Are you still recruiting?
Yes, definitely! We'll be recruiting until 2021!
COVID UPDATE 06/11/2020: We are still recruiting participants, throughout lockdown. Our study has ethical approval to continue (with numerous safety measures in place - see below), in line with government guidance that allows research participation which cannot reasonably be done at home to continue throughout lockdown.
If I'm interested, what are the next steps?
What safety precautions are you taking with COVID-19?
We will send you documents outlining all of our safety procedures when you email us - these include screening all participants for vulnerability and current symptoms, completing as many procedures remotely as possible, taking everyone's temperature temperature before they enter any building, asking all participants to wear a mask during all visits, and having all staff follow rigorous hygiene and distancing procedures. All our procedures follow NHS, government and university guidance, and have been reviewed and approved.
Do I need a diagnosis of depression?
No - we are looking for people who have symptoms of depression but you do not need to have a diagnosis as we will assess this during the screening visit.
I feel low in mood sometimes - am I eligible for the study?
We are looking for people who have spent two weeks or more feeling low more days than not. You may have felt this way only recently, for a very long time, or on and off over your lifetime. Feeling low can be experienced differently by different people - you might feel sad and tearful, or anxious and overwhelmed, or you might just feel quite flat and apathetic, or very tired and unmotivated (or a mixture of these). This is in combination with enjoying things less than normal, and perhaps some physical changes such as disrupted sleep, headaches or muscle aches, or change in your eating habits. You do not need to have all of these symptoms or feel this way all of the time - you may have good days and activities you enjoy - but be struggling with some of this currently.
Everyone feels up and down occasionally - this is a normal part of life - but if you think the above description may apply to you, you may be eligible. We are very happy to discuss this on the phone with you or at a screening visit and do not mind at all if you are unsure.
What's the age-range?
You must be 18 or older, but no older than 65. This is partly for safety reasons because our bodies respond differently to drugs at different stages in our life.
Is this a treatment for depression?
No - this is an experimental research study to understand how the serotonin system works and how this drug changes the way people with depression process information. The hope is that this will help us develop new treatments, but we are not expecting the study to treat your symptoms and the drug is not available for treatment.
Is this a clinical trial?
No because it is not primarily looking at a change in symptoms or expecting to change symptoms - instead we're looking at cognitive changes and brain changes so it is an experimental research study. The drug has had phase 1 clinical trials to establish safety and appropriate doses in humans.
Do you reimburse travel expenses?
Yes! Just keep your receipts or copies/pictures of them.
....even if I live outside Oxford?
We can cover basic travel expenses for nearby cities (Reading, London, Birmingham etc), or contribute to reasonable travel costs from further.
Can I do the visit during the evenings or weekends?
Unfortunately no, because we need to ensure we have the right medical and nursing staff available and access to the necessary facilities and rooms. Therefore visits need to occur between 9am and 4.30pm.
How long do the visits take?
The screening visit usually takes 90 minutes (remote) and 30 minutes (in person, physical tests), the first dose visit takes about 3 and a half hours, the first research visit takes about 3 hours, and the final research visit takes about 3 and a half hours.
How much will I be reimbursed for taking part in the study?
You will be reimbursed £200 for the full study.
How long does reimbursement take?
Reimbursements are done via bank transfer through the University finance department and take 2-4 weeks.
How do I find you?
Our visits all occur at the Clinical Research Facility, located on the Warneford Hospital site in Oxford. The building is to the left of the main Warneford hospital reception. See map below!
Yes, definitely! We'll be recruiting until 2021!
COVID UPDATE 06/11/2020: We are still recruiting participants, throughout lockdown. Our study has ethical approval to continue (with numerous safety measures in place - see below), in line with government guidance that allows research participation which cannot reasonably be done at home to continue throughout lockdown.
If I'm interested, what are the next steps?
- The first step is to email us at restandstudy@psych.ox.ac.uk. We will then send you a summary of what the study involves, attach a participant information sheet, answer any basic questions you have. We will send you a link to answer some screening questions which will help determine if you are likely to be eligible for the study. Upon completion of the pre-screener, there will be a link to book a telephone screening with a researcher on the study.
- The second step is the telephone screening, with one of our research assistants which will last approximately 20-30 minutes. It will give you a chance to discuss the study in more detail, and will involve the researcher running through some questions to check you meet our core inclusion criteria. At the end of the call, we will book you in for a video screening with one of our medics ensure your suitability for the study (maximum 90 minutes).
- After this, if eligible, we will book you for physical tests, heart rate and blood pressure checks, ECG, blood and urine tests which takes place at the Warneford Hospital. Once these have been reviewed, we can book you in for the rest of the study visits (first dose, and 7 days later, the MRI scan and research visit, all at the at the Warneford Hospital).
What safety precautions are you taking with COVID-19?
