Frequently Asked Questions
Click on the below frequently asked questions to find specific answers, or scroll down to browse the FAQs. For full information please read the Participant Information Sheet here. Study outline
- What’s the core aim of the study?
- Why are we doing the study?
- Is this a treatment for depression?
- Is this a clinical trial?
- What visits does the study involve, and how long do they take?
- Do I have to do anything during the 7 day period between the two research visits?
- What COVID-19 safety precautions are you taking?
- What does the MRI scan involve?
- 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?
- Will I find out if I was in the drug or placebo group?
Are you still recruiting?
Yes, definitely! We'll be recruiting until 2023, 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 still ongoing.
Yes, definitely! We'll be recruiting until 2023, 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 still ongoing.
If I'm interested, what are the next steps?
The first step is to email us at ebselen@psych.ox.ac.uk. We will answer any initial questions you have and book a short phone call with one of the researchers 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 our medic, Dr. Beata Godlewska. The assessment will be conducted in-person or remotely, using Microsoft Teams or a phone call. For healthy volunteers, the screening will be conducted by Dr Fitri Fareez Ramli.
If eligible for the study based on the medic's assessment, we will book you in for two study visits for the participants with depression or one study visit for healthy participants. 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.
For full details of study procedure, please read the Participant Information Sheet by clicking here.
The first step is to email us at ebselen@psych.ox.ac.uk. We will answer any initial questions you have and book a short phone call with one of the researchers 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 our medic, Dr. Beata Godlewska. The assessment will be conducted in-person or remotely, using Microsoft Teams or a phone call. For healthy volunteers, the screening will be conducted by Dr Fitri Fareez Ramli.
If eligible for the study based on the medic's assessment, we will book you in for two study visits for the participants with depression or one study visit for healthy participants. 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.
For full details of study procedure, please read the Participant Information Sheet by clicking here.
Study Outline
What’s the core aim of the study?
The aim of the OxIMP Study is to investigate an anti-oxidant medicine called ebselen in people with depression who are not responding to first-line treatment, psychotherapy or antidepressant medication (so-called 'treatment-resistant depression'). We want to understand if ebselen can alter the way that people react to emotional information delivered by a range of computer-based tasks. We conduct MRI scans to measure the impact of ebselen on brain chemical messengers. In order to get a better understanding of the effect of ebselen, it is important to understand the baseline differences between people with depression and healthy individuals. Patients with depression have been shown to have altered brain structure and function in some regions. The comparison between patients and healthy controls in this study allows us to examine any differences in emotional processing, brain structures and chemicals. In this study, healthy participants will not be receiving any treatment (neither ebselen nor placebo).
What’s the core aim of the study?
The aim of the OxIMP Study is to investigate an anti-oxidant medicine called ebselen in people with depression who are not responding to first-line treatment, psychotherapy or antidepressant medication (so-called 'treatment-resistant depression'). We want to understand if ebselen can alter the way that people react to emotional information delivered by a range of computer-based tasks. We conduct MRI scans to measure the impact of ebselen on brain chemical messengers. In order to get a better understanding of the effect of ebselen, it is important to understand the baseline differences between people with depression and healthy individuals. Patients with depression have been shown to have altered brain structure and function in some regions. The comparison between patients and healthy controls in this study allows us to examine any differences in emotional processing, brain structures and chemicals. In this study, healthy participants will not be receiving any treatment (neither ebselen nor placebo).
Why are we doing this study?
One effective treatment of 'treatment-resistant depression' can be adding a drug called lithium to the antidepressant medication. However, lithium has a number of problematic side effects. In order to replace lithium, we must have a better understanding of lithium's biochemical mechanism of action, so we can replicate its therapeutic effects without these side effects.
One possible way lithium may work by inhibiting an enzyme called IMPase. IMPase controls the amount of a brain chemical messenger called inositol. Our team at Oxford has shown that ebselen, in animals and healthy volunteers, also acts on IMPase and has some effects similar to lithium but with a better safety profile!
The purpose of this study is to find out if ebselen has potential antidepressant effects in people who are not being helped by antidepressant medication.
