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Table 8.1 Pharmacological Interventions for the Treatment of Depression Post ABI

Author Year

Country

Research Design

PEDro

Sample Size

 

Methods

 

Outcomes

Sertraline

Ashman et al. (2009)

USA

RCT

PEDro=10

N=41

 
Gender: Male=24, Female=17; Mean Time Post Injury=17.7mo; Injury Severity: Mild=15, Moderate=16, Severe=10. Intervention: Patients were diagnosed with major depression. The treatment group (n=22) received sertraline (25mg adjusted every 2wk, up to 100 mg) and the control (n=19) received a placebo, both for 10wk. Outcome Measure: Diagnostic and Statistical Manual of Mental Disorders (DSM), Hamilton Rating Scale for Depression (HAM-D), Beck Anxiety Inventory (BAI), 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). Changes in scores on the HAM-D, BAI, and QOL scales showed improvement (p<0.001) but no group effects were found.

Desipramine

Wroblewski et al. (1996)

USA

RCT

PEDro=4

N=10

Population: TBI; Mean Age=32.2yr; Gender: Male=7, Female=3; Mean Time Post Injury=1.5yr; Injury Severity=Severe. Intervention: Patients were diagnosed with major depression. The treatment group (n=6) received desipramine (150 mg/d for 30day, 150-300 mg/day after) and the control group (n=4) received a placebo. The control group crossed over and received desipramine after day 30.Outcome Measure: Diagnostic and Statistical Manual of Mental Disorders (DSM), Affect/Mood Scale (AMS). 1.         Three individuals from each group had nearly complete resolution of depression (DSM) on desipramine. 2.         Seventy percent of subjects showed improvement over time on the AMS. 3.         There were different rates of improvement over time in those started on the desipramine rather than placebo, with the treatment group making more rapid and greater improvements (p=0.001).
Multiple Medications Evaluated

Lee et al. (2005)

Korea

RCT

PEDro=8

N=30

 
Population: TBI; Gender: Male=24, Female=6. Group A (n=10): Mean Age=35.3yr; Mean Time Post Injury=34.8d. Group B (n=10): Mean Age=33.6yr; Mean Time Post Injury=31.9d. Group C (n=10): Mean Age=35.5yr; Time Post Injury=30d. Intervention: Patients diagnosed with major depression were assigned to one of three groups for 4wk: Group A received methylphenidate (5mg/d increased to 20mg/d); Group B received sertraline (25mg/d increased to 100mg/d); or Group C received placebo. Outcome Measure: Beck Depression Inventory (BDI), 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 significantly higher in Group B than Group A (13 versus 6, p=0.010).

Perino et al. (2001)

Italy

Pre-Post

N=20

 
Population: TBI; Gender: Male=11, Female=9. Group A (n=11): Mean Age=26.9yr; Mean GCS Score=5.5; Mean Time Post Injury=4.7 mo. Group B (n=9): Mean Age=31.3yr; Mean GCS Score=6.1; Mean Time Post Injury=34.6 mo. Intervention: Patients diagnosed with major depression received citalopram (20 mg/day) and carbamazepine (600 mg/day), and were divided into subgroups based on time post injury (Group A, <6mo; Group B, 24-36mo). Outcome Measure: Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI). 1.         Total sample significantly improved from baseline to 12wk on the BPRS (62.3±17.6 versus 51.7±12.8, p≤0.05) and CGI (4.4±1.1 versus 3.4±0.8, p≤0.005). 2.         When comparing groups, Group B had higher global scores on the BPRS at baseline and 12wk than Group A.  
PEDro=Physiotherapy Evidence Database rating scale (Moseley et al. 2002).