Centeno, C., Sanz, A., Cuervo, M.A., Ramos, D., Hernansanz, S., Gonzalez, J., . . . Pascual, A. (2012). Multicentre, double-blind, randomised placebo-controlled clinical trial on the efficacy of methylphenidate on depressive symptoms in advanced cancer patients. BMJ Supportive and Palliative Care, 2, 328–333.

DOI Link

Study Purpose

To study the efficacy of methylphenidate for relief of depressive symptoms in patients with advanced cancer.

Intervention Characteristics/Basic Study Process

Patients who indicated some depressive symptoms from screening were randomized to receive methylphenidate ranging from 10-45 mg daily for 28 days. Doses were adjusted according to individual patient need and toxicity evaluation according to a protocol established for the study. Patient visits and evaluation occurred at days 0, 2, 7, 14, 21, and 28 either in the clinic or the patients’ homes. Patients who completed at least eight days of involvement were included in intent-to-treat analysis using the last measure carried forward.

Sample Characteristics

  • N = 69  
  • MEDIAN AGE = 72 years (range = 40-87)
  • MALES: 58%,FEMALES: 42%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types. Average Karnofsky score range = 50-70
  • OTHER KEY SAMPLE CHARACTERISTICS: About 75% had clinically significant HADS depression scores at baseline, and slightly less than 50% had clinically relevant anxiety scores. All had a life expectance of at least one month.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Multiple settings  
  • LOCATION: Spain

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

  • Double blind, randomized, placebo controlled

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Edmonton Symptom Assessment Scale (ESAS)

Results

After at least one week of treatment, 54% of patients had at least a 2-point decline in depression scores, compared to 31% of those receiving placebo (p = 0.08). There were no significant differences between groups for anxiety. 71% of patients in each group had reported adverse events, and more adverse events per patient were reported by those receiving methylphenidate (p = 0.05).  Most frequent adverse events were insomnia, restlessness, confusion, and faintness.

Conclusions

Methylphenidate administration was not significantly better than placebo for symptoms of depression or anxiety and was associated with more adverse events. The evidence regarding efficacy of methylphenidate is inconclusive.

Limitations

  • Small sample (less than 100)
  • Other limitations/explanation: Study was underpowered

Nursing Implications

This study sample was not large enough to enable firm conclusions from this individual study; however, findings did not show a benefit of methylphenidate and showed more adverse events that may be associated with methylphenidate. These results are not supportive for use of methylphenidate in the management of anxiety and depressive symptoms in patients with advanced cancer.