Nortriptyline :: Multiple pharmacies comparison.

Jorge RE, Robinson RG, Arndt S, Starkstein S. Mortality and poststroke depression: a placebo controlled trial of anti-depressants. Am J Psychiatry 2003; 160:1823-1829.
* PRACTICE RECOMMENDATIONS
Treatment with either fluoxetine or nortriptyline for 12 weeks during the first 6 months poststroke reduced the mortality risk of both depressed and nondepressed patients. Strong consideration should be given to treating clinically depressed and nondepressed poststroke patients who are at significant risk of developing depression (family history or personal history of mood disorders) with antidepressant medication.
* BACKGROUND

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CLOBETASOL.(Taro Pharmaceuticals USA receives FDA approval)(Brief Article)

Depression commonly occurs after an acute stroke and is associated with an increased risk of poststroke mortality. It is uncertain to what extent antidepressant treatment reduces this risk.
* POPULATION STUDIED
This study enrolled 104 patients between the ages of 26 to 89 years (mean, 69 years) with an acute stroke within the previous 6 months. Patients were excluded ff they had any other significant medical illness that would threaten survival or recovery from a stroke, severe comprehension deficit that precluded a verbal interview, history of head injury, or history of brain injury or disease other than a prior stroke.
* STUDY DESIGN AND VALIDITY
Patients were randomly assigned (uncertain allocation concealment) to receive fluoxetine, nortriptyline, or placebo unless specific contraindications were present. Fluoxetine was contraindicated for patients with an intracerebral hemorrhage; nortriptyline was contraindicated for patients with a cardiac conduction abnormality or a myocardial infarction within 3 months of the study.
Fluoxetine was given 10 mg/d for weeks 1 to 3, 20 mg/d for weeks 4 to 6, 30 mg/d for weeks 7 to 9, and 40 mg/d for the final 3 weeks. Nortriptyline was given 25 mg/d for week 1, 50 mg/d for weeks 2 and 3, 75 mg/d for weeks 4 to 6, and 100 mg/d for the final 6 weeks. Depression was defined by Diagnostic and Statistical Manual of Mental Disorders, 4th ed (DSM-IV) criteria for major depressive disorders or minor depressive disorders with a Hamilton depression score of 12 or greater.
Strengths of the study include that it used intention-to-treat analysis, doses of antidepressants were reflective of current practice, outcomes were assessed by individuals blind to treatment group assignment, and all groups were appropriately treated with proper poststroke medical management. Weaknesses of this study included a small sample size, the development subsequent to the study of new treatments for acute stroke such as intravenous and intra-arterial thrombolytics, and no psychiatric follow up beyond the first 2 years poststroke. Results are applicable to the management of poststroke patients seen in a family physician practice. (Level of evidence: 1b–)
* OUTCOMES MEASURED
The primary outcome measured was all-cause mortality.
* RESULTS
Baseline differences between the groups were minimal: significantly more men were assigned to the fluoxetine group and more women and patients with hemorrhagic stroke assigned to the nortriptyline group.
After 9 years, a total of 50 (48.1%) of the 104 patients had died. Subjects assigned to anti-depressants were significantly more likely to be alive compared with those receiving placebo (59.2% vs 36.4%; P=.03; NNT=4). There were no significant differences in risk factors for cardiovascular disease and concurrent physical illnesses except for diabetes between patients who were still alive and those who had died. Of the 104 patients enrolled, 23 (22%) dropped out before completing the 12week treatment protocol, with a statistically higher dropout rate (33%) in the fluoxetine group.
There was no significant association between depression at baseline and long-term mortality: 50% of the patients who died were diagnosed with depression at baseline, compared with 57.4% who survived. No difference was seen in survival between the patients assigned to fluoxetine or nortriptyline. Logistic regression model analysis demonstrated that the benefit of antidepressants were significant after controlling for other comorbidities.
David S. Chun, PharmD, St. Louis College of Pharmacy, St. Louis, Mo. E-mail: dchun@stlcop.edu.
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