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20/74 Antidepressants for post-stroke emotionalism

 

Contents

Introduction

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

What is the clinical and cost-effectiveness of antidepressants for post-stroke emotionalism in adults?

  1. Intervention: Antidepressant/s.  Applicants to define and justify the choice of antidepressant/s, dose and regimen.
  2. Patient group: Adults with post-stroke emotionalism. Exact inclusion criteria to be defined and justified by applicants. Applicants should take into consideration comorbid symptoms of depression and length of time since stroke. 
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Any appropriate setting. Applicants to define and justify.
  4. Control: Placebo.
  5. Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: Symptoms of emotionalism, adverse events.
    Other outcomes: Symptoms of depression, cognitive functioning, activities of daily living, social functioning, impact on relationships, quality of life, patient acceptability, cost-effectiveness. 
    Where established Core Outcomes exist, they should be included amongst the list of outcomes unless there is good reason to do otherwise.
  7. Minimum duration of follow-up: 1 year.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Post-stroke emotionalism is an under-recognised and under-treated neurological condition, distinct from a mood disorder. It is also variously referred to by other terms including pseudobulbar affect, pathological laughing and crying or emotional lability. The condition is diagnosable based on the presence of involuntary, unpredictable and uncontrollable crying or laughing which is usually incongruent with mood. There are recognised scales and outcome measures available. Approximately one fifth of stroke survivors experience post-stroke emotionalism.

The symptoms can be distressing and embarrassing and lead to people avoiding social contact and communication. This avoidance can have a negative impact on a person’s mood, relationships and ultimately post-stroke recovery.

Although it is encouraging that deaths related to stroke have declined significantly in the last fifteen years, two thirds of these survivors are left with significant disabilities, emotionalism being one of them. A recent Cochrane review has highlighted this neglected condition and the clinical uncertainty about how it should be treated. Antidepressants are currently recommended by the National Clinical Guideline for Stroke to treat post-stroke emotionalism, but this recommendation is based on inadequate evidence. Robust research data of a sufficient duration and follow-up and that includes careful assessment and complete reporting of adverse events is needed.  

The debilitating symptoms of post-stroke emotionalism may be helped by antidepressants. Conversely it may be that this medication is being recommended and used for no discernible patient benefit and with the associated risks of side effects. The HTA programme is interested in commissioning research to resolve this uncertainty.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

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 2nd December 2020. Applications will be considered by the HTA Funding Committee at its meeting in January 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

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 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us

Email:

htacommissioning@nihr.ac.uk