Antidepressant Advisor Study (ADeSS)
What is the study about?
For many people with depression, the antidepressants most usually prescribed by GPs are only somewhat helpful. There is an urgent need to improve the treatment of depression by providing better advice about the choices of antidepressant medications available.
What would you have to do?
Study 1 – Recruitment exclusively via selected GP surgeries
This study will test whether tailored recommendations for specific other antidepressants can be helpful to GPs and have the potential to improve depression. These recommendations will be delivered by an Antidepressant Advisor tool which we have developed for this purpose. The tool is integrated into the GP’s existing computer software.
Study 2 – Recruitment via this website
The aim of this research project is to better predict who will benefit from a specific treatment of depression using information collected via a mobile app and to determine whether the mobile app is helpful for people with mood disorders (study 2).
If you are interested in taking part in the study, we would invite you to use our Antidepressant Advisor app either on an Android or Apple mobile device, or your PC for 16 weeks. The app asks you about your depression, self-blame, side effects, and symptoms of a high in mood (weekly, 10-15 min), as well as medication (daily, 1 min).
2) at least moderately severe major depressive syndrome on PHQ-9 (score≥15)
3) able to complete self-report scales orally or in writing
4) early treatment resistance as defined by 1) current or recent prescription (in the last 2 months) of any of the following antidepressants listed: citalopram, fluoxetine, sertraline, escitalopram, paroxetine, venlafaxine, or duloxetine, AND 2) previous prescription of at least one other antidepressant out of the same list of antidepressants.
1) inability to consent to the study
2) unstable medical condition
3) past diagnosis of schizophrenia or schizo-affective disorder
4) current psychotic symptoms
5) bipolar disorder
6) drug (modified PHQ) or alcohol abuse (PHQ) over the last 6 months
7) suspected central neurological condition
What are the benefits?
Although, we hope that using our app will be helpful in monitoring your depression and medication, there are no documented direct benefits to you. By helping to find better ways to predict who will benefit from a specific antidepressant, it is you who will benefit the progress of research and thereby other people with depression in the future.
What are the possible disadvantages?
Some of the questions used require you to think about unpleasant emotions. This may evoke feelings such as guilt or anger. In case you feel distressed during or after taking part in the study, please tell the research team who will contact Dr Zahn or another psychiatrist/psychologist involved in the research project to arrange for further counselling over the phone.
If you would like to see if you are eligible to take part, click here to complete the online pre-assessment. Alternatively, contact us on the contact details below if you would like a pre-assessment to be conducted by phone or letter.
Study 3 – Recruitment via selected GP surgeries & this website
The aim of this study is to find better ways to predict how well a treatment works for a particular person (i.e. predicts response to treatment). We have previously found some psychological tests, brain scans, and blood tests that could be useful in predicting response to treatment. So far, no one has combined these to see whether they could be practically useful in the NHS.
What will I be asked to do?
- If you are interested in taking part in the study, and an initial phone screening or electronic questionnaire has indicated that we may include you, we would then invite you to attend the first session at King’s College London. During this first session, you will be asked to take part in an evaluation of your mental health, which includes questions and some computer tests. If you are taking part in the Antidepressant Advisor Trial (study 1), then this first session will not be necessary.
- If the evaluation of your mental health confirms the results of the conclusions we reached during our screening, we will invite you to further participate in the study. Further participation in the study will mean that you will be invited to take part in a magnetic resonance imaging (MRI) session. We will also ask you to use a mobile app to track your depression and medication. For participants of the Antidepressant Advisor Trial (study 1) this is already included in the study.
- On the day of the MRI you will perform practice tasks prior to the MRI. This preparation may take up to 45 min. The MRI session will take 30 min to one hour. The actual time, however, you are in the scanner may be longer than this if there are any technical difficulties and so it may take up to 90 minutes to complete one session.
- After you have changed your treatment for depression, we will schedule a final assessment similar to your first where we evaluate your mental health. This part of the study will last about 3 hours. For participants of the Antidepressant Advisor Trial (study 1) this is already included in the study and can take part in their GP surgery or in their own homes.
The imaging is done on a standard clinical scanning machine called a Magnetic Resonance Imaging (MRI) Scanner (3 Tesla). There is no ionising radiation (x-rays) involved in this type of scan and if all precautions are taken, there are no known risks. You will be asked to fill in a Safety Questionnaire that asks about the presence of any metal in or on the body before you enter the MRI scanning room. If you are a woman of childbearing age, you need to be sure that you are not pregnant as those who are pregnant cannot undergo a research MRI scan. Magnetic Resonance Imaging uses a strong magnetic field to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, you will be asked to lie on a table that can slide in and out of the cylinder. While in the scanner you will hear loud knocking noises, and you will wear earplugs to muffle the sound. You will be able to communicate with the MRI scanning staff at all times during the scan. We will move you out of the machine anytime that you wish.
What are the possible benefits of taking part?
There are no documented direct benefits for you. It is you who will benefit the progress of medical research. You make an important contribution to a better understanding of depression and its treatment by taking part in our research project. We will write a short report on the results of the diagnostic interviews, which we have carried out, to you and your GP/responsible clinician. A limited assessment of the MRI scans will be performed by a neuroradiologist and identification of a major abnormality that requires action will be reported to the GP you specify on your MRI consent form. You will also receive an electronic copy of your MRI scan if you wish.
Risks/Discomforts of MRI
You will be at risk of injury from the MRI magnet if you have a pacemaker or other implanted electrical devices fitted, or if you have a brain stimulator, dental implant, aneurysm clip(s) (metal clip(s) on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear [ear] implants), implanted delivery pump, or shrapnel fragments. Welders and metal workers are also at risk of injury because of the potential for small metal fragments to be embedded in the eye of which you may be unaware. For this reason, if you have any of these conditions, you will not receive an MRI scan. If you have a question about any metal objects being present in the body, you should inform the researcher. In addition, all magnetic objects (for example, watches, coins, jewellery, and credit cards) must be removed before entering the MRI scan room. Women who are pregnant may not undergo a research MRI. Individuals with fear of confined spaces may become anxious during an MRI and will not be suitable. There are no known long-term risks or consequences of MRI scans. We will ask you to think about guilt and anger during the MRI scan and this may be upsetting for some people.
If you would like to see if you are eligible to take part, click here to complete the online pre-assessment.
Watch Dr Roland Zahn being interviewed on ITV
Please contact either of us at the address below if you have any questions about the study.
Dr Phillippa Harrison (Trial Co-ordinator)
Project e-mail: email@example.com
Dr Roland Zahn (Chief Investigator)