What is the study about?

We are carrying out a clinical trial of sertraline (a widely used drug treatment for depression) among people who have had a recent traumatic brain injury (also called a head injury) to see if it helps to prevent them from getting depressed, and other related problems such as mood swings, sleeping difficulties, concentration and memory problems.

Depression, and related problems like poor sleep and poor concentration, is very common following a traumatic brain injury. They can affect relationships, jobs, education, and unhealthy lifestyles like smoking and poor diets. Patients who have had a traumatic brain injury in the past told us that it was important to find out if antidepressants given soon after a head injury would reduce the chances of developing depression.

Who is eligible for the study?

• Are you aged 18 years or over?
• Have you had a head injury in the last 8 weeks?
• Did you visit your local Accident and Emergency department for your head injury?

How will the study work?

If you are suitable for the study, you will meet one of our team members, receive more information about the study, and be invited to give written informed consent. You will then be randomly chosen by the computer to receive either:

100mg sertraline tablet once a day

or

100mg placebo (or dummy) tablet once a day

You will be asked to take the medication ideally for 12 months. Neither you, the study team or your clinical team will be aware of which medication you are taking. This is the gold standard way of testing whether a new medication works.

What is the goal of the study?

At the end of the study, the main goal of the study is to find if those participants who were given the medication (sertraline) are less likely to develop depressive symptoms over the 12 months compared to those who took the dummy medication. We are also measuring changes in sleep, memory, concentration and quality of life.

This study is the first in the UK to test whether depression can be prevented following a traumatic brain injury. The findings from this study will help the NHS to find new ways of improving recovery following head injury.

Interested in taking part?

For further details about the study please see our Patient Information Sheet or join our free live webinar every Monday 3-3.30pm using this link.

If you would like to take part, you can contact the study team below: