Click on the below frequently asked questions to find specific answers, or scroll down to browse the FAQs. Study outline The study visits
- What visits does the study involve, and how long do they take?
- What happens during the visits?
- Do I have to do anything during the 7 day period between my first dose and research visit?
- What COVID-19 safety precautions are you taking?
- Can I do the visit during the evenings or weekends?
- What do I need to bring for the visits?
- Do I need to eat or drink differently before the visits or during the study?
- Who do I contact if I have a problem during the study?
- When do I find out which drug I was given?
- Am I eligible to take part?
- What's the age-range for eligible participants?
- I still feel low sometimes, despite my antidepressant treatment, but not as bad as before - am I eligible?
- Does it matter which antidepressant I'm on?
- What happens if I'm currently taking fluoxetine (prozac), paroxetine or fluvoxamine?
- I’m interested but I’m not on an antidepressant currently – can I take part?
Are you still recruiting?
Yes, definitely! We'll be recruiting until 31st May 2021 at least!
Even with COVID?
Yes, with new protocols to look after the safety of participants and staff. Our study received ethical approval to resume during the late 2020 lockdown and this is approval is ongoing throughout the current restrictions. This is in line with government guidance that allows research participation which cannot reasonably be done at home to continue. You can find out more about our safety procedures below.
Yes, definitely! We'll be recruiting until 31st May 2021 at least!
Even with COVID?
Yes, with new protocols to look after the safety of participants and staff. Our study received ethical approval to resume during the late 2020 lockdown and this is approval is ongoing throughout the current restrictions. This is in line with government guidance that allows research participation which cannot reasonably be done at home to continue. You can find out more about our safety procedures below.
If I'm interested, what are the next steps?
The first step is to email us at restartstudy@psych.ox.ac.uk. We will answer any initial questions you have, and send you a link to a short set of questions (2-3 minutes) which will help rule out common reasons participants are ineligible to take part. At the end of these questions, there will be a link to book a short telephone call with a researcher on the study.
This telephone call will last 10-15 minutes and will give you a chance to discuss the study in more detail. The researcher will confirm some details about you and ensure you meet our core inclusion criteria. They will then book you in for a full screening assessment with one of our medics (Beata or Angharad) – these are currently being done remotely, using Microsoft Teams or a phone call.
Only at this point will we arrange any in-person visits. If eligible for the study based on the medic assessment, we will book you in for a physical health screen and the two study visits. A medic will review the results of your physical health screen before giving you the first dose, to ensure you are in good health before taking a new medication.
The first step is to email us at restartstudy@psych.ox.ac.uk. We will answer any initial questions you have, and send you a link to a short set of questions (2-3 minutes) which will help rule out common reasons participants are ineligible to take part. At the end of these questions, there will be a link to book a short telephone call with a researcher on the study.
This telephone call will last 10-15 minutes and will give you a chance to discuss the study in more detail. The researcher will confirm some details about you and ensure you meet our core inclusion criteria. They will then book you in for a full screening assessment with one of our medics (Beata or Angharad) – these are currently being done remotely, using Microsoft Teams or a phone call.
Only at this point will we arrange any in-person visits. If eligible for the study based on the medic assessment, we will book you in for a physical health screen and the two study visits. A medic will review the results of your physical health screen before giving you the first dose, to ensure you are in good health before taking a new medication.
Study Outline
What’s the core aim of the study?
The aim of RESTART is to investigate how a new medication affects emotional decision making. We are particularly interested in how the new medication works when given to someone already on an antidepressant. Understanding the mechanism of this medication – which works on the serotonin system in a different way to current antidepressants - may help improve our understanding of depression and development of novel treatments.
What’s the core aim of the study?
The aim of RESTART is to investigate how a new medication affects emotional decision making. We are particularly interested in how the new medication works when given to someone already on an antidepressant. Understanding the mechanism of this medication – which works on the serotonin system in a different way to current antidepressants - may help improve our understanding of depression and development of novel treatments.
Is this a treatment for depression?
No – this study is not providing a treatment. RESTART 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.
No – this study is not providing a treatment. RESTART 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 and we are not expecting to change symptoms in one week - instead we are looking at early cognitive changes. The drug has had Phase 1 clinical trials to establish safety and appropriate doses in humans.
No because it is not primarily looking at a change in symptoms and we are not expecting to change symptoms in one week - instead we are looking at early cognitive changes. The drug has had Phase 1 clinical trials to establish safety and appropriate doses in humans.
The study visits
What visits does the study involve, and how long do they take?
The study includes a remote screening assessment, a physical health screen, a first dose visit, taking medication for 7 days, and a research visit.
The remote screening assessment with a medic typically takes between 1 hour and 1.5 hours.
The physical health screen typically takes 30 minutes.
The first dose visit takes 3.5 hours.
The research visit takes 3.5 hours.
