Why are we doing this study?
Some people who have had shingles, can have nerve pain in the area of the shingles rash, months after the rash has gone. This is called “post-herpetic neuralgia”. We currently do not have any treatments that prevent this.
We want to find out if taking a low dose of a tablet called amitriptyline may help prevent it. The only way to find out if amitriptyline helps is by doing a clinical trial. We are also interested in understanding how common it is for people to have problems with the treatment and how people find taking the medication alongside any other tablets.
We are also interested to compare the cost and effectiveness of amitriptyline with other pain-relieving treatment and the use of healthcare resources.
Who can take part?
We need the help of 846 people with newly diagnosed shingles to join the study to enable us to answer the question, “Does taking amitriptyline when the rash of shingles first appears prevent post-herpetic neuralgia?”
You can take part if you are registered with one of our participating GP Surgeries, you are an adult 50 years or older who has just been diagnosed with shingles AND your GP says you are eligible to take part.
What is involved in taking part in the study?
If you agree to take part:
- You will be asked to take tablets nightly for 10 weeks.
- Over the following 12 months, you will be asked to complete seven questionnaires, each 5-10 minutes long.
All of your other medical care will be the same.
If you agree, we may also ask if we can interview you, to get your views on being invited to the study and your experiences of taking part.
More about amitriptyline
Amitriptyline has been used since the 1960s, so it is not new medication.
Originally it was used at high doses (75-150 mg) to treat depression, nowadays it is used at low dose (10-30 mg) to treat problems like nerve pain.
In this study, we are trying to find out whether low dose amitriptyline can actually prevent the nerve pain caused by shingles.
You will be given amitriptyline or placebo (“dummy”) pills to take nightly for 70 days.
A process called “randomisation” (a bit like rolling dice) will decide which group you go into. This will ensure that the results cannot be affected by anyone’s beliefs about amitriptyline.
Like all tablets, even at low dose some people may get side-effects. We will monitor these and you will be able to discuss any problems with the study team or your GP.
You, nor your GP will know which tablets you are taking, but in an emergency, we can quickly tell you which group you are in and whether you are taking amitriptyline or a placebo.If you are unable to take the medication or you change your mind, you can stop taking the tablets and/or withdraw from the study at any time.
How long does the study last and what will happen to the results?
The study is expected to run from 2021 through to 2024. No one will be able to identify you from any of the study reports/publications.
Study information leaflets
Participant Summary Sheet: ATHENA Patient summary
Patient Information Leaflet: ATHENA PIL