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

King's College Hospital0 sites514 target enrollmentDecember 23, 2022

ConditionsDepressive disorder after traumatic brain injury Mental and Behavioural Disorders

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Depressive disorder after traumatic brain injury
Sponsor: King's College Hospital
Enrollment: 514
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 23, 2022

End Date

April 30, 2025

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

King's College Hospital

Eligibility Criteria

Inclusion Criteria

•Participant inclusion criteria as of 29/04/2024:
•1\. Adults aged 18 years and above
•2\. UK residents
•3\. 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
•4\. No current major depressive disorder as measured by the Structured Clinical Interview (SCID)
•Previous participant inclusion criteria:
•1\. Adults aged 18 years and above
•2\. UK residents
•3\. Mild or moderate\-severe TBI that occurred less than 4 weeks before time of consent defined as probable and definite TBIs by the Mayo Classification System
•4\. No current major depressive disorder as measured by the Structured Clinical Interview (SCID)

Exclusion Criteria

•Participant exclusion criteria as of 29/04/2024:
•1\. Concurrent antidepressant medication at the British National Formulary recommended therapeutic doses for the treatment of depression
•2\. Other causes of acquired brain injury such as stroke
•3\. 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
•4\. Pregnant or planning pregnancy
•5\. 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\. Lactating