Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
115 participants
INTERVENTIONAL
2005-06-30
2009-11-30
Brief Summary
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Detailed Description
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The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.
This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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paroxetine
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
paroxetine
Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
venlafaxine extended release
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
venlafaxine
Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
placebo
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
placebo
an inactive substance
Interventions
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paroxetine
Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
venlafaxine
Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
placebo
an inactive substance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 30 years old or older
* diagnosed with Parkinson's disease
* experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
30 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Rochester
OTHER
Responsible Party
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Irene Richard
Irene Richard, MD
Principal Investigators
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Irene Richard, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
William McDonald, MD
Role: PRINCIPAL_INVESTIGATOR
Co-Principal Investigator--Emory University School of Medicine
Locations
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University of California San Francisco
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Rochester
Rochester, New York, United States
Medical University of Ohio
Toledo, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Tennessee-Memphis
Memphis, Tennessee, United States
Baylor College of Medicine, 6550 Fannin, Suite 1801
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
London, Ontario, Canada
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, Canada
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Other Identifiers
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