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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Jurate
Wall
+44 (0)207 848 5785
jurate.wall@kcl.ac.uk
Ms
Rebecca Ann Marie
Murtagh
+44 020 71885732
QM.KHPCTO@kcl.ac.uk
Prof
Khalida
Ismail
+44 (0)207 848 5131 ext 0000
Khalida.2.ismail@kcl.ac.uk
Depressive disorder after traumatic brain injury
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Depression is very common following a traumatic brain injury (TBI), 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. The idea that antidepressants given early could stop depression in the first place after a traumatic brain injury was appealing. They said they would want to be given everything for the best chance of recovery. The aim of this study is to find out if a commonly used antidepressant called sertraline is better at preventing depression than a placebo (also called a dummy or ‘fake’ pill). The researchers will also want to study if sertraline improves quality of life, improve other symptoms like headaches, irritability, memory loss, and reduces stress for carers.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Participant exclusion criteria as of 29/04/2024:1. Concurrent antidepressant medication at the British National Formulary recommended therapeutic doses for the treatment of depression2. Other causes of acquired brain injury such as stroke3. 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 impairment4. Pregnant or planning pregnancy5. Women of childbearing potential if they are not using acceptable effective methods of contraception as defined by the Clinical Trials Facilitation Group (CTFG) (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.)Female subjects must agree to one of the following during the duration of the study:5.1. 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.5.2. 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 the case of the 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.6. Lactating7. Medical causes of depression such as pituitary failure8. Known allergy to sertraline9. Current hyponatraemia (if participant’s sodium is <135 mmol/L it will be discussed with the site PI or their treating physician to confirm it is safe for the patient to be enrolled)10. Taking medications contraindicated with sertraline as stated in the SmPC including concomitant treatment with irreversible monoamine oxidase inhibitors and pimozide11. Participating in another CTIMP study or participated <=30 days from consent12. 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.)
Previous participant exclusion criteria:1. Possible TBI according to the Mayo Classification System2. Concurrent antidepressant medication at British National Formulary recommended therapeutic doses for treatment of depression3. Other causes of acquired brain injury such as stroke4. Known psychotic or bipolar disorders, known dementia, actively suicidal, other acute or chronic neurological conditions except for post-traumatic epilepsy, terminal or advanced medical illness such as end-stage kidney failure, heart failure, severe hepatic impairment5. Pregnant or planning pregnancy 6. Women of childbearing potential if they are not using acceptable effective methods of contraception as defined by the Clinical Trials Facilitation Group (CTFG) 7. Lactating8. Medical causes of depression such as pituitary failure9. Known allergy to sertraline10. Current hyponatraemia (if the participant’s sodium is <130 mmol/l it will be discussed with a local hospital endocrinologist to confirm it is safe for the patient to be enrolled) 11. Taking medications contraindicated with sertraline as stated in the SmPC including concomitant treatment with irreversible monoamine oxidase inhibitors and pimozide12. Participating in another CTIMP study or participated ≤30 days from consent13. Participants will be excluded if they are not able to complete self-administered questionnaires in English
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Jurate
Wall
+44 (0)207 848 5785
jurate.wall@kcl.ac.uk
Prof
Khalida
Ismail
+44 (0)207 848 5131 ext 0000
Khalida.2.ismail@kcl.ac.uk
Ms
Rebecca Ann Marie
Murtagh
+44 020 71885732
QM.KHPCTO@kcl.ac.uk
The study is sponsored by King's College Hospital; King's College London Hospital NHS Foundation Trust and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
