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 cancer patients

We hypothesize that depressed hospice 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 and SSRI.

Condition	Intervention
Depression Hospice Care Cancer Mental Disorder	Drug: Methylphenidate + SSRI/Placebo + SSRI

Further Study Details: 

Primary Outcomes: We''''ll use the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) to measure changes in depression over the 18-day study period.; To measure improvement in depression we will use the depression subscale of the Hospital Anxiety and Depre
Secondary Outcomes: We''''ll determine the degree to which depression improvement is mediated by pain improvement by using the Wisconsin Brief Pain Inventory (WBPI) short version.; The measure of the quality of life of patients at the end of life (QUAL-E) was chosen to help
Expected Total Enrollment:  104

Objective: To determine the effectiveness and safety of methylphenidate for depression treatment in cancer patients in hospice.

Research Design: We will conduct an 18-day randomized, double-blind, placebo-controlled clinical trial of methylphenidate for depression in eligible veteran and non-veteran cancer patients in inpatient hospice and non-VA community hospice who are concurrently receiving a selective serotonin reuptake inhibitor (SSRI). We will determine whether improvement in depression is mediated by decreased pain and document the safety and tolerability of methylphenidate in these patients. We will explore whether improvement in depression results in improved quality of life for these patients, and decreases caregiver depression and burden.

Methodology: Veterans and nonveterans who enter inpatient hospice or nonVA community home hospice, have advanced cancer, and answer yes to the question “are you sad or depressed” will be invited to participate. They will complete measures of depression [Structured Clinical Interview for Diagnosis (SCID), Montgomery-Asberg Depression Rating Scale (MADRS) as primary outcome, Hospital Anxiety and Depression Scale as secondary outcome], quality of life, pain, and cognition at baseline. MADRS score must be greater 19 and SCID positive for depression at study entry. Subjects will be randomized to either methylphenidate plus SSRI or placebo plus SSRI. Participants will be evaluated with the same measures as baseline on days 3, 6, 12 and 18 of the study. In an open label portion of the study, methylphenidate-treated patients will be followed up to 2 months. Cox proportional hazard analysis will be used to analyze the primary outcome. An estimated 104 subjects will be entered over four years. Caregivers will complete measures of depression and caregiver burden at days 0 and 18.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Either enrolled in the Legacy-VNA home hospice, Legacy inpatient hospice (Hopewell House), VA inpatient hospice, or a veteran living within 30 miles of the Portland VAMC who is referred to 1 of 4 local home hospices.
2. Life-limiting disease is any type of solid or blood cancer.
3. Eighteen years of age or older.
4. Life expectancy of 6 months or less as reflected by hospice admission.
5. Diagnosis of major depression disorder as determined by the Structured Clinical Interview for Diagnosis (SCID)
6. Significant depressive cognitive symptomatology as determined by a MADRAS greater than 19.
7. Currently taking an SSRI but still depressed enough to meet eligibility criteria or not taking SSRI but depressed enough to start on SSRI
8. Willing and able to give informed consent to participate in this study as demonstrated by the MacArthur Competence Assessment Tool for research.
9. Speaks/understands English.

Exclusion Criteria:

1 Dementia or Delirium as determined by the Short Portable Mental Status Questionnaire (SPMSQ) score of less than 7.

2. Diagnosis of delirium as determined by the Confusional Assessment Method (CAM).

3. Any of the following Brief Psychiatric Rating Scale (BPRS) items rated greater than 4 – mania, elated mood, suspiciousness, hallucinations, excitement, distractibility or motor hyperactivity.

4. Severe insomnia 5. Severe anxiety 6. Significant suicidal ideation 7. History of current mental disorder in which depressive symptoms occur, but for which psychostimulants are contraindicated (schizophrenia and bipolar disorder will be based on history; active psychotic symptoms on selected BPRS items.

8. History of stimulant abuse or other active, severe substance abuse. 9. Contraindications to methylphenidate or an SSRI including significant ventricular arrhythmias; uncontrolled, severe hypertension; moderate-severe angina; seizure disorder; severe COPD, use of medications such as Levodopa, monoamine oxidase inhibitors, and lithium; or history of SSRI-induced hyponatremia.

10. Treatment for depression with a non-SSRI antidepressant including Bupropion and Venlafaxine during protocol.

11. Known serum creatinine greater than 3.0, or severe liver disease as reflected by jaundice or hepatic encephalopathy.

12. Receiving hospice care in a skilled nursing facility.

Please refer to this study by ClinicalTrials.gov identifier  NCT00129467

Oregon
      Portland, Portland,  Oregon,  97239,  United States; Recruiting

Study chairs or principal investigators

Linda K. Ganzini, MD MPH,  Principal Investigator,  Portland   

Study ID Numbers:  IIR 03-194; 01153; 10-0603; CPC-04115-LX
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129467
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23