Ashman et al.

(2009)

USA

RCT

PEDro=10

N=41

Population: TBI; Mean Age=49.1 yr; Gender: Male=24, Female=17; Severity of Injury: Mild=15, Moderate=16, Severe=10; Mean Time Post Injury=17.7 mo.

Treatment: The treatment group (n=22) was given sertraline (25 mg adjusted every 2 wk, range 25-100 mg) and the control group (n=19) received a placebo for 10wk.

Outcome Measure: Structured Clinical Interview for DSM-IV Axis I Disorders, Hamilton Rating Scale for Depression (HAM-D), Beck Anxiety Inventory (BAI), and Life-3 scale (QOL).

1.        Treatment responders, based on HAM-D (score <10 or decreased by 50%) were 59% in the treatment group and 32% in the control (p=0.08).

2.        Changes in scores on the HAM-D, the BAI and the QOL scales did show improvement (p<0.001) but no group effects were found.

Lee et al.

(2005)

Korea

RCT

PEDro=8

N=30

Population: TBI; Gender: Male=24, Female=6; Group A: N=10; Mean Age=35.3 yr; Mean Time Post Injury=34.8 days. Group B: N=10; Mean Age=33.6 yr; Mean Time Post Injury=31.9 days. Group C: N=10; Mean Age=35.5 yr; Time Post Injury=30 days.

Treatment: Patients assigned to one of three groups: Group A: methylphenidate (5 mg/day increased to 20 mg/day); Group B: sertraline group (25 mg/day increased to 100 mg/day); or Group C: placebo.

Outcome Measure: Beck Depression Inventory (BDI) and the Hamilton Rating Scale for Depression (HAM-D).

1.        In all 3 groups scores on the HAM-D and BDI improved from the baseline and week 4 (Group A, p<0.001 on both measures; Group B, p<0.01, for both; Group C, p<0.05 BDI and p<0.01 for HAM-D).

2.        Groups A (p=0.005) and B (p=0.05) were significantly superior to Group C on the HAM-D.

3.        The number of adverse events was higher in Group B than Group A (13 versus 6, p=0.010).