What visits does the study involve, and how long do they take?
The study includes a remote screening assessment, a physical health screen, a first dose visit, taking medication for 7 days, and a research visit.
The remote screening assessment with a medic typically takes between 1 hour and 1.5 hours.
The physical health screen typically takes 30 minutes.
The first dose visit takes 3.5 hours.
The research visit takes 3.5 hours.
What happens during the visits?
The remote screening assessment is a conversation with a medic about your medication, physical and mental health (past and current), and lifestyle.
The physical health screen will be run by a research nurse who measures your height and weight, checks your heart rate and blood pressure, conducts an ECG (to measure your heart activity), and takes a urine sample (for drug use and pregnancy) and a blood sample (for general health). The ECG involves attaching electrodes to your chest, arm and ankle.
The first dose visit will be run by a researcher who will first review that there have been no changes since your screening visits and ask you to complete some questionnaires. A research nurse will take your blood pressure and a urine sample at the start of the visit. You will then be given a first dose of drug or placebo, and stay in the CRF for 3 hours with regular blood pressure checks. During this time you can use your laptop, read a book etc. At the end of the visit, you will be reviewed by a medic, given instructions for the following week, and go home.
The research visit will be run by a researcher who will ask you questions about your mood over the week of the study, and guide you through a set of questionnaires and cognitive tasks on a computer. You can take breaks as you need. At the start or end of the visit, you will have the ECG and urine test repeated.
The remote screening assessment is a conversation with a medic about your medication, physical and mental health (past and current), and lifestyle.
The physical health screen will be run by a research nurse who measures your height and weight, checks your heart rate and blood pressure, conducts an ECG (to measure your heart activity), and takes a urine sample (for drug use and pregnancy) and a blood sample (for general health). The ECG involves attaching electrodes to your chest, arm and ankle.
The first dose visit will be run by a researcher who will first review that there have been no changes since your screening visits and ask you to complete some questionnaires. A research nurse will take your blood pressure and a urine sample at the start of the visit. You will then be given a first dose of drug or placebo, and stay in the CRF for 3 hours with regular blood pressure checks. During this time you can use your laptop, read a book etc. At the end of the visit, you will be reviewed by a medic, given instructions for the following week, and go home.
The research visit will be run by a researcher who will ask you questions about your mood over the week of the study, and guide you through a set of questionnaires and cognitive tasks on a computer. You can take breaks as you need. At the start or end of the visit, you will have the ECG and urine test repeated.
Do I have to do anything during the 7 day period between my first dose and research visit?
Only keep taking your medication every day, and answer an online questionnaire about side effects on certain days.
Only keep taking your medication every day, and answer an online questionnaire about side effects on certain days.
What COVID-19 safety precautions are you taking?
We will send you up-to-date documents outlining all of our current safety procedures when you email us. These include:
We will send you up-to-date documents outlining all of our current safety procedures when you email us. These include:
- vaccinating all staff and taking lateral flow tests twice a week
- screening all participants for vulnerability and current symptoms
- completing as many procedures remotely as possible
- strict numbers on the number of people in any building or room at one time
- taking everyone's temperature before they enter any building
- asking all participants to wear a mask during all visits
- having all staff follow rigorous hygiene, PPE and distancing procedures
Can I do the visits 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 5pm.
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 5pm.
What do I need to bring for the visits?
Nothing except your photo ID at the physical health check.
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.
Nothing except your photo ID at the physical health check.
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.
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 via the phone number you are told at your dosing visit.
Out of hours, if you need to speak with an on-call medic, please ring the Warneford reception on 01865 901000 and ask for the doctor on call for the Clinical Research Study Rota.
In a medical emergency, call your out-of-hours GP or A&E as you would usually.
During office hours you can contact a researcher via the phone number you are told at your dosing visit.
Out of hours, if you need to speak with an on-call medic, please ring the Warneford reception on 01865 901000 and ask for the doctor on call for the Clinical Research Study Rota.
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 an end-of-study review call with a medic.
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 an end-of-study review call with a medic.
Eligibility
Am I eligible to take part?
If you are aged between 18-65, taking an antidepressant (see below for a list of accepted antidepressants) but still suffering with symptoms of depression, physically healthy, and able to attend our visits in Oxford, you may well be eligible to take part. A medic will need to discuss your physical and mental health history at a screening assessment to be certain.
Am I eligible to take part?
If you are aged between 18-65, taking an antidepressant (see below for a list of accepted antidepressants) but still suffering with symptoms of depression, physically healthy, and able to attend our visits in Oxford, you may well be eligible to take part. A medic will need to discuss your physical and mental health history at a screening assessment to be certain.
What's the age-range for eligible participants?
You must be at least 18 years old, but no older than 65. This is partly for safety reasons because our bodies respond differently to drugs at different stages in our life.
