a justification of the choice and timing of an appropriate primary outcome measure.
A randomised element is not expected as part of this commission. A decision whether to advertise for a randomised controlled trial will be made at a later date once results of the feasibility report are known.
Anorexia nervosa (AN) is a serious mental health disorder associated with high mortality, morbidity and treatment costs - a meta-analysis showed mortality rates to be close to six times higher in AN when compared to expected population mortality rates. Prevalence is highest in teenage girls. Common comorbid conditions such as depression, anxiety and substance use disorders add significantly to the burden and the impact on patients, families and carers is devastating.
The recent update to the NICE Eating disorders guideline (NG69, 2017) highlights the very limited evidence base for pharmacological treatment. Given the wide use of psychotropic medication in the treatment of eating disorders, and lack of convincing evidence, the guideline committee agreed that a research recommendation was needed to examine the effectiveness of psychotropic medications in conjunction with treatment as usual, on the symptoms of eating disorders.
In NHS clinical practice antipsychotics are routinely prescribed off-label to adolescents and young adults with AN for symptomatic treatment and comorbid conditions. This is despite the considerable uncertainty of the balance of benefits and harms associated with these drugs. Observational studies and a few RCTs have indicated that antipsychotics, especially olanzapine, may be associated with improvements in weight gain, along with decreased anxiety and agitation and decreased obsessionality. However, findings are mixed and very few results are available for adolescents and young people. This is against a backdrop in which antipsychotics are commonly used pharmacotherapy for AN in NHS clinical practice. Clinical experts and reviews in the area all stress the need for a high quality trial to inform care in this vulnerable group of young people that may currently be receiving a drug that lacks much empirical evidence and has no guidance. Acknowledging that adherence to medication is a key factor due to recognised barriers to medication in this group, before considering commissioning a full trial, the HTA programme wishes to fund the feasibility work outlined above. Applicants should note that the cost of this study should be commensurate with the type of study being requested.
Making an application
The HTA Programme is pleased to announce that the Australian NHMRC is supporting this research and has made funds available for a collaborative bid with Australian Institutions. The NHMRC will consider funding an Australian arm for successful applications. Additional guidance for collaborative applications is available by clicking this link.
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted on-line no later than 1pm on the 4th December 2019. Applications will be considered by the HTA Funding Committee at its meeting in January.
IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May.
Applications received after 1300 hours on the due date will not be considered.
Should you have any queries please contact us:
Telephone: Commissioning Funding Committee 02380 595510