Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients
- Carlos Centeno1,
- Alvaro Sanz2,
- Miguel Angel Cuervo3,
- Daniel Ramos4,
- Silvia Hernansanz5,
- Jesús Gonzalez6,
- Maria Jose Almaraz7,
- Marcos Lama8,
- Francisco Vara9,
- María Nabal10 and
- Antonio Pascual11
- 1Palliative Care Team, Clinica Universidad de Navarra, Pamplona, Spain
- 2Medical Oncology, Hospital Universitario del Rio Hortega, Valladolid, Spain
- 3Palliative Care Team, Hospital Infanta Cristina, Badajoz, Spain
- 4Palliative Care Team, Hospital Provincial de Zamora, Zamora, Spain
- 5Palliative Care Team, Hospital Clinico Universitario de Valladolid, Valladolid, Spain
- 6Palliative Care Team, Institut Catala Oncologia, Hospitalet, Spain
- 7Palliative Care Unit, Hospital Txagorritxu, Vitoria, Alava, Spain
- 8Palliative Care Unit, Hospital San Juan de Dios, Pamplona, Navarra, Spain
- 9Palliative Medicine Regional Centre, Hospital Universitario de Salamanca, Salamanca, Spain
- 10Palliative Care Unit, Hospital Universitari Arnau de Vilanova, Lleida, Spain
- 11Palliative Care Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain
- Correspondence to Alvaro Sanz, Hospital Universitario del Rio Hortega, Medical Oncology, Valladolid E-47012, Spain;
Contributors CC: He made substantial contributions to conception and design, acquisition of data, and analysis and interpretation of data; he had an essential role in drafting the article; and in final approval of the version to be published. AS, MAC, DR, SH, JG, MJA, ML, FV, MN and AP: They made a substantial contribution to conception and design of the study, acquisition of data and analysis and interpretation of data; they helped in revising the article critically for important intellectual content; and collaborated in the approval of the final version.
Introduction 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.
Material and 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).
Conclusion Compared with the placebo, methylphenidate demonstrated a positive trend in the incidence of response for depressive symptoms in advanced cancer patients.
Funding This study was funded by an unrestricted educational grant from Laboratorios Rubió SA.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
- Accepted 24 April 2012.
- Published Online First 31 May 2012
- Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions