Trial Outcomes & Findings for Methylphenidate for Depressed Cancer Patients Receiving Palliative Care (NCT NCT00129467)
NCT ID: NCT00129467
Last Updated: 2015-04-24
Results Overview
Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
18 Days
Results posted on
2015-04-24
Participant Flow
Subjects were enrolled from February 2005 through August 2009. Potential subjects were recruited from: a VA Nursing Skilled Care Unit, VA outpatient oncology and palliative care clinics, a community hospice and oncology and radiation clinics at a university hospital affiliated with a VA medical center.
Subjects completed screening scales on depression, cognition, and psychiatric symptoms and their medical records were reviewed to confirm eligibility. 47 subjects were enrolled, 12 did not meet criteria, 1 person declined screening after consenting, 2 subjects were randomized but did not receive the intervention (1 withdrew and 1 became ineligible)
Participant milestones
| Measure |
Methylphenidate + SSRI
During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
|
Placebo + SSRI
During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
|
|---|---|---|
|
Received Intervention
STARTED
|
15
|
17
|
|
Received Intervention
COMPLETED
|
9
|
13
|
|
Received Intervention
NOT COMPLETED
|
6
|
4
|
|
Open Label for SSRI+Methylphenidate Arm
STARTED
|
4
|
0
|
|
Open Label for SSRI+Methylphenidate Arm
COMPLETED
|
2
|
0
|
|
Open Label for SSRI+Methylphenidate Arm
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Methylphenidate + SSRI
During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
|
Placebo + SSRI
During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
|
|---|---|---|
|
Received Intervention
Death
|
1
|
1
|
|
Received Intervention
Cardiac SAE (hypertension)
|
1
|
1
|
|
Received Intervention
Delirium
|
2
|
0
|
|
Received Intervention
Withdrawal by Subject
|
1
|
0
|
|
Received Intervention
Nausea
|
1
|
0
|
|
Received Intervention
Intolerance to citalopram
|
0
|
1
|
|
Received Intervention
Dizzyness, fatigue
|
0
|
1
|
|
Open Label for SSRI+Methylphenidate Arm
Death
|
1
|
0
|
|
Open Label for SSRI+Methylphenidate Arm
Delirium
|
1
|
0
|
Baseline Characteristics
Methylphenidate for Depressed Cancer Patients Receiving Palliative Care
Baseline characteristics by cohort
| Measure |
Methylphenidate + SSRI
n=15 Participants
During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
|
Placebo + SSRI
n=17 Participants
During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 15 • n=5 Participants
|
66 years
STANDARD_DEVIATION 13 • n=7 Participants
|
64 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Marital Status
Married
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Marital Status
Single
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Partnership
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
|
13.5 Years
STANDARD_DEVIATION 2 • n=5 Participants
|
11.9 Years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
12.7 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Type of Cancer
Gastrointestinal
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Type of Cancer
Pulmonary
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Type of Cancer
Urogenital
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of Cancer
Breast
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of Cancer
Prostate
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of Cancer
Neurological
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Type of Cancer
Dermatological
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Type of Cancer
Head and Neck
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Type of Cancer
Hematological
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 DaysPopulation: The number of participants analyzed is the number of who received the intervention
Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.
Outcome measures
| Measure |
Methylphenidate + SSRI
n=15 Participants
During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
|
Placebo + SSRI
n=17 Participants
During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
|
|---|---|---|
|
Days to Remission of Depression
|
10.3 Days
Standard Error 1.77
|
8.1 Days
Standard Error 1.31
|
Adverse Events
Methylphenidate + SSRI
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo + SSRI
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylphenidate + SSRI
n=15 participants at risk
During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
|
Placebo + SSRI
n=17 participants at risk
During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
40.0%
6/15 • Number of events 6 • 30 days after participants' last day in study
|
17.6%
3/17 • Number of events 3 • 30 days after participants' last day in study
|
|
Cardiac disorders
New cardiac symptom
|
6.7%
1/15 • Number of events 1 • 30 days after participants' last day in study
|
5.9%
1/17 • Number of events 1 • 30 days after participants' last day in study
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Linda Ganzini
Portland Veterans Affairs Medical Center
Phone: (503) 220-8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place