Timeline of clinical trial

Screening

First, we will invite you to a meeting where we will talk to you about your history and current circumstances in depth to help us decide. You will need to provide a blood sample for routine laboratory tests, have a heart tracing (called an electrocardiogram (ECG)) and consent to your GP or community mental health team sharing the information they hold about you with us.

We will also conduct a physical examination at this screening visit and at any other visit if the study doctor think this is necessary. A doctor will then go through this information and make a decision with you about your suitability for the study

Preparation Visits

Depending on your circumstances and the information we receive, we may ask you to come and see us to monitor your medication and mental health and help you prepare for your treatment. We may also do this over the phone or internet if it’s more convenient.

These visits are likely to be brief.
You will also meet your trial therapist during one of these visits

Baseline Visit

The baseline visit will be 1 or 2 days before your treatment. We will ask you to complete a number of questionnaires and donate a blood sample. You will meet your therapist and a chaperone who will be your companions on the day of your treatment.

You will spend some time getting to know each other. Optionally, we will ask you to have an MRI brain scan. We will show you the room where you will have your treatment. This visit could last all day.

Treatment visit 1 part 1

On the day of your treatment there will not be much to do except arrive with an open, curious mind and let us take care of you. You will arrive in the morning at about 9am.

Bring comfortable clothes to change into – the sort that you’d wear to relax at home. We will provide you with headphones, but feel free to bring your own, if you would like to use these to listen to the music playlist. You might like to bring in a picture of a loved one, an object that has special significance to you or something else that will help you to feel comfortable and relaxed.

Your therapist and chaperone will be with you all day. We will give you your treatment at about 10am. No one in the study team knows which treatment you are going to get, but remember if you don’t think you’ve had the active treatment there is the option in 12 weeks’ time to definitely receive the active treatment, unless you don’t want it or we think you shouldn’t receive it. We will provide you with food and drink.

Treatment visit 1 part 2

After you’ve swallowed the treatment, you mustn’t leave until the study doctor tells you that you can. If you try to leave then we may try and stop you if we think you are a risk to yourself or others.

Even if you don’t think you’ve received the active treatment you will need to stay until everyone is satisfied it is safe for you to leave. Remember that no one knows what you have taken (including you) and sometimes psilocybin can take a long time to have an effect.

The treatment can cause unusual experiences, emotions and sensations. This is entirely normal and once the treatment has worn off you will come back to where you were when you arrived. It’s like throwing a boomerang.

Your therapist and chaperone will help you work through any difficult experiences, which may be directly psychologically related to your depression. Do not worry – you are safe, even if it might not feel like that. When the treatment has finished and the study team is happy for you to leave you can go home.