Sertraline for major depression during the year following traumatic brain injury: A randomized controlled trial

Model System:

TBI

Reference Type:

Journal article

Accession No.:

J77069

Journal:

Journal of Head Trauma Rehabilitation

Year, Volume, Issue, Page(s):

2017 , 32, 5, 332-342

Publication Website:

Abstract:

This randomized controlled trial examined the efficacy and tolerability of sertraline compared with placebo for the treatment of major depressive disorder (MDD) within 1 year of sustaining a complicated mild-to-severe traumatic brain injury (TBI). Study medication (identical-appearing sertraline or inert placebo) was administered per a flexible-dose algorithm. Study assessments and dosage titrations occurred at baseline and 1, 3, 6, 8, 10, and 12 weeks. The primary depression outcome was the 17-item Hamilton Depression Rating Scale. Symptom improvement and remission were also assessed. Sixty-two participants were randomized. Of those, 21 participants (68 percent) assigned to the sertraline group completed the medication protocol compared with 28 (90 percent) in the placebo group. Depression significantly improved from baseline to 12 weeks in both treatment groups. There were no significant differences between the sertraline and placebo groups over 12 weeks on depression severity, response, or remission. The sertraline group had significant improvement on speed of information processing compared with the placebo group. Findings indicate sertraline monotherapy was not superior to placebo for MDD in people with post–acute complicated mild-to-severe TBI. Research is needed on the effectiveness of interventions that also address the significant psychosocial needs of this population.

Author(s):