STOP-D (TBI Study)
Research type
Research Study
Full title
A multi-centre randomised controlled trial of the clinical and cost-effectiveness of sertraline in preventing depression in adults following a traumatic brain injury.
IRAS ID
1004930
Contact name
Khalida Ismail
Contact email
Sponsor organisation
King’s College London
Eudract number
2022-000072-18
ISRCTN Number
ISRCTN17518945
Research summary
Depression is very common following a traumatic brain injury, also called a head injury. Around 50% of people with a head injury will have some form of depression over the next 10 years. This is almost 10 times more common than the general public. There are two main symptoms of depression, a constant low mood and a loss of enjoyment in everyday life. Depression can affect relationships, jobs, education, financial hardship and unhealthy lifestyles like smoking and poor diets. People with depression following a traumatic brain injury tend to die earlier than the rest of the population and they are more likely to commit suicide.
Our patient and public involvement group (PPI) recognised the symptoms of depression and also mentioned others such as irritability, confusion, being very sensitive to noises and light. They agree that trying to prevent depression occurring in the first place is very important.
Participants will be recruited from 9 Major Trauma Centres across England and from all walks of life. Patients attending A&E with a traumatic brain injury will be given information about this study. We will wait for any immediate effects of the head injury, such as memory loss, to settle. Those patients who are suitable will be invited to consent to join the study. They will have an equal chance of receiving sertraline or placebo.
We have brought together a unique team of senior doctors and researchers for this study. At each hospital a psychiatrist will lead the research supported by either a neurologist or neurosurgeon, so that patients are safely managed in terms of mental health and physical health. We also have patient groups working with us, such as the charity, Headway. They have already given feedback on the study which helped us to improve our methods. After the study finishes, we will share our results in medical journals, in social media and to leaders of the NHS so that the prevention of depression can be included for this group of patients.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0310
Date of REC Opinion
22 Dec 2022
REC opinion
Further Information Favourable Opinion