Methylphenidate for Depressed Cancer Patients Receiving Palliative Care

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00129467
First received: August 9, 2005
Last updated: April 18, 2013
Last verified: April 2011
  Purpose

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.


Condition Intervention
Depression
Palliative Care
Cancer
Mental Disorder
Drug: Methylphenidate + SSRI
Drug: SSRI + placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methylphenidate for Depressed Cancer Patients in Hospice

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The MADRS will measure change in depression over the 18-day study. A subscale of the HADS will measure improvement in depression. To assess the safety & tolerability of methylphenidate a review of possible side effects will be administered at each visit. [ Time Frame: 18 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The degree to which depression improvement is mediated by pain (WBP Inventory). The measure of quality of life at the end of life will help examine whether methylphenidate treatment results in improvements in the various domains of quality of life. [ Time Frame: 18 days ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: February 2005
Study Completion Date: December 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Subjects receiving SSRI + methylphenidate
Drug: Methylphenidate + SSRI
Subjects assigned to SSRI + methylphenidate will take methylphenidate 5 mg twice daily (8 AM and noon) for 3 days, then 2 capsules (10mg active ingredient) twice per day for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of study medication (methylphenidate 5mg at 8:00am or noon, or placebo), they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%. During the 18-day blinded treatment period the total daily dose will not exceed 20 mg. Similarly, subjects assigned to SSRI + placebo will receive 1 capsule of placebo twice daily (8 AM and noon) for 3 days and follow identical dose titration guidelines.
Placebo Comparator: Arm 2
Subjects receiving SSRI + placebo
Drug: SSRI + placebo
Subjects assigned to SSRI + placebo will receive 1 capsule of placebo twice daily (8 AM and noon) for 3 days and follow identical dose titration guidelines.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 10 days are unlikely to be enrolled.
  • Diagnosis of major depression disorder as determined by the Structured Clinical Interview for Diagnosis (SCID).
  • Significant depressive cognitive symptomatology as determined by a MADRS greater than 19.
  • Currently taking an SSRI but still depressed enough to meet eligibility criteria or not taking SSRI but depressed enough to start on SSRI.
  • Willing and able to give informed consent to participate in this study as demonstrated by the MacArthur Competence Assessment Tool for clinical research.
  • Speaks/understands English.
  • For patients at home who cannot self-administer medications, has a caregiver who can assist with administering medication.

Exclusion Criteria:

Exclusion:

  • Dementia or Delirium as determined by the Short Portable Mental Status Questionnaire (SPMSQ) score of less than 7.
  • Diagnosis of delirium as determined by the Confusional Assessment Method (CAM).
  • Any of the following Brief Psychiatric Rating Scale (BPRS) items rated 4 -, elated mood, suspiciousness, hallucinations, excitement, distractibility or motor hyperactivity.
  • Severe insomnia.
  • Severe anxiety.
  • Significant suicidal ideation.
  • 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).
  • History of stimulant abuse or other active, severe substance abuse.
  • Contraindications to methylphenidate or an SSRI including significant cardiacarrhythmias; uncontrolled, severe hypertension; moderate-severe angina; seizure disorder; severe COPD; use of medications such as Levodopa, monoamine oxidase inhibitors, and lithium; diagnosis of narrow-angle glaucoma; or history of SSRI-induced hyponatremia,.
  • Physical symptoms including increased blood pressure (DBP greater than 115, SBP greater than 180), pulse greater than 120, irregular pulse, or chest pain consistant with angina.
  • Treatment for depression with a non-SSRI antidepressant including Bupropion and Venlafaxine during protocol.
  • Known serum creatinine > 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129467

Locations
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239-2964
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Linda K. Ganzini, MD MPH Portland VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00129467     History of Changes
Other Study ID Numbers: IIR 03-194, 01153, 10-0603, CPC-04115-LX
Study First Received: August 9, 2005
Last Updated: April 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Depression
Hospice Care
Antidepressive Agents
Methylphenidate
Central Nervous System Stimulant
Pain
Caregiver Burden
Cancer

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Depression
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
Mood Disorders
Central Nervous System Stimulants
Methylphenidate
Antidepressive Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013