title: Conducting an antidepressant clinical trial in oncology: challenges and strategies to address them.
abstract: OBJECTIVE
  The aim of this report is to discuss the design of an antidepressant clinical trial and discuss the challenges and potential solutions to these challenges to successful recruitment of oncology patients for psychopharmacology trials.
  
  
  METHODS
  We utilize meeting minutes and investigator discussions to identify the modifiable and nonmodifiable variables that affected successful subject recruitment for this study.
  
  
  RESULTS
  No subjects were enrolled in our placebo-controlled antidepressant trial. After study modification to remove the placebo arm, we enrolled 21 subjects with depression and cancer. We identified the following recruitment difficulties during the study: diagnostic ambiguity in patients with depression and cancer, lowered subject retention in a medically ill population, patient reluctance to enroll in placebo-controlled studies and lack of a standardized referral processes for antidepressant studies in oncology at our institution.
  
  
  CONCLUSIONS
  Our experience provides guidance on specific factors that future clinicians and researchers can consider when implementing psychopharmacologic trials in the medically ill.
authors.affiliation: Department of Psychiatry, University of North Carolina, Chapel Hill, NC. Electronic address: leeza_park@med.unc.edu.
authors.forename: Eliza M
authors.initials: EM
authors.lastname: Park
authors.affiliation: Bon Secours Cancer Institute, Richmond, VA.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Raddin
authors.affiliation: Department of Psychiatry, University of North Carolina, Chapel Hill, NC.
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Nelson
authors.affiliation: Department of Psychiatry, University of North Carolina, Chapel Hill, NC; Department of Biostatistics, University of North Carolina, Chapel Hill, NC.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Hamer
authors.affiliation: School of Nursing, University of North Carolina, Chapel Hill, NC.
authors.forename: Deborah K
authors.initials: DK
authors.lastname: Mayer
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Bernard
authors.affiliation: Department of Psychiatry, University of North Carolina, Chapel Hill, NC; Department of Medicine, Division of Hematology/Oncology, University of North Carolina, Chapel Hill, NC.
authors.forename: Donald L
authors.initials: DL
authors.lastname: Rosenstein
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D018849:Controlled Clinical Trials as Topic / Q000592:standards; D003863:Depression / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D009369:Neoplasms / Q000523:psychology*; D018579:Patient Selection; D010919:Placebos
chemical_list: D000928:Antidepressive Agents; D010919:Placebos
keywords: Antidepressant trial; Cancer; Depression; Oncology