Advert shared on behalf of researchers at King’s College London.
Are you…?
Diagnosed with a traumatic brain injury (TBI)
Aged 18 and over
Interested in being part of valuable research
We are carrying out a clinical trial of Sertraline (an effective and widely used drug treatment for depression) among people who are not currently experiencing depression following a head injury (TBI), to see if it helps long term to prevent them from getting depressed.
Unfortunately, many people who suffer from a head injury (also called a 'traumatic brain injury, or 'TBI' for short) experience episodes of low mood (also called depression). Depression after a head injury is very common and is often caused by many factors. These can include underlying brain damage, other health problems and the consequences of the injury such as financial or social changes.
Both drug and non-drug treatments are used to manage depression in people after a head injury, but preventing the depression from happening at all would be much better and easier. One drug that has shown to be effective in treating depression after a head injury is the anti-depressant sertraline (widely used). However, there is currently insufficient information to know how effective sertraline is for preventing depression after head injury in the first place.
We are carrying out a clinical trial of sertraline among people who are not currently experiencing depression following a head injury (TBI), to see if it helps long term to prevent them from getting depressed.
If entered into the study, you will be randomly assigned by a computer program to receive either sertraline or placebo (a dummy capsule) added to any treatment that you are already receiving. The placebo capsules look exactly like the sertraline capsules but do not contain any medication. You would be asked to take the study medication once a day for just over 12 months.
At the beginning of the study (so-called Baseline), we will complete questionnaires with you to help us understand your mood, memory, health, and the way you feel about your life and health and take routine
blood to check you don’t have any health problems that would stop you taking sertraline (especially sodium levels). We will ask about your social life and activity in the community. We may also look at your clinical records to add to our knowledge. We will also take some extra blood (3-4 tablespoons) and saliva samples to look for any changes in proteins (biomarkers) that could help us predict whether head injury causes any long-term health problems. This visit will take approximately 90 minutes.
Follow up appointments will be carried out at 2,4, 12 weeks and 6, 12 and 18 months.
The study is led by Professor Khalida Ismail at Kings College London and Dr Vanessa Raymont at Oxford University. The study is being sponsored by King’s College Hospital NHS Foundation Trust and King’s College London
The STOP-D study has been featured on BBC news and radio- you can read about it here: www.bbc.co.uk/news/health-68557769
If you are interested please email us at STOP-D@kcl.ac.uk.
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