Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial
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, prevale...
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| Acceso en línea: | http://hdl.handle.net/20.500.12110/paper_2168622X_v73_n10_p1041_Jorge |
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todo:paper_2168622X_v73_n10_p1041_Jorge2023-10-03T16:39:41Z Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial Jorge, R.E. Acion, L. Burin, D.I. Robinson, R.G. placebo sertraline sertraline adult aged Article controlled study depression diarrhea dizziness double blind procedure fatigue female follow up human injury severity insomnia major clinical study male mood disorder nausea neuropsychological test physiotherapy randomized controlled trial side effect sweating traumatic brain injury xerostomia complication cross-sectional study Denmark Depressive Disorder intention to treat analysis middle aged mortality psychology register traumatic brain injury treatment outcome university hospital young adult Adult Aged Brain Injuries, Traumatic Cross-Sectional Studies Denmark Depressive Disorder Double-Blind Method Female Follow-Up Studies Hospitals, University Humans Intention to Treat Analysis Male Middle Aged Registries Sertraline Treatment Outcome Young Adult 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, 100mg/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; x2 = 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. Copyright 2016 American Medical Association. All rights reserved. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_2168622X_v73_n10_p1041_Jorge |
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Universidad de Buenos Aires |
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I-28 |
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R-134 |
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Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) |
| topic |
placebo sertraline sertraline adult aged Article controlled study depression diarrhea dizziness double blind procedure fatigue female follow up human injury severity insomnia major clinical study male mood disorder nausea neuropsychological test physiotherapy randomized controlled trial side effect sweating traumatic brain injury xerostomia complication cross-sectional study Denmark Depressive Disorder intention to treat analysis middle aged mortality psychology register traumatic brain injury treatment outcome university hospital young adult Adult Aged Brain Injuries, Traumatic Cross-Sectional Studies Denmark Depressive Disorder Double-Blind Method Female Follow-Up Studies Hospitals, University Humans Intention to Treat Analysis Male Middle Aged Registries Sertraline Treatment Outcome Young Adult |
| spellingShingle |
placebo sertraline sertraline adult aged Article controlled study depression diarrhea dizziness double blind procedure fatigue female follow up human injury severity insomnia major clinical study male mood disorder nausea neuropsychological test physiotherapy randomized controlled trial side effect sweating traumatic brain injury xerostomia complication cross-sectional study Denmark Depressive Disorder intention to treat analysis middle aged mortality psychology register traumatic brain injury treatment outcome university hospital young adult Adult Aged Brain Injuries, Traumatic Cross-Sectional Studies Denmark Depressive Disorder Double-Blind Method Female Follow-Up Studies Hospitals, University Humans Intention to Treat Analysis Male Middle Aged Registries Sertraline Treatment Outcome Young Adult Jorge, R.E. Acion, L. Burin, D.I. Robinson, R.G. Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| topic_facet |
placebo sertraline sertraline adult aged Article controlled study depression diarrhea dizziness double blind procedure fatigue female follow up human injury severity insomnia major clinical study male mood disorder nausea neuropsychological test physiotherapy randomized controlled trial side effect sweating traumatic brain injury xerostomia complication cross-sectional study Denmark Depressive Disorder intention to treat analysis middle aged mortality psychology register traumatic brain injury treatment outcome university hospital young adult Adult Aged Brain Injuries, Traumatic Cross-Sectional Studies Denmark Depressive Disorder Double-Blind Method Female Follow-Up Studies Hospitals, University Humans Intention to Treat Analysis Male Middle Aged Registries Sertraline Treatment Outcome Young Adult |
| description |
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, 100mg/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; x2 = 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. Copyright 2016 American Medical Association. All rights reserved. |
| format |
JOUR |
| author |
Jorge, R.E. Acion, L. Burin, D.I. Robinson, R.G. |
| author_facet |
Jorge, R.E. Acion, L. Burin, D.I. Robinson, R.G. |
| author_sort |
Jorge, R.E. |
| title |
Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| title_short |
Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| title_full |
Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| title_fullStr |
Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| title_full_unstemmed |
Sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| title_sort |
sertraline for preventing mood disorders following traumatic brain injury a randomized clinical trial |
| url |
http://hdl.handle.net/20.500.12110/paper_2168622X_v73_n10_p1041_Jorge |
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