What is the ATP Trial?
ATP is short for ‘Antidepressant Trial with a P2X7 Antagonist’. The ATP Trial is part of the NIMA Consortium. The ATP Trial is testing whether using a new anti-inflammatory medication could help people who are still experiencing depression despite taking an antidepressant.
What is the NIMA Consortium?
Neuroimmunology of Mood Disorders and Alzheimer’s Disease. This consortium brings together researchers and scientists from the academic sector and pharmaceutical companies to study whether mood disorders, like depression, and neurodegenerative diseases, such as Alzheimer’s disease, could be treated by targeting the immune system.
Is it safe for me to take part?
The ATP Trial has been reviewed and approved by East of England- Cambridge Central Research Ethics Committee and by the Medicines and Healthcare Products Regulatory Agency (MHRA).
This is a phase two trial, the trial drug has previously been used in a phase 1 study on 300 participants and has shown to be very safe. Approximately 1-10% of people reported having headaches, fatigue and nausea. All of these symptoms stopped when they stopped taking the medication. Your safety is our top priority. If you are eligible and chose to participant you will be monitored closely and if we find out anything new relating to the trial drug you will be informed.
Do I have to take part?
It is entirely your choice whether to take part. We want to make sure you understand what is involved in the trial and that you feel confident about taking part. You will have another chance to read through the Participant Information Sheet at your screening visit and ask any questions you may have. If you are happy, we will ask you to sign a consent form at your screening visit.
What if I change my mind?
You can change your mind about taking part at any time in the trial. At each of your visits with us we check that you understand what is involved and that you are happy to continue. You do not need to give us any reason for deciding to stop taking part and your medical care will not be affected in any way. If you decide to stop taking part in the trial we will not gather any more data from you but the data we have already gathered will still be analysed. In some circumstances the trial team may also decide to withdraw you from the trial.
What would make me eligible to take part?
What would make me unable to take part?
Do the visits have to take place on certain days?
Our visits have to take place within certain windows of time. We will chat with you before you start the trial to check your availability in principle. In some situations we will book all of your visits in advance as soon as we know if you are eligible as this can be helpful for some people. If you have any concerns about your availability for visits please speak to your local team.
What steps are you taking to reduce the spread of COVID-19?
We work in line with government guidelines to reduce the spread of COVID-19. Many of our research centres are located in hospitals so will also have some local guidelines set out by specific hospitals.
We ask that if you feel unwell at all in the days before your visit to let your local team know. They will then assess whether it is appropriate for you to attend your visit or whether to postpone until you feel better. If you have any symptoms of COVID-19 (temperature, cough, loss/change in sense of smell or taste) we ask that you not attend your visit and inform your local team as soon as possible.
At your visit you will be asked to wear a mask if you can and to wash your hands when you arrive at the research centre. The staff that you meet will also wear masks and depending on local guidelines other PPE (Personal Protective Equipment). We know that this can make communication more difficult but our friendly research teams will do everything they can to make you feel more comfortable.
All of our staff adhere to local and national guidelines in order to protect our participants. Any staff member who has any Covid 19 symptoms or a positive test result will not attend your visit, in some cases we may have to rearrange your visit for another time.
As guidelines are constantly changing please do not hesitate to contact your local team to get up-to-date information on what they are doing to help keep people safe during the COVID-19 pandemic.
Can I bring a carer or supporter with me?
We understand that coming in for a trial visit in a research facility can be challenging and having a friend or relative come with you can help. Unfortunately, as many of our research facilities are based in hospitals we have been advised that participants are asked to attend their visits alone. However, if you were concerned about this we would encourage you to speak to your local team as they may be able to see what could be done. We want to make sure you feel as supported and comfortable as you can during your visits.
What does BMI mean and why is it important to the study?
BMI stands for Body Mass Index. It is calculated from your height and weight. It is important to us because drug concentration varies across different BMIs.
I am not currently taking antidepressants, can I still take part?
The ATP Trial is only recruiting people who are currently taking antidepressants and who still have symptoms of depression. So, you would not be able to take part in the ATP Trial. However, our sister study, BICBID, is looking for people who have depression but are not taking antidepressants and people who have never had depression. More information about BICBID is available here.
I am only available on weekends and the evenings. Can I still take part?
Visits for the ATP Trial take place Monday – Friday during normal working hours. If you have concerns about this please speak to your local team who will be able to discuss options that may work for you. Please read our Participant Information Sheet for full details of the trial, you can download this here. If you have any further questions please contact your local team, they would like to help. You can find the contact details for all of our research teams here.