One effective treatment of 'treatment-resistant depression' can be adding a drug called lithium to the antidepressant medication. However, lithium has a number of problematic side effects. In order to replace lithium, we must have a better understanding of lithium's biochemical mechanism of action, so we can replicate its therapeutic effects without these side effects.
One possible way lithium may work by inhibiting an enzyme called IMPase. IMPase controls the amount of a brain chemical messenger called inositol. Our team at Oxford has shown that ebselen, in animals and healthy volunteers, also acts on IMPase and has some effects similar to lithium but with a better safety profile!
The purpose of this study is to find out if ebselen has potential antidepressant effects in people who are not being helped by antidepressant medication.
Is this a treatment for depression?
No – this study is not providing treatment. The OxIMP study is an experimental research study to understand how ebselen impacts inositol levels and how this drug changes the way people with depression process information. We hope to use the information gained to develop new treatments.
You will have a 50% chance of taking ebselen and a 50% chance of taking placebo, and neither you nor the researchers involved will know which group you have been assigned until the end of the study.
No – this study is not providing treatment. The OxIMP study is an experimental research study to understand how ebselen impacts inositol levels and how this drug changes the way people with depression process information. We hope to use the information gained to develop new treatments.
You will have a 50% chance of taking ebselen and a 50% chance of taking placebo, and neither you nor the researchers involved will know which group you have been assigned until the end of the study.
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.
Ebselen is a selenium-containing antioxidant medicine which has been studied in several trials in Japan as a neuroprotective treatment to help people recover from acute stroke. You cannot currently buy it as it is an experimental drug, but it has been used in several clinical trials as well as other experimental medicine studies, which means that it has been through all the safety checks that are required for new medicines.
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.
Ebselen is a selenium-containing antioxidant medicine which has been studied in several trials in Japan as a neuroprotective treatment to help people recover from acute stroke. You cannot currently buy it as it is an experimental drug, but it has been used in several clinical trials as well as other experimental medicine studies, which means that it has been through all the safety checks that are required for new medicines.
The study visits
What visits does the study involve, and how long do they take?
The study includes a screening assessment, first research visit, taking medication or placebo for 7 days, and a second research visit (for participants with depression only).
What visits does the study involve, and how long do they take?
The study includes a screening assessment, first research visit, taking medication or placebo for 7 days, and a second research visit (for participants with depression only).
1) The screening assessment with a medic typically takes around 2 hours, either in-person, on the phone or on the video call. This will cover:
- Consent & eligibility
- Safety assessments; you will be asked about your medical and psychiatric history and will be assessed if it is safe for you to have an MRI scan.
- Re-confirm eligibility & safety
- Questionnaires and computerised emotional processing tasks
- MRI scan (for participants with depression only)
- You will be randomised to a drug or placebo group. This is a double-blind study, so neither you nor the researchers will know what group you have been assigned (for participants with depression only)
- same as the first research visit (above)
- plus an optional blood sample and one additional questionnaire.
Patient Flowchart
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Healthy Participant Flowchart
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What does the MRI scan involve?
Having an MRI scan involves simply lying still inside the scanner for 45 minutes. During this time, you will be made comfortable, and you will be able to contact researchers at all times. You will not feel anything, although you will hear some quite loud noises. As some of the scans are noisy, we would give you earplugs to make this quieter for you.
Having an MRI scan involves simply lying still inside the scanner for 45 minutes. During this time, you will be made comfortable, and you will be able to contact researchers at all times. You will not feel anything, although you will hear some quite loud noises. As some of the scans are noisy, we would give you earplugs to make this quieter for you.
Do I have to do anything during the 7 day period between the two research visits?
Yes - you will need to take capsules as per our instructions. We will ask you to note down the time you took it and if you experience any side-effects.
Yes - you will need to take capsules as per our instructions. We will ask you to note down the time you took it and if you experience any side-effects.
What COVID-19 precautions have we taken to ensure your visit is safe?
Our current safety procedures when you email us. These include:
Our current safety procedures when you email us. These include:
- vaccinating all staff
- screening all participants for vulnerability and current symptoms
- completing as many procedures remotely as possible
- 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 9 am and 5 pm.
