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Steven P. Roose, MD; Fouzia Laghrissi-Thode, MD; John S. Kennedy, MD; J. Craig Nelson, MD; J. Thomas Bigger, Jr, MD; Bruce G. Pollock, MD, PhD; Andrew Gaffney, MD; Meena Narayan, MD; Mitchell S. Finkel, MD; James McCafferty; Ivan Gergel, MD

JAMA. 1998;279:287-291.

Context.— Depression and ischemic heart disease often are comorbid conditions and, in patients who have had a myocardial infarction, the presence of depression is associated with increased mortality. Patients with heart disease need a safe and effective treatment for depression.

Objective.— To compare the efficacy, cardiovascular effects, and safety of a specific serotonin reuptake inhibitor, paroxetine, with a tricyclic antidepressant, nortriptyline hydrochloride, in depressed patients with ischemic heart disease.

Design.— Two-week placebo lead-in followed by a double-blind randomized 6-week medication trial.

Setting.— Research clinics in 4 university centers.

Patients.— Eighty-one outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for major depressive disorder and with documented ischemic heart disease.

Interventions.— Treatment with either paroxetine, 20 to 30 mg/d, or nortriptyline targeted to a therapeutic plasma level, 190 to 570 nmol/L (50-150 ng/mL), for 6 weeks.

Main Outcome Measures.— For effectiveness of treatment, a decline in the score of the Hamilton Rating Scale for Depression by 50% and final score of 8 or less; for cardiovascular safety, heart rate and rhythm, supine and standing systolic and diastolic blood pressures, electrocardiogram conduction intervals, indexes of heart rate variability, and rate of adverse events.

Results.— By intent-to-treat analysis, 25 (61%) of 41 patients improved during treatment with paroxetine and 22 (55%) of 40 improved with nortriptyline. Neither drug significantly affected blood pressure or conduction intervals. Paroxetine had no sustained effects on heart rate or rhythm or indexes of heart rate variability, whereas patients treated with nortriptyline had a sustained 11% increase in heart rate from a mean of 75 to 83 beats per minute (P<.001) and a reduction in heart rate variability, as measured by the SD of all normal R-R intervals over a 24-hour period, from 112 to 96 (P<.01). Adverse cardiac events occurred in 1 (2%) of 41 patients treated with paroxetine and 7 (18%) of 40 patients treated with nortriptyline (P<.03).

Conclusions.— Paroxetine and nortriptyline are effective treatments for depressed patients with ischemic heart disease. Nortriptyline treatment was associated with a significantly higher rate of serious adverse cardiac events compared with paroxetine.

From the Departments of Psychiatry (Dr Roose), Medicine (Dr Bigger), and Pharmacology (Dr Bigger), College of Physicians and Surgeons, Columbia University, New York, NY; Department of Psychiatry (Drs Laghrissi-Thode and Pollock), University of Pittsburgh School of Medicine, Pittsburgh, Pa; Departments of Psychiatry (Dr Kennedy), Medicine (Dr Gaffney), and Clinical Cardiology (Dr Gaffney), Vanderbilt University School of Medicine, Nashville, Tenn; Department of Psychiatry (Drs Nelson and Narayan), Yale University School of Medicine, New Haven, Conn; Department of Medicine, Section of Cardiology, West Virginia University School of Medicine, Morgantown (Dr Finkel); and Department of Clinical Research and Development, SmithKline Beecham Pharmaceuticals, Philadelphia, Pa (Mr McCafferty and Dr Gergel). Drs Roose and Kennedy have received research support and honoraria from Eli Lilly and Company and from SmithKline Beecham Pharmaceuticals. Drs Nelson and Pollock have received research support and honoraria from SmithKline Beecham.

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