title: Differential effects of paroxetine on fatigue and depression: a randomized, double-blind trial from the University of Rochester Cancer Center Community Clinical Oncology Program.
abstract: OBJECTIVE
  Fatigue and depression typically occur together in cancer patients, suggesting a common etiology, perhaps based on serotonin. This randomized clinical trial tested whether paroxetine, a selective serotonin reuptake inhibitor antidepressant known to modulate brain serotonin, would reduce fatigue in cancer patients and whether any reduction was related to depression.
  
  
  METHODS
  Cancer patients undergoing chemotherapy for the first time were assessed for fatigue. Of 704 patients who reported fatigue at their second chemotherapy cycle, 549 patients were randomly assigned to receive either 20 mg of oral paroxetine hydrochloride daily or placebo for 8 weeks. The assessments of fatigue and depression were performed at cycles 3 and 4 of chemotherapy.
  
  
  RESULTS
  A total of 244 patients treated with paroxetine and 235 patients treated with placebo provided assessable data. No difference was detected in fatigue between patient groups. At the end of the study, there was a difference between groups in the mean level of depression (Center for Epidemiologic Studies Depression scores, 12.0 v 14.8, respectively; P <.01).
  
  
  CONCLUSIONS
  Paroxetine had no influence on fatigue in patients receiving chemotherapy. A possible explanation is that cancer-related fatigue does not involve a reduction in brain 5-HT levels.
authors.affiliation: James P. Wilmot Cancer Center and Department of Biostatistics, University of Rochester Medical Center, NY 14642, USA. gary_morrow@urmc.rochester.edu
authors.forename: Gary R
authors.initials: GR
authors.lastname: Morrow
authors.forename: Jane T
authors.initials: JT
authors.lastname: Hickok
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Roscoe
authors.forename: Richard F
authors.initials: RF
authors.lastname: Raubertas
authors.forename: Paul L R
authors.initials: PL
authors.lastname: Andrews
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Harry E
authors.initials: HE
authors.lastname: Hynes
authors.forename: Tarit K
authors.initials: TK
authors.lastname: Banerjee
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Kirshner
authors.forename: David K
authors.initials: DK
authors.lastname: King
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D003863:Depression / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005221:Fatigue / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D017374:Paroxetine / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors