N/A
N=32
Methylphenidate for Depressed Cancer Patients Receiving Palliative Care
Depression · Palliative Care · Cancer · Mental Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00129467 ↗Enrolled (actual)
32
Serious AEs
34.4%
Results posted
Feb 2014
Primary outcome: Primary: Days to Remission of Depression — 10.3; 8.1 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methylphenidate (Drug); Placebo (Drug); Selective Serotonin Uptake Inhibitor (SSRI) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days to Remission of Depression |
10.3; 8.1 | — |
Summary
The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.
Eligibility Criteria
Inclusion Criteria
Inclusion:
- Either enrolled in the OHSU radiology/oncology clinic or VA palliative care, and living within 120 miles of the Portland VAMC.
- Life-limiting disease is any type of solid or blood cancer.
- Eighteen years of age or older.
- Life expectancy of 1 year or less as reflected by hospice admission or palliative care status. Although exact life expectancy can not be predicted, actively dying patients with estimated life expectancy of 3.0, or severe liver disease as reflected by jaundice or hepatic encephalopathy.
- Unable to swallow pills, however if patient has gastrostomy tube or feeding tube in place the study medicines may be administered by this route. Pills may be poured into food.
- Receiving hospice care in a skilled nursing facility.
Data sourced from ClinicalTrials.gov (NCT00129467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.