After you volunteer for the psilocybin trial.

After you volunteer we will meet you and work through the stages involved in the trial.

After you volunteer to take part in the psilocybin treatment resistant depression trial, the stages listed below are involved, please read and consider them carefully before you volunteer.


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.

Post treatment visit 1

1 or 2 days (usually 1) after your treatment, we will ask you to come in and meet with your therapist, chaperone and the study team. You will have time to talk through what happened for you during your treatment and your therapist will help you find your way through anything you are finding difficult.

We will go through some questionnaires with you and ask you for a blood sample and a heart tracing. You can then go home.

Post treatment visit 2

1 week after your treatment we will ask you to come in and meet with your therapist, chaperone and the study team. You will have time to talk through what happened for you during your treatment and your therapist will help you find your way through anything you are finding difficult.

We will go through some questionnaires with you and ask you for a blood sample and a heart tracing. We will ask you to have an MRI brain scan, which is optional. You can then go home.

Post treatment visit 3

3 weeks after your treatment we will ask you to come in and meet with the study team. We will go through some questionnaires with you and ask you for a blood sample. You can then go home.

Post treatment visit 4

6 weeks after your treatment we will ask you to come in and meet with the study team. We will go through some questionnaires with you and ask you for a blood sample. You can then go home.

During the 6 week follow up period you will be able to speak to a psychiatrist, therapist or other member of the study team if you are struggling or experiencing other difficulties. We can make a plan with you to try and help.

During the 6 week follow up period we may speak to your nominated friend or relative to ask them how they think you are.

During the 6 week period after your first treatment we will decide with you whether you are eligible for a further treatment. This is optional. If we have decided with you not to go ahead with a further treatment, then this will be your last visit and after this we will return your care to your GP or other care team.

If we have decided with you to go ahead with a further treatment then we will ask you for a urine sample, you will meet your  therapist again and we will ask you to fill out some more questionnaires. You can then go home.

Post treatment visit 5

1 or 2 days (usually 1) after your treatment, we will ask you to come in and meet with your therapist, chaperone and the study team. You will have time to talk through what happened for you during your treatment and your therapist will help you find your way through anything you are finding difficult.

We will go through some questionnaires with you and ask you for a blood sample and a heart tracing. You can then go home.

Post treatment visit 6

1 week after your second treatment we will ask you to come in and meet with your therapist, chaperone and the study team. You will have time to talk through what happened for you during your treatment and your therapist will help you find your way through anything you are finding difficult. We will go through some questionnaires with you. You can then go home.

Post treatment visit 7

3 weeks after your treatment we will ask you to come in and meet with the study team. We will go through some questionnaires with you and ask you for a blood sample. You can then go home.

Post treatment visit 8

6 weeks after your treatment we will ask you to come in and meet with the study team. We will go through some questionnaires with you and ask you for a blood sample. You can then go home.

During the 6 week follow up period you will be able to speak to a psychiatrist, therapist or other member of the study team if you are struggling or experiencing other difficulties. We can make a plan with you to try and help.

During the 6 week follow up period we may speak to your nominated friend or relative to ask them how they think you are.

During the 6 week period after your first treatment we will decide with you whether you are eligible for a further treatment. This is optional. If we have decided with you not to go ahead with a further treatment, then this will be your last visit and after this we will return your care to your GP or other care team.

If we have decided with you to go ahead with a further treatment then we will ask you for a urine sample, you will meet your chaperone and therapist again and we will ask you to fill out some more questionnaires. You can then go home.

Why do you need blood samples?

We need blood samples to perform routine laboratory tests to determine your eligibility and monitor you after the treatment. If you do not consent to these then you will not be able to participate in the trial.

We are also collecting blood samples to freeze down and store so that we can understand how the treatment works by measuring different proteins and other biological factors in the blood. This is optional.

Why do you need urine samples?

We need urine samples to perform routine laboratory tests to determine your eligibility and to perform pregnancy tests on women of childbearing age. If you do not consent to these then you will not be able to participate in the trial.

Why do you need a heart tracing (ECG)?

We need ECGs to check the health of your heart to determine your eligibility. If you do not consent to these then you will not be able to participate in the trial.

Why are there so many questionnaires!?

We need to understand about your depression and the wider circumstances around this, so we can understand how (and if) the treatment works. We have to use properly validated, well researched questionnaires so that we can be sure we are measuring what we think we are measuring. It is the only way to make sure that the research is valid (that is, not a waste of everyone’s time).

Will you pay me to be in this trial?

No. We will compensate you for travel costs but you will not be paid to take part in this trial.

Will my participation be kept confidential?

We will only tell your GP, care team and your nominated friend or relative about your participation in this trial. If you do not consent to this then you will not be able to take part in the trial.

What if I don’t get the treatment I am expecting?

Half of people will get a placebo (dummy pill) at their first treatment. Half will get the active treatment (psilocybin). Neither you nor the study team will know beforehand which treatment you will get. This is the only way to know for sure whether the active treatment is safe and effective.

If you complete the follow up period after your first treatment (6 weeks) and you are still eligible and consent, then we will offer you a further treatment where you will receive the active treatment (psilocybin).

What if I get worse during my participation?

We will help you access the care and treatment you need. This may mean restarting your conventional treatments for depression. If this happens before the study treatment, then we may decide that you shouldn’t participate in the trial.

What if I am in crisis?

Please see the Contact Us page for contact details for various support services. During office hours you can call the study team. Out of office hours there is an emergency mobile phone number, however since we are not resourced to provide an out of hours service we cannot guarantee that this will be answered. Therefore, please use your usual out of hours crisis service in preference.