You are seeing this information because you are taking part, or may be taking part, in the ‘Psilocybin in Depression Resistant to standard clinical depression treatment (PsiDeR) trial’. This Neuroimaging part of the trial is optional and if you decide not to take part, your care, treatment and participation in the main arm of the trial will not be affected in any way.
Psilocybin may be a new clinical depression treatment and we would like to understand more about how it is working in the brain. To do this we need to collect data from brain scans of people in the PsiDeR trial before and after their treatment.
This information will help you decide whether you would like to take part. You do not have to and if you decide not to, your care and treatment will not be affected in any way. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. You can take as much time as you like to decide.
The purpose of this part of the study is to understand how a proposed new clinical depression treatment called psilocybin works in the brain.
Psilocybin is a drug that causes certain parts of the brain to operate in a different way to usual. Research in healthy volunteers has shown that psilocybin changes activity in areas of the brain which are over-active in people with depression. We want to know whether activity in these areas change when neither the participants nor the study team know whether psilocybin or a placebo has been given.
We are asking people to take part in the study if they:
Are eligible for the PsiDeR trial.
Can safely have an MRI brain scan.
No. If you decide not to take part your care and clinical depression treatment will not be affected. If you do decide to take part you can withdraw at any time. You can take as much time as you need to decide whether you want to take part.
You will be helping with clinical research, which may help others in the future.
We may find an abnormality that you didn’t know you had. This is unusual, but if it does happen then we will talk to you and help you decide what to do. If we find something that can be treated, then this may be a benefit to you because of that early clinical depression treatment.
We will keep in touch with you to let you know the results of the study if you wish and we will organise events to help raise awareness about the results of the study. We will ask for your consent to contact you about other studies in depression or with psilocybin that might interest you.
Because psilocybin has a colourful history, it is quite likely that the media will be interested in this part of the trial. We will never tell the media that you are involved in the study. However, if the media approach you then we ask you not to talk to them, but refer them to the Principal Investigator of the study, who is Dr James Rucker.
Any complaint about your experience within the study will be responded to and we will try to address any concerns you have as best we can. Please contact Dr. James Rucker if you have any complaints about the study. You can also talk to an independent body, such as your local Patient Advice and Liaison Service (PALS). You can find your nearest PALS office on the NHS Choices website or by asking your GP surgery, hospital or by phoning NHS Direct on 111.
What will happen to me if I take part?
We will ask you to have two MRI brain scans. The MRI scans will happen on days when we will be asking you to come to the Clinical Research Facility anyway to meet with us as part of the trial. This is to minimise disruption to you. The first MRI scan will be one or two days before your treatment. The second MRI scan will be 1 week after your clinical depression treatment.
Each scan will last 1 hour and take place at the Centre for Neuroimaging Sciences at King’s College London. The centre is a 5 minute walk from the Clinical Research Facility, where the PsiDeR trial takes place. We will accompany you there.
Before the MRI scans, we will ask you some questions to determine whether you can safely have an MRI brain scan.
If you feel unsure about whether you will be comfortable in the MRI scanner then we can arrange a practice session with you where you can lie in the scanner. We will not collect any data.
During the brain scan we will give you ear plugs to wear (the scanner can be noisy) and ask you to lie still and let your mind wander. For most of the scan this is all you will need to do. For about 20 minutes of the scan we will ask you to look at a series of faces with different expressions and occasionally press a button. We will go through what we need you to do in detail on the day of the scan.
There are no known health dangers from having an MRI scan and no radiation or ‘X-rays’ are involved. If you have any metal in your body (such as a pacemaker, lots of tatoos or surgical clips) then you will need to tell us about this because metal objects can cause serious problems in an MRI scanner and it may mean you are ineligible for this part of the study. We will talk to you about this before the scan and if necessary get more information from your GP. You will have to take all metal jewellery and other metal objects off before you go into the MRI scanner.