A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury
Abstract
Objective To examine the efficacy of sertraline in the treatment of depression after traumatic brain injury (TBI). Design Double-blind, randomized controlled trial. Setting Research center at a major urban medical center. Participants Subjects were a referred and volunteer sample of 52 participants with TBI, a diagnosis of major depression disorder (MDD), and a score on the Hamilton Rating Scale for Depression (HAM-D) of 18 or greater. The majority of the sample was male (58%), had less than 14 years of education (73%), had incomes below $20,000 (82%), and were from minority backgrounds (75%). Approximately one third of the sample had mild brain injuries, and two thirds had moderate to severe brain injuries. The mean age was 47+/-11, and the mean time since injury was 17+/-14 years. One participant withdrew from the study because of side effects. Intervention Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) or placebo for 10 weeks. Main outcome measures The HAM-D, the Beck Anxiety Inventory, and the Life-3 quality of life (QOL). Results No statistically significant differences were found at baseline between drug and placebo groups on baseline measures of depression (24.8+/-7.3 vs 27.7+/-7.0), anxiety (16.4+/-12.3 vs 24.0+/-14.9), or QOL (2.96+/-1.0 vs 2.9+/-0.9). The income level of those receiving placebo was significantly lower than those participants receiving medication. Analyses of covariance revealed significant changes…
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Standard pharmacological interventions such as SSRIs have failed to show efficacy for depression in the context of TBI in randomized controlled trials.
“Additionally, the standard pharmacological interventions that are often first-line treatments for depression in the general population (e.g., SSRIs) have failed to show efficacy in the context of TBI in randomized controlled trials (12, 13).”
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References 95 · Cited by 149
- Authors
- Ashman, T. A., Cantor, J. B., Gordon, W. A., Spielman, L., Flanagan, S., Ginsberg, A., Engmann, C., Egan, M., Ambrose, F., & Greenwald, B.
- Affiliations
- Icahn School of Medicine at Mount Sinai (US)
- New York University (US)
- Corresponding author
- Ashman, Teresa A.
- Venue
- Archives of Physical Medicine and Rehabilitation
- Publisher
- Elsevier BV
- Published
- 2009-05
- Volume
- 90
- Issue
- 5
- Pages
- 733-740
- ISSN
- 0003-9993 (ISSN-L)
- OpenAlex
- W1984135336
- Cited by
- 149
- References
- 95
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 5 · 2023: 3 · 2022: 7 · 2021: 4 · 2020: 9 · 2019: 16 · 2018: 12 · 2017: 7 · 2016: 12 · 2015: 14 · 2014: 6 · 2013: 10 · 2012: 7
- FWCI
- 7.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Physical Medicine and Rehabilitation (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Traumatic Brain Injury Research
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- sertraline, traumatic brain injury, major depressive disorder, antidepressant treatment, post-traumatic depression, anxiety, quality of life, placebo response
- MeSH terms
- Adult, Antidepressive Agents, Brain Injuries, Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Male, Middle Aged, Probability, Psychiatric Status Rating Scales, Quality of Life, Reference Values, Treatment Outcome, Risk Assessment, Sertraline, Diagnostic and Statistical Manual of Mental Disorders
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