You must be at least 18 years old, but no older than 65. This is partly for safety reasons because our bodies respond differently to drugs at different stages in our life.
I still feel low sometimes, despite my antidepressant treatment, but not as bad as before - am I eligible?
In short, 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 notable 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.
In short, 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 notable 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.
Does it matter which antidepressant I'm on?
Yes. We are ideally looking for participants taking any of the below antidepressants:
- citalopram
- escitalopram
- sertraline
- venlafaxine
- duloxetine
If you are taking any of the below studies, we can include you in the study but only if you are willing to switch medications before commencing (see below):
- fluoxetine
- paroxetine
- fluvoxamine
If you are taking any of the below antidepressants, unfortunately we cannot include you in the study because they work in very different ways to the antidepressants listed above:
- 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.
Yes. We are ideally looking for participants taking any of the below antidepressants:
- citalopram
- escitalopram
- sertraline
- venlafaxine
- duloxetine
If you are taking any of the below studies, we can include you in the study but only if you are willing to switch medications before commencing (see below):
- fluoxetine
- paroxetine
- fluvoxamine
If you are taking any of the below antidepressants, unfortunately we cannot include you in the study because they work in very different ways to the antidepressants listed above:
- 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, assuming it is safe and in your best interests for you to do so. You would first complete a condensed screening process, 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 full screening to assess your current symptoms and check if you are still eligible. You would then take part in the study as normal.
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, assuming it is safe and in your best interests for you to do so. You would first complete a condensed screening process, 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 full screening to assess your current symptoms and check if you are still eligible. You would then take part in the study as normal.
I’m interested but I’m not on an antidepressant currently – can I take part?
You would not be able to take part in RESTART – however, if you are experiencing low mood and have not taken an antidepressant or any other psychiatric medication for at least six weeks, you may be eligible for RESTAND.
You would not be able to take part in RESTART – however, if you are experiencing low mood and have not taken an antidepressant or any other psychiatric medication for at least six weeks, you may be eligible for RESTAND.
Travel and reimbursement
How much will I be reimbursed for taking part in the study?
You will be reimbursed £170 for the full study. If you only take part in the screening visit, or drop out during the study, you will be reimbursed proportionate to your time in the study.
There is also the opportunity to win up to an additional £10 on one of our computer tasks in the final visit.
How much will I be reimbursed for taking part in the study?
You will be reimbursed £170 for the full study. If you only take part in the screening visit, or drop out during the study, you will be reimbursed proportionate to your time in the study.
There is also the opportunity to win up to an additional £10 on one of our computer tasks in the final visit.
Do you reimburse travel expenses?
Yes! Just keep your receipts or copies/pictures of them.
....even if I live outside of Oxford?
Yes! We can cover basic travel expenses for nearby cities (Reading, London, Birmingham etc), or contribute to reasonable travel costs from further.
Currently (Jan 2021) we do not recommend getting public transport – please get in touch to discuss options for taxis and driving to Oxford.
Yes! Just keep your receipts or copies/pictures of them.
....even if I live outside of Oxford?
Yes! We can cover basic travel expenses for nearby cities (Reading, London, Birmingham etc), or contribute to reasonable travel costs from further.
Currently (Jan 2021) we do not recommend getting public transport – please get in touch to discuss options for taxis and driving to Oxford.
How long will it take for me to receive my reimbursement?
Reimbursements are done via bank transfer through the University finance department and take 2-4 weeks. We typically reimburse for all visits and travel once you have completed the final visit – however, let us know if you would like us to split the reimbursement up.
Reimbursements are done via bank transfer through the University finance department and take 2-4 weeks. We typically reimburse for all visits and travel once you have completed the final visit – however, let us know if you would like us to split the reimbursement up.
How do I find you?
Our visits all occur at either the Clinical Research Facility or the Neurosciences building, located on the Warneford Hospital site in Oxford.
The Clinical Research Facility [google map link] is to the left of the main Warneford hospital reception. See map below!
The Neurosciences building [google map link] is near the back car-park for the Warneford hospital.
If you are unclear where to go on the day, ring your researcher and they can meet you outside the Warneford hospital reception.
Our visits all occur at either the Clinical Research Facility or the Neurosciences building, located on the Warneford Hospital site in Oxford.
The Clinical Research Facility [google map link] is to the left of the main Warneford hospital reception. See map below!
The Neurosciences building [google map link] is near the back car-park for the Warneford hospital.
If you are unclear where to go on the day, ring your researcher and they can meet you outside the Warneford hospital reception.
Is there parking?
There is limited parking with pay and display. We will reimburse your parking.
There is limited parking with pay and display. We will reimburse your parking.
Which buses can I get to the Warneford?
The 4A, 4B and 4C all stop near the Warneford – though currently we do not advise you taking public transport to attend visits.
The 4A, 4B and 4C all stop near the Warneford – though currently we do not advise you taking public transport to attend visits.