Randomized, Double-Blind, Placebo-Controlled Study of Methylphenidate for Treatment of Depression in Cancer Patients Enrolled in Hospice or Receiving Palliative Care (S723)

Abstract

•Understand the efficacy of methylphenidate for depression treatment in cancer patients receiving hospice or palliative care.•Understand the safety of methylphenidate for depression treatment in cancer patients receiving hospice or palliative care. Major depressive disorder can be diagnosed in up to 49% of patients with advanced cancer. This disorder causes suffering and is associated with suicidality and increased pain. Traditional antidepressants in cancer patients in hospice or receiving palliative care are complicated by shortened life expectancy, as they take several weeks to reach effectiveness. Methylphenidate has been reported in case series as a rapidly effective treatment for depression. To determine the safety and efficacy of methylphenidate for depression treatment in cancer patients receiving hospice or palliative care. An 18-day randomized, double-blind clinical trial of methylphenidate for depression in eligible patients with advanced cancer who were enrolled in hospice or receiving palliative care. Patients were randomized to receive methylphenidate plus a selective serotonin reuptake inhibitor (SSRI) versus placebo plus SSRI. In total, 46 patients were enrolled, however 14 were excluded before randomization or did not receive study drug. At day 18, 84.6 % of the methylphenidate and 60% of the placebo group were in depression remission (p = NS), which was measured as a >50% reduction in score on the clinician-rated Montgomery-Asberg Depression Rating Scale. Mean time to remission of depression was 10.3 days (SE 1.77) in the methylphenidate and 8.1 days (SE 1.31) in the placebo group (p = 0.38, log rank test). HADS scores from baseline to day 18 were not statistically different between the two groups. Methylphenidate was well tolerated with few side effects, and mortality was not different between the two groups. This clinical trial was unable to support the primary hypothesis that methylphenidate decreases depression in cancer patients in hospice or receiving palliative care. Low enrollment and higher than anticipated remission rates impacted comparisons. Methylphenidate was well tolerated with few side effects in this patient population.