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

Donald Sullivan, Solange Mongoue-Tchokote, Motomi (Tomi) Mori, Elizabeth Goy, Linda Ganzini

Research output: Contribution to journalArticle

6 Citations (Scopus)

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.

Original languageEnglish (US)
JournalPsycho-Oncology
DOIs
StateAccepted/In press - 2016

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Methylphenidate
Palliative Care
Placebos
Depression
Neoplasms
Therapeutics
Serotonin Uptake Inhibitors
Terminally Ill
Hospices
Controlled Clinical Trials
Life Expectancy
Sample Size
Anxiety
Mortality

Keywords

  • Advanced stage cancer
  • Depression
  • Hospice
  • Methylphenidate
  • Palliative care
  • Patient-centered outcomes

ASJC Scopus subject areas

  • Experimental and Cognitive Psychology
  • Oncology
  • Psychiatry and Mental health

Cite this

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title = "Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care",
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",
author = "Donald Sullivan and Solange Mongoue-Tchokote and Mori, {Motomi (Tomi)} and Elizabeth Goy and Linda Ganzini",
year = "2016",
doi = "10.1002/pon.4220",
language = "English (US)",
journal = "Psycho-Oncology",
issn = "1057-9249",
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T1 - Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care

AU - Sullivan, Donald

AU - Mongoue-Tchokote, Solange

AU - Mori, Motomi (Tomi)

AU - Goy, Elizabeth

AU - Ganzini, Linda

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Advanced stage cancer

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KW - Hospice

KW - Methylphenidate

KW - Palliative care

KW - Patient-centered outcomes

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