title: An open-label study of nefazodone treatment of major depression in patients with congestive heart failure.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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 anti-depressant trial. Nefazodone seems sufficiently safe, tolerable, and efficacious to justify a larger, placebo-controlled trial.
authors.affiliation: Department of Psychiatry, Centre Hospitalier, l'Université de Montréal, 3850 St-Urbain, Montreal, QC H2W 1T8. francois.lesperance@umontreal.ca
authors.forename: François
authors.initials: F
authors.lastname: Lespérance
authors.forename: Nancy
authors.initials: N
authors.lastname: Frasure-Smith
authors.forename: Marc-André
authors.initials: MA
authors.lastname: Laliberté
authors.forename: Michel
authors.initials: M
authors.lastname: White
authors.forename: Sylvain
authors.initials: S
authors.lastname: Lafontaine
authors.forename: Angelino
authors.initials: A
authors.lastname: Calderone
authors.forename: Mario
authors.initials: M
authors.lastname: Talajic
authors.forename: Jean-L
authors.initials: JL
authors.lastname: Rouleau
mesh_terms: D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D004562:Electrocardiography; D015716:Electrocardiography, Ambulatory; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis / Q000523:psychology*; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009638:Norepinephrine / Q000097:blood; D010879:Piperazines; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D014230:Triazoles; C051752:nefazodone; D009638:Norepinephrine