We will send you documents outlining all of our safety procedures when you email us - these include screening all participants for vulnerability and current symptoms, completing as many procedures remotely as possible, taking everyone's temperature temperature before they enter any building, asking all participants to wear a mask during all visits, and having all staff follow rigorous hygiene and distancing procedures. All our procedures follow NHS, government and university guidance, and have been reviewed and approved.
Do I need a diagnosis of depression?
No - we are looking for people who have symptoms of depression but you do not need to have a diagnosis as we will assess this during the screening visit.
I feel low in mood sometimes - am I eligible for the study?
We are looking for people who have spent two weeks or more feeling low more days than not. You may have felt this way only recently, for a very long time, or on and off over your lifetime. Feeling low can be experienced differently by different people - you might feel sad and tearful, or anxious and overwhelmed, or you might just feel quite flat and apathetic, or very tired and unmotivated (or a mixture of these). This is in combination with enjoying things less than normal, and perhaps some physical changes such as disrupted sleep, headaches or muscle aches, or change in your eating habits. You do not need to have all of these symptoms or feel this way all of the time - you may have good days and activities you enjoy - but be struggling with some of this currently.
Everyone feels up and down occasionally - this is a normal part of life - but if you think the above description may apply to you, you may be eligible. We are very happy to discuss this on the phone with you or at a screening visit and do not mind at all if you are unsure.
What's the age-range?
You must be 18 or older, but no older than 65. This is partly for safety reasons because our bodies respond differently to drugs at different stages in our life.
Is this a treatment for depression?
No - this is an experimental research study to understand how the serotonin system works and how this drug changes the way people with depression process information. The hope is that this will help us develop new treatments, but we are not expecting the study to treat your symptoms and the drug is not available for treatment.
Is this a clinical trial?
No because it is not primarily looking at a change in symptoms or expecting to change symptoms - instead we're looking at cognitive changes and brain changes so it is an experimental research study. The drug has had phase 1 clinical trials to establish safety and appropriate doses in humans.
Do you reimburse travel expenses?
Yes! Just keep your receipts or copies/pictures of them.
....even if I live outside Oxford?
We can cover basic travel expenses for nearby cities (Reading, London, Birmingham etc), or contribute to reasonable travel costs from further.
Can I do the visit during the evenings or weekends?
Unfortunately no, because we need to ensure we have the right medical and nursing staff available and access to the necessary facilities and rooms. Therefore visits need to occur between 9am and 4.30pm.
How long do the visits take?
The screening visit usually takes 90 minutes (remote) and 30 minutes (in person, physical tests), the first dose visit takes about 3 and a half hours, the first research visit takes about 3 hours, and the final research visit takes about 3 and a half hours.
How much will I be reimbursed for taking part in the study?
You will be reimbursed £200 for the full study.
How long does reimbursement take?
Reimbursements are done via bank transfer through the University finance department and take 2-4 weeks.
How do I find you?
Our visits all occur at the Clinical Research Facility, located on the Warneford Hospital site in Oxford. The building is to the left of the main Warneford hospital reception. See map below!
Is there parking?
There is limited parking with pay and display.
Which buses can I get to the Warneford?
The 4A, 4B and 4C all stop near the Warneford!
What do I need to bring for the Screening Visit?
Nothing except photo ID!
There is no need to bring anything for any of the visits. However, during the first dose visit you may want to bring something to do while you are monitored - laptop, books etc.
Do I need to eat or drink differently before the visits or during the study?
No - though we advise participants not to drink alcohol during the week of study medication.
Who do I contact if I have a problem during the study?
During office hours you can contact a researcher on 07775 007621 or 07825 922120.
Out of hours and/or for immediate access to our on-call medics, please call 07469 906329.
In a medical emergency, call your out-of-hours GP or A&E as you would usually.
When do I find out which drug I was given?
When you have finished taking part in the study, you will be given an end-of-study review with a medic and they will be able to tell you which group you were in.
There is limited parking with pay and display.
Which buses can I get to the Warneford?
The 4A, 4B and 4C all stop near the Warneford!
What do I need to bring for the Screening Visit?
Nothing except photo ID!
There is no need to bring anything for any of the visits. However, during the first dose visit you may want to bring something to do while you are monitored - laptop, books etc.
Do I need to eat or drink differently before the visits or during the study?
No - though we advise participants not to drink alcohol during the week of study medication.
Who do I contact if I have a problem during the study?
During office hours you can contact a researcher on 07775 007621 or 07825 922120.
Out of hours and/or for immediate access to our on-call medics, please call 07469 906329.
In a medical emergency, call your out-of-hours GP or A&E as you would usually.
When do I find out which drug I was given?
When you have finished taking part in the study, you will be given an end-of-study review with a medic and they will be able to tell you which group you were in.