Objectives:To evaluate the feasibility of screening and recruiting patients with major depression and congestive heart failure (CHF) in a tertiary care cardiology hospital and to obtain preliminary efficacy, tolerability, and safety data for nefazodone treatment of a major depressive episode in CHF patients. Method:We conducted a 12-week, open-label trial of nefazodone given in dosages up to 600 mg daily. We assessed patients at baseline, 1, 2, 4, 8, and 12 weeks. Measures used were the 17-item Hamilton Depression Rating Scale (HDRS), the Clinical Global Impression Scale, the Beck Depression Inventory, Spielberger's State-Trait Anxiety Inventory, and the Minnesota Living with Heart Failure Questionnaire. We also obtained pre-and poststudy ECGs, 24-hour Holter monitor recordings, and plasma levels of norepinephrine.Results: After screening 443 CHF patients, 28 patients with major depression met study eligibility criteria. The 23 patients who completed 4 or more weeks of medication showed significant improvement on all depression scales and in quality of life. Of 19 subjects who completed the full 12-week trial, 74% experienced a decline of 50% or more on HDRS scores. The completers also showed a significant reduction in heart rate, an increase in QT intervals (but not in the QTc), and a marginally significant decrease in plasma norepinephrine. There were no changes in heart rate variability. Conclusions:It is feasible to screen and recruit CHF patients with major depression for an antidepressant trial. Nefazodone seems sufficiently safe, tolerable, and efficacious to justify a larger, placebo-controlled trial. (Can J Psychiatry 2003;48:695-701) Information on funding and support and author affiliations apears at the end of the article. Clinical Implications· It is difficult, but feasible, to screen and recruit congestive heart failure patients with major depression. · The preliminary tolerability, safety, and efficacy data justify a larger, randomized, placebocontrolled trial in this population. · Nefazodone may reduce sympathetic activation. Limitations· The study had an open-label design. · The sample size was small. · The sample was taken from a tertiary care cardiology hospital.

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