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Original Investigation |

Sertraline for Preventing Mood Disorders Following Traumatic Brain Injury A Randomized Clinical Trial ONLINE FIRST

Ricardo E. Jorge, MD1; Laura Acion, PhD1,2,3; Debora I. Burin, PhD4; Robert G. Robinson, MD5
[+] Author Affiliations
1Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas
2Iowa Consortium for Substance Abuse Research and Evaluation, University of Iowa, Iowa City
3Instituto de Cálculo, Facultad de Ciencias Exactas y Naturales, Universidad de Buenos Aires–Consejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, Argentina
4Facultad de Psicología, Universidad de Buenos Aires–Consejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, Argentina
5Department of Psychiatry, University of Iowa, Iowa City
JAMA Psychiatry. Published online September 14, 2016. doi:10.1001/jamapsychiatry.2016.2189
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Importance  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.

Design, Setting, and Participants  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.

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

Main Outcomes and Measures  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 and Relevance  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.

Trial Registration  clinicaltrials.gov Identifier: NCT00704379

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Figure 1.
CONSORT Diagram
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Figure 2.
Risk Comparison of Onset of Mood Disorder for Patients Receiving Sertraline or Placebo

Tick marks show censored observations. NNT indicates number needed to treat; NNTB, number needed to treat to benefit; and NNTH, number needed to treat to harm.

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