Eligibility

Local study conflicts

• None

Inclusion Criteria:

• Adults aged 18 years old and above
• UK resident
• Possible, mild or moderate-severe TBI that occurred less than 8 weeks before time of consent defined as possible, probable and definite TBIs by the Mayo Classification System (MYS) [59]
• No current major depressive disorder

Exclusion Criteria:

• Concurrent antidepressant medication at British National Formulary (BNF) recommended therapeutic doses for treatment of depression
• Other causes of acquired brain injury such as stroke
• Known psychotic or bipolar disorders (except for mild cognitive impairment), known dementia (except for mild), actively suicidal, other acute or chronic neurological conditions except post-traumatic epilepsy, terminal or advanced medical illness such as end stage kidney failure, heart failure, severe hepatic impairment
• Pregnant or planning pregnancy
• Women of childbearing age (WCBA) unless acceptable effective methods of contraception are being used
  
  
  • Female subjects must agree to one of the following during the duration of the study:
  • Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable method of contraception only when it is in line with the subject’s preferred and usual lifestyle.
  • Consistent and correct use of 1 of the following methods of birth control: a) intrauterine device (IUD) with a failure rate of <1% per year; b) tubal sterilization; c) vasectomy in the male partner; d) hormonal methods (oral contraceptives, injectable progesterone, implants of levonorgestrel, transdermal contraceptive patch, contraceptive vaginal ring). In case of essure micro-insert system, this will need to be used in association with another method of contraception; Male subjects with female partners of childbearing potential must use condoms during the trial.
• Lactating
• Medical causes of depression such as pituitary failure
• Known allergy to sertraline
• Current hyponatraemia (sodium < 135 mmol/L based on discussion with the local PI or their treating physician to confirm it is safe for the patient to be enrolled)
• Taking medications absolutely contraindicated with sertraline as stated in the SmPC
• Participating in another Clinical Trial of an Investigational Medicinal Product (CTIMP) study or participated ≤ 30 days from consent
• Participants will be excluded if they are not able to complete self-administered questionnaires in English. (English proficiency in comatose patients will be assessed through next of kin and to the best of the ability of the clinician with the available information. Participants who come out of a coma will be reassessed for eligibility regarding English proficiency criterion. If non-proficient in English, they will be withdrawn)

If the patient is eligible:

• Gain verbal agreement in principle before proceeding. Explain that they may be eligible to enter a research study seeking to improve the care of patients with their condition:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Friday 07:30 – 18:30


• Contact the EMROx research team on:
  Mobile 0776818242
  Tel 01865 222003
  Bleep 6680

Out of hours and weekends:

Awaiting details