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June 1, 1999American Heart Journal162 citationsOpen Access

An open-label preliminary trial of sertraline for treatment of major depression after acute myocardial infarction (the SADHAT Trial)

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PSPeter A. ShapiroFLFrançois LespéranceNFNancy Frasure‐Smith

Key Result

Sertraline treatment for major depression after myocardial infarction was well tolerated in >85% of patients, with 12% withdrawing due to adverse events, and improved mood ratings.

Structured PICO

Is sertraline safe and effective for improving mood in patients with major depression after acute myocardial infarction?

P
Population
26 patients with major depressive disorder identified 5 to 30 days after admission for acute myocardial infarction.
I
Intervention
Sertraline
O
Outcome
Cardiovascular and hemostatic function, adverse events, and mood ratingssafety

Sertraline appears safe from a cardiovascular and hemostatic standpoint and improves mood in patients with major depression shortly after an acute myocardial infarction.

Limitations

  • open-label design
  • small sample size (pilot study)

Abstract

BACKGROUND: Depression occurs frequently in patients with acute myocardial infarction and is associated with increased mortality rates. It is not known whether serotonin reuptake inhibitors would be safe and effective for patients with depression after myocardial infarction and whether such treatment would reduce mortality rates. METHODS AND RESULTS: We conducted a multicenter, open-label, pilot study of sertraline treatment in patients with major depressive disorder identified 5 to 30 days after admission for acute myocardial infarction. Outcome measures included cardiovascular and hemostatic function, adverse events, and mood ratings. Twenty-six patients were enrolled in the study. During treatment there were no significant changes in heart rate, blood pressure, cardiac conduction, or left ventricular ejection fraction, and there was a trend toward reduced ventricular ectopic activity. There were no changes in coagulation measures. Bleeding time increased in 12 patients, decreased in 4 patients, and was unchanged in 2 patients. Three (12%) patients withdrew from treatment prematurely because of adverse events. Significant improvements in mood ratings occurred over the course of treatment. CONCLUSIONS: Sertraline treatment was associated with clinical improvement and was well tolerated in >85% of the patients in this open-label treatment trial for patients with major depression after myocardial infarction. These results encourage further controlled trials to establish the effects of treatment for this high-risk population.

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Cite This Study

Shapiro et al. (1999) studied Major depressive disorder after acute myocardial infarction (n=26). Sertraline was evaluated on Cardiovascular and hemostatic function, adverse events, and mood ratings. Sertraline treatment for major depression after myocardial infarction was well tolerated in >85% of patients, with 12% withdrawing due to adverse events, and improved mood ratings.

synapsesocial.com/papers/6aa5c292c616a76b5feed075https://doi.org/10.1016/s0002-8703(99)70369-8
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