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.
I still feel low sometimes, despite my antidepressant treatment, but not as bad as before - am I eligible?
We are looking for people who are currently still feeling low more days than not. You may have noticed an improvement since taking antidepressants - maybe you feel low less often, or less intensely - but still have some lingering symptoms of depression. You may have felt this way only recently, ever since starting antidepressants, or on and off. 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 some of the other symptoms of depression such as struggling to enjoy things in your day to day life, and physical symptoms such as disrupted sleep, headaches or muscle aches, or poor appetite. Again, these symptoms may have improved somewhat but not fully. 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.
Does it matter which antidepressant I'm on?
Yes, please see the lists below.
Fine for inclusion in the study:
- citalopram
- escitalopram
- sertraline
- venlafaxine
- duloxetine
Can include in the study, if willing to switch medications before commencing (see below):
- fluoxetine
- paroxetine
- fluvoxamine
Cannot include in the study
- reboxetine
- amitriptyline
- trimipramine
- mirtazapine
- bupropion
- amisulpride
- quetiapine
- lithium
If you are taking an antidepressant not listed above, or if you are taking an antidepressant as well as another psychiatric medication, you would need to discuss this with the study team.
What happens if I'm currently taking fluoxetine (prozac), paroxetine or fluvoxamine?
Because of potential negative interactions between this medication and the study medication, to take part in the study you would need to change to citalopram or sertraline. You would first come in for a condensed screening visit, to check you are broadly eligible to take part. You would then be prescribed citalopram or sertraline by one of our study medics for at least 4 weeks (longer if we need to slowly reduce your current medication), in consultation with your GP/normal psychiatrist. After this period on citalopram or sertraline, you would then come in again for a screening to assess your current symptoms and check if you are still eligible. You would then take part in the study as normal.
Do you reimburse travel expenses?
Yes! Just keep your receipts or copies/pictures of them.
....even if I live outside Oxford?
Yes! 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, and the 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 £170 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 restartstudy@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, and include a link to answer some basic screening questions which will help determine if you are likely to be eligible for the study. Upon completion of these questions, there will be a link to book a telephone call with a researcher on the study.
- The second step is the telephone call, with one of our research assistants which will last approximately 15 minutes. It will give you a chance to discuss the study in more detail, and will involve the researcher confirming a few details to ensure 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 for a full screening assessment (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 research visit, both 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.
I still feel low sometimes, despite my antidepressant treatment, but not as bad as before - am I eligible?
We are looking for people who are currently still feeling low more days than not. You may have noticed an improvement since taking antidepressants - maybe you feel low less often, or less intensely - but still have some lingering symptoms of depression. You may have felt this way only recently, ever since starting antidepressants, or on and off. 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 some of the other symptoms of depression such as struggling to enjoy things in your day to day life, and physical symptoms such as disrupted sleep, headaches or muscle aches, or poor appetite. Again, these symptoms may have improved somewhat but not fully. 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.
Does it matter which antidepressant I'm on?
Yes, please see the lists below.
Fine for inclusion in the study:
- citalopram
- escitalopram
- sertraline
- venlafaxine
- duloxetine
Can include in the study, if willing to switch medications before commencing (see below):
- fluoxetine
- paroxetine
- fluvoxamine
Cannot include in the study
- reboxetine
- amitriptyline
- trimipramine
- mirtazapine
- bupropion
- amisulpride
- quetiapine
- lithium
If you are taking an antidepressant not listed above, or if you are taking an antidepressant as well as another psychiatric medication, you would need to discuss this with the study team.
What happens if I'm currently taking fluoxetine (prozac), paroxetine or fluvoxamine?
Because of potential negative interactions between this medication and the study medication, to take part in the study you would need to change to citalopram or sertraline. You would first come in for a condensed screening visit, to check you are broadly eligible to take part. You would then be prescribed citalopram or sertraline by one of our study medics for at least 4 weeks (longer if we need to slowly reduce your current medication), in consultation with your GP/normal psychiatrist. After this period on citalopram or sertraline, you would then come in again for a screening to assess your current symptoms and check if you are still eligible. You would then take part in the study as normal.
Do you reimburse travel expenses?
Yes! Just keep your receipts or copies/pictures of them.
....even if I live outside Oxford?
Yes! 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, and the 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 £170 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?
At the end of the study, once all the data has been collected, you will be able to find out which drug you were on during the end-of-study review with a medic.
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?
At the end of the study, once all the data has been collected, you will be able to find out which drug you were on during the end-of-study review with a medic.