PTOTSLPRCTThe Journal of head trauma rehabilitation2017

Sertraline for Major Depression During the Year Following Traumatic Brain Injury: A Randomized Controlled Trial.

Jesse R Fann, Charles H Bombardier, Nancy Temkin and 4 others

PMID 28520672

WHAT IT FOUND

Sertraline did not improve depression scores more than placebo over 12 weeks after traumatic brain injury.

Both groups got better. The only group difference was better information processing speed on a cognitive test for sertraline.

Key findings

01Both groups improved on depression scores over 12 weeks, but sertraline was not better than placebo on response, remission, or depression scores.

02The only significant secondary group difference was better Trail Making Test B performance in the sertraline group, improving from 92.3 seconds to 76.3 seconds, while placebo worsened from 83.0 seconds to 97.9 seconds.

03In the sertraline group, 21 participants completed the medication protocol and 55% reached at least 100 mg/day, compared with 28 participants and 74% in the placebo group; no serious adverse events occurred.

STILL TO COME

How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs

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What it does not show

The trial randomized 62 participants at one site, and only 234 of 408 screened completed baseline assessments. Many eligible people did not consent or were excluded, and the sample had limited sociodemographic diversity. Most participants were non-Hispanic White, and many had prior depression, substance dependence, or current anxiety. Uncomplicated mild traumatic brain injury was not enrolled. Participants were asked to avoid other depression medication or psychotherapy, so this does not reflect combined treatment. Study drug discontinuation was higher in the sertraline group, and fewer reached 100 mg/day. The HAM-D may have suboptimal responsiveness to change in people with traumatic brain injury, which could bias results toward null.

Declared interests

No other conflicts of interest were reported. The article is indexed as NIH extramural research support.

The easy way to misread this

Do not conclude sertraline is an effective antidepressant for depression after traumatic brain injury. The primary depression outcome did not differ from placebo, and the positive cognitive finding was a secondary measure in a small single-site trial.

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