A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury

Arch Phys Med Rehabil. 2009 May;90(5):733-40. doi: 10.1016/j.apmr.2008.11.005.


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 from preintervention to posttreatment for all 3 outcome measures (P<.001) but no group effects. Random-effects modeling did not find any significant difference in patterns of scores of the outcome measures between the placebo and medication groups.

Conclusions: Both groups showed improvements in mood, anxiety, and QOL, with 59% of the experimental group and 32% of the placebo group responding to the treatment, defined as a reduction of a person's HAM-D score by 50%.

Trial registration: ClinicalTrials.gov NCT00233103.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Antidepressive Agents / administration & dosage*
  • Brain Injuries / complications*
  • Brain Injuries / diagnosis
  • Brain Injuries / rehabilitation
  • Depressive Disorder / diagnosis
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / etiology*
  • Diagnostic and Statistical Manual of Mental Disorders
  • 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
  • Risk Assessment
  • Sertraline / administration & dosage*
  • Treatment Outcome


  • Antidepressive Agents
  • Sertraline

Associated data

  • ClinicalTrials.gov/NCT00233103