Sertraline for Preventing Mood Disorders Following Traumatic Brain Injury: A Randomized Clinical Trial.
OBJECTIVE
Prevention is more effective than treatment to decrease the burden of significant medical conditions such as depressive disorders, a major cause of disability worldwide. Traumatic brain injury (TBI) is a candidate for selective strategies to prevent depression given the incidence, prevalence, and functional effect of depression that occurs after TBI.


OBJECTIVE
To assess the efficacy of sertraline treatment in preventing depressive disorders following TBI.


METHODS
A double-blind, placebo-controlled, parallel-group randomized clinical trial was conducted at a university hospital from July 3, 2008, to September 17, 2012, with 24 weeks of follow-up. A consecutive sample of 534 patients aged 18 to 85 years, hospitalized for mild, moderate, or severe TBI, was eligible for the study. Ninety-four patients consented to participate and were randomized (46 to placebo and 48 to sertraline), of whom 79 (84%) completed the study. Intention-to-treat data analysis was conducted from July 1, 2014, to December 31, 2015.


METHODS
Placebo or sertraline, 100 mg/d, for 24 weeks or until development of a mood disorder.


METHODS
Time to onset of depressive disorders, as defined by the DSM-IV, associated with TBI.


RESULTS
Of the 94 patients in the study (38 female and 56 male; 92 white), the number needed to treat to prevent depression after TBI at 24 weeks was 5.9 (95% CI, 3.1-71.1; χ2 = 4.6; P = .03) for sertraline treatment vs placebo. The influence of sertraline in the course of neuropsychological variables was not detected. The intervention was well tolerated, and adverse effects were mild in both the sertraline and placebo groups.


CONCLUSIONS
Sertraline appears to be efficacious to prevent the onset of depressive disorders following TBI. Future studies should replicate these findings in a large sample of patients with TBI and depict their long-term physical, cognitive, behavioral, and functional outcomes.


BACKGROUND
clinicaltrials.gov Identifier: NCT00704379.
Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.
Ricardo E
RE
Jorge
Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas2Iowa Consortium for Substance Abuse Research and Evaluation, University of Iowa, Iowa City3Instituto de Cálculo, Facultad de Ciencias Exactas y Naturales, Universidad de Buenos Aires-Consejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, Argentina.
Laura
L
Acion
Facultad de Psicología, Universidad de Buenos Aires-Consejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, Argentina.
Debora I
DI
Burin
Department of Psychiatry, University of Iowa, Iowa City.
Robert G
RG
Robinson
D000328:Adult; D000368:Aged; D000070642:Brain Injuries, Traumatic / Q000150:complications* / Q000401:mortality* / Q000523:psychology; D003430:Cross-Sectional Studies; D003718:Denmark; D003866:Depressive Disorder / Q000175:diagnosis / Q000401:mortality* / Q000517:prevention & control* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006785:Hospitals, University; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D012042:Registries; D020280:Sertraline / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D020280:Sertraline