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Randomized Controlled Trial
. 2017 Nov;26(11):1763-1769.
doi: 10.1002/pon.4220. Epub 2016 Aug 12.

Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care

Donald R Sullivan  1   2 , Solange Mongoue-Tchokote  3 , Motomi Mori  4 , Elizabeth Goy  5   6 , Linda Ganzini  2   5   6
Affiliations
Randomized Controlled Trial

Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care

Donald R Sullivan et al. Psychooncology. 2017 Nov.

Abstract

Objective: To determine the effectiveness of methylphenidate for depression treatment in patients with advanced cancer.

Design: 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.

Keywords: advanced stage cancer; depression; hospice; methylphenidate; palliative care; patient-centered outcomes.

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Figures

Figure 1
Figure 1
Figure 2
Figure 2. Depression Remission in the Methylphenidate and Placebo Groups
Percentage of participants in the methylphenidate and placebo groups with ≥50% reduction in MADRS score from baseline (remission) versus <50% reduction in MADRS score from baseline (depressed) during the 18-day trial (p=0.22).
See this image and copyright information in PMC

References

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