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 9 am and 5 pm.
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.
Will I find out if I was in the drug or placebo group?
At the end of the study, once all the data has been collected, you will be able to find out what group you were in.
At the end of the study, once all the data has been collected, you will be able to find out what group you were in.
Eligibility
Am I eligible to take part?
For participants with depression, you may well be eligible to take part if you are aged between 18-70, and have symptoms of depression despite having tried at least one antidepressant medication for at least 4 weeks, are physically healthy, and able to attend our visits in Oxford. A medic will need to discuss your physical and mental health history at a screening assessment to be certain. For the healthy participants, you may be eligible to take part if you are a healthy individual aged between 18-70.
Am I eligible to take part?
For participants with depression, you may well be eligible to take part if you are aged between 18-70, and have symptoms of depression despite having tried at least one antidepressant medication for at least 4 weeks, are physically healthy, and able to attend our visits in Oxford. A medic will need to discuss your physical and mental health history at a screening assessment to be certain. For the healthy participants, you may be eligible to take part if you are a healthy individual aged between 18-70.
What things would stop me from being able to take part?
You will not be able to participate in the study if you (for participants with depression only)
You will not be able to participate in the study if you (for participants with depression only)
- have, or have had previously a diagnosis of bipolar disorder, schizophrenia, or emotionally unstable personality disorder
- on any regular prescribed medication (healthy participant group) except the contraceptive pill, unless unlikely to compromise safety or affect data quality in the opinion of the Investigator;
- have taken drugs such as antipsychotics or lithium for the treatment of the current episode of depression, or recently had electroconvulsive therapy
- are currently experiencing suicidal thoughts
- are currently dependent on drugs or alcohol
- are currently pregnant, breastfeeding or planning a pregnancy
- have a Body Mass Index (BMI – kg/m2 ) below 18 and above 36
- are claustrophobic (you find the MRI scans uncomfortable)
- have metallic implants or other devices in your body that make you unsafe to go into the scanner
- have previously participated in a study using the same, or similar, emotional processing tasks in the last three months
- have participated in a research study involving the use of medication in the last three months
- have any planned medical treatment during the duration of the study that might interfere with study procedures
- have, or have had previously, a diagnosis of depression, bipolar disorder, schizophrenia, other psychiatric disorders, or emotionally unstable personality disorder
- have taken regular prescribed medications unless unlikely to compromise safety or affect data quality in the opinion of the investigator
- are currently dependent on drugs or alcohol
- are currently pregnant
- have a Body Mass Index (BMI – kg/m2) below 18 or above 36
- have previously participated in a study using the same, or similar, emotional processing tasks in the last three months
- have participated in a research study involving the use of medication in the last three months
- have any planned medical treatment during the duration of the study that might interfere with study procedures
Travel and reimbursement
How much will I be reimbursed for taking part in the study?
You will be reimbursed £100 for the participants with depression for the full study as you have more visits than the healthy participants. For healthy participants, you will be reimbursed £30 for the full study. If you only take part in the screening visit or drop out during the study, you will be reimbursed proportionately for your time in the study.
How much will I be reimbursed for taking part in the study?
You will be reimbursed £100 for the participants with depression for the full study as you have more visits than the healthy participants. For healthy participants, you will be reimbursed £30 for the full study. If you only take part in the screening visit or drop out during the study, you will be reimbursed proportionately for your time in the study.
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.
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.
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 occur at the Neurosciences building and Oxford Centre for Human Brain Activity (OHBA), located on the Warneford Hospital site in Oxford.
The Neurosciences building [google map link] is near the back car-park for the Warneford hospital.
If you are unclear about where to go on the day, ring your researcher, and they can meet you outside the Warneford hospital reception.
Our visits occur at the Neurosciences building and Oxford Centre for Human Brain Activity (OHBA), located on the Warneford Hospital site in Oxford.
The Neurosciences building [google map link] is near the back car-park for the Warneford hospital.
If you are unclear about 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 Hospital?
The 4A, 4B and 4C all stop near the Warneford Hospital.
The 4A, 4B and 4C all stop near the Warneford Hospital.
