title: Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care.
abstract: OBJECTIVE
  To determine the effectiveness of methylphenidate for depression treatment in patients with advanced cancer.
  
  
  METHODS
  An 18-day randomized, double-blind, placebo-controlled clinical trial of methylphenidate for treatment of depression in selective serotonin reuptake inhibitor-treated patients with advanced cancer in hospice or receiving palliative care. The primary outcome was depression remission, defined as a ≥50% reduction in score on the Montgomery-Asberg Depression Rating Scale.
  
  
  RESULTS
  Among 47 enrolled participants, 34 were randomized. At study day 18, 85% of the methylphenidate and 60% of the placebo group were in depression remission (P = .22). Mean time to depression remission was 10.3 days [standard error (SE) 1.8] in the methylphenidate and 8.1 (SE 1.3) in the placebo group (P = .48). The mean baseline score for the Hospital Anxiety and Depression Scale (HADS) was 10.4 in each group and decreased by 3.6 (SE 1.1) in the methylphenidate and 2.3 (SE 1.2) in the placebo group (P = .51) by day 18. Once in remission, 1 methylphenidate and 5 placebo participants relapsed to depression (P = .18). There was no difference in mortality between the groups during the trial. Trial results were limited by small sample size attributed to difficulties in recruiting terminally ill patients.
  
  
  CONCLUSIONS
  This trial failed to demonstrate that methylphenidate treatment in selective serotonin reuptake inhibitor-treated patients had a significant effect on depression remission in patients with advanced cancer. This study underscores the difficulties in conducting trials for symptom management in patients with shortened life expectancy.
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University, Portland, OR, USA.|Health Services Research and Development, Veterans Affairs Portland Health Care System, Portland, OR, USA.
authors.forename: Donald R
authors.initials: DR
authors.lastname: Sullivan
authors.affiliation: Knight Cancer Institute, Biostatistics Shared Resource, Oregon Health and Science University, Portland, OR, USA.
authors.forename: Solange
authors.initials: S
authors.lastname: Mongoue-Tchokote
authors.affiliation: School of Public Health, Oregon Health and Science University and Portland State University, Portland, OR, USA.
authors.forename: Motomi
authors.initials: M
authors.lastname: Mori
authors.affiliation: Mental Health and Clinical Neurosciences Division, Veterans Affairs Portland Health Care System, Portland, OR, USA.|Division of Geriatric Psychiatry, Department of Psychiatry, Oregon Health and Science University, Portland, OR, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Goy
authors.affiliation: Health Services Research and Development, Veterans Affairs Portland Health Care System, Portland, OR, USA.|Mental Health and Clinical Neurosciences Division, Veterans Affairs Portland Health Care System, Portland, OR, USA.|Division of Geriatric Psychiatry, Department of Psychiatry, Oregon Health and Science University, Portland, OR, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Ganzini
mesh_terms: D000328:Adult; D000368:Aged; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003863:Depression / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D017051:Hospice Care / Q000379:methods; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000523:psychology*; D010166:Palliative Care / Q000379:methods*; D015990:Placebo Effect; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate; D017367:Selective Serotonin Reuptake Inhibitors
keywords: advanced stage cancer; depression; hospice; methylphenidate; palliative care; patient-centered outcomes