title: Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients.
abstract: BACKGROUND
  Methylphenidate is a psychostimulant that has been used to relieve depressive symptoms in advanced cancer patients. No studies compare its efficacy against placebo in this group of patients.
  
  
  OBJECTIVE
  To explore the efficacy of methylphenidate compared with placebo in the relief of depressive symptoms in advanced cancer patients.
  
  
  METHODS
  A multicentre, double-blind, randomised placebo-controlled clinical trial was undertaken comparing the efficacy of methylphenidate and placebo in depressive symptoms. Advanced stage cancer patients were eligible if they scored at least two points on the Two Question Screening Survey for depression. A reduction of at least two points on the Edmonton Symptom Assessment Scale for depression (0-10) was considered as a response.
  
  
  RESULTS
  Sixty-nine patients were included (methylphenidate: n=31, placebo: n=38); median daily dose of methylphenidate was 25 mg. Fifty-eight patients (84%) who completed the first week of treatment were considered suitable for evaluation. In the intention to treat analysis, there were 14/31 (45%) responses with methylphenidate and 10/38 (26%) responses with placebo (difference: 19%; 95% CI: 4% to 39%; p=0.10). With the Hospital Anxiety and Depression Scale, 11/19 (58%) patients with methylphenidate and 10/24 (42%) with placebo improved from a score compatible with depression in the first 7 days (difference 16%; 95% CI 13% to 42%; p=0.29). The proportion of patients indicating adverse effects was similar for both cohorts (p=0.99).
  
  
  CONCLUSIONS
  Compared with the placebo, methylphenidate demonstrated a positive trend in the incidence of response for depressive symptoms in advanced cancer patients.
authors.affiliation: Palliative Care Team, Clinica Universidad de Navarra, Pamplona, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Centeno
authors.forename: Alvaro
authors.initials: A
authors.lastname: Sanz
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Cuervo
authors.forename: Daniel
authors.initials: D
authors.lastname: Ramos
authors.forename: Silvia
authors.initials: S
authors.lastname: Hernansanz
authors.forename: Jesús
authors.initials: J
authors.lastname: Gonzalez
authors.forename: Maria Jose
authors.initials: MJ
authors.lastname: Almaraz
authors.forename: Marcos
authors.initials: M
authors.lastname: Lama
authors.forename: Francisco
authors.initials: F
authors.lastname: Vara
authors.forename: María
authors.initials: M
authors.lastname: Nabal
authors.forename: Antonio
authors.initials: A
authors.lastname: Pascual
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003863:Depression / Q000150:complications* / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000523:psychology*; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D010919:Placebos; D008774:Methylphenidate