title: A pilot study to evaluate symptom-oriented selection of antidepressants in patients with cancer.
abstract: BACKGROUND
  Major depressive disorder (MDD) is a common and debilitating illness in patients with cancer. However, the optimal treatment of depression in these patients remains uncertain, with limited evidence to support the use of pharmacologic therapy. We conducted a pilot study to evaluate the feasibility of an antidepressant clinical trial in the oncology population and the process of symptom-oriented selection of antidepressants (citalopram or mirtazapine) in patients with cancer and MDD.
  
  
  METHODS
  This was a single center, two-arm, nonrandomized, open-label, nine-week pilot study of mirtazapine or citalopram in cancer patients with MDD. The primary endpoint was the feasibility to recruit and to retain patients. Secondary outcomes included changes in Patient Health Questionnaire-9 (PHQ-9) (depression), Functional Assessment of Cancer Therapy-General (FACT-G) (quality of life), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) (fatigue), and Pittsburgh Sleep Quality Index (PSQI) (sleep). We conducted descriptive statistics and responder analyses.
  
  
  RESULTS
  Of 21 patients, 18 (86%) successfully completed the study. An average of 2.8 subjects were enrolled per month. Mean scores on the PHQ-9 improved overall by 6.4 points (95% confidence interval [CI] 3.6-9.2). Additionally, mean FACT-G, FACIT-Fatigue, and PSQI scores improved in both study arms.
  
  
  CONCLUSIONS
  Conducting antidepressant clinical trials is challenging in the oncology population. We approached but did not meet our feasibility goals. Depression and quality of life (QOL) scores improved with both mirtazapine and citalopram, but evidence-based pharmacologic treatments for depression in cancer patients are needed.
authors.affiliation: 1 Department of Medical Oncology, Bon Secours Cancer Institute , Richmond, Virginia.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Raddin
authors.forename: Eliza M
authors.initials: EM
authors.lastname: Park
authors.forename: Robert M
authors.initials: RM
authors.lastname: Hamer
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Nelson
authors.forename: Deborah K
authors.initials: DK
authors.lastname: Mayer
authors.forename: Donald L
authors.initials: DL
authors.lastname: Rosenstein
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Bernard
mesh_terms: D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D015283:Citalopram / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008803:Mianserin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D000078785:Mirtazapine; D009369:Neoplasms / Q000523:psychology*; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018687:Antidepressive Agents, Second-Generation; D000929:Antidepressive Agents, Tricyclic; D015283:Citalopram; D008803:Mianserin; D000078785:Mirtazapine