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Trial record 3 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

Methylphenidate for Depressed Cancer Patients Receiving Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00129467
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : February 12, 2014
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Palliative Care
Cancer
Mental Disorder
Interventions Drug: Methylphenidate
Drug: Placebo
Drug: Selective Serotonin Uptake Inhibitor (SSRI)
Enrollment 47
Recruitment Details 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.
Pre-assignment Details 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)
Arm/Group Title Methylphenidate + SSRI Placebo + SSRI
Hide Arm/Group Description 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. 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.
Period Title: Received Intervention
Started 15 17
Completed 9 13
Not Completed 6 4
Reason Not Completed
Death             1             1
Cardiac SAE (hypertension)             1             1
Delirium             2             0
Withdrawal by Subject             1             0
Nausea             1             0
Intolerance to citalopram             0             1
Dizzyness, fatigue             0             1
Period Title: Open Label for SSRI+Methylphenidate Arm
Started 4 [1] 0
Completed 2 0
Not Completed 2 0
Reason Not Completed
Death             1             0
Delirium             1             0
[1]
Eligible if in methylphenidate arm & had 50% reduction in Montgomery-Asberg Depression Rating score
Arm/Group Title Methylphenidate + SSRI Placebo + SSRI Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
The number of baseline participants is the number of subjects who received the intervention
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  60.0%
7
  41.2%
16
  50.0%
>=65 years
6
  40.0%
10
  58.8%
16
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
62  (15) 66  (13) 64  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
7
  46.7%
0
   0.0%
7
  21.9%
Male
8
  53.3%
17
 100.0%
25
  78.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
15
 100.0%
17
 100.0%
32
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.7%
0
   0.0%
1
   3.1%
White
14
  93.3%
17
 100.0%
31
  96.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 17 participants 32 participants
15 17 32
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Married 4 7 11
Single 2 1 3
Divorced 7 5 12
Widowed 2 3 5
Partnership 0 1 1
Education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
13.5  (2) 11.9  (3.3) 12.7  (2.8)
Type of Cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Gastrointestinal 5 7 12
Pulmonary 2 5 7
Urogenital 0 2 2
Breast 2 0 2
Prostate 1 1 2
Neurological 0 0 0
Dermatological 2 1 3
Head and Neck 3 1 4
Hematological 0 0 0
1.Primary Outcome
Title Days to Remission of Depression
Hide Description Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.
Time Frame 18 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is the number of who received the intervention
Arm/Group Title Methylphenidate + SSRI Placebo + SSRI
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 17
Mean (Standard Error)
Unit of Measure: Days
10.3  (1.77) 8.1  (1.31)
Time Frame 30 days after participants' last day in study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate + SSRI Placebo + SSRI
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Methylphenidate + SSRI Placebo + SSRI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate + SSRI Placebo + SSRI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/15 (46.67%)      4/17 (23.53%)    
Cardiac disorders     
New cardiac symptom   1/15 (6.67%)  1 1/17 (5.88%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death   6/15 (40.00%)  6 3/17 (17.65%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Methylphenidate + SSRI Placebo + SSRI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/17 (0.00%)    
Frequency threshold for reporting nonserious adverse events was not determined at the start of the study, but a % was required to be entered in order to complete the adverse event module
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Linda Ganzini
Organization: Portland Veterans Affairs Medical Center
Phone: (503) 220-8262 ext 56492
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00129467     History of Changes
Other Study ID Numbers: IIR 03-194
01153 ( Other Identifier: Portland VAMC IRB )
10-0603 ( Other Identifier: Portland VAMC R&D )
CPC-04115-LX ( Other Identifier: OHSU Knight Cancer Institute )
First Submitted: August 9, 2005
First Posted: August 11, 2005
Results First Submitted: October 16, 2013
Results First Posted: February 12, 2014
Last Update Posted: April 24, 2015