A multi-centre randomised controlled trial of the clinical and cost-effectiveness of sertraline in preventing depression in adults following a traumatic brain injury. (STOP-D)

Research summary

BACKGROUND Traumatic brain injury (TBI) is a disruption in the normal function of the brain caused by an external force. It is one of the most common presentations in Accident and Emergency (A&E) departments,especially in young males and older people. The prevalence rates of post TBI depression (PTD) is on average 10 times higher than the general population,and this risk emerges very soon after the injury. PTD is associated with higher rates of disability,unemployment and premature mortality,including suicide. Those most at risk of PTD are more likely to be older,to be diagnosed with a mild TBI,and have a history of depression. Yet depression is not routinely screened for at TBI presentation,and rarely treated optimally. Our patient participation group have highlighted the lack of medical attention paid to mental health issues and that many neuropsychiatric symptoms are overlooked. Preliminary findings from 2 small randomised controlled trials (RCT) suggest that initiation of a selective serotonin reuptake inhibitor (SSRI) within a few weeks of the TBI could significantly reduce the incidence of PTD. AIMS We aim to build on this evidence by testing the primary hypothesis that in patients with TBI,sertraline 100mg once a day (od) prescribed for 12 months is more effective,and more cost effective,than placebo in reducing i) depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) and ii) incident rate of major depressive disorder (MDD) as measured by the Structured Clinical Interview for DSM-5 (SCID),at 12 months from baseline,with interim measures at 6 and 18 months. We will also measure secondary outcomes of quality of life,employment and productivity,carer burden,other neuropsychiatric symptoms and cognitive functioning. We will seek consent for follow up over 10 years and for hospital episodes statistics (HES) data.

Principal Investigator

Dr Vanessa Raymont

Contact us

Email: sally.beer@ouh.nhs.uk

IRAS number

1004930