Depression Clinical Trial
Official title:
Study of Antidepressants in Parkinson's Disease
The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression—a
condition that causes disability and can reduce quality of life. The University of Rochester
Medical Center is conducting a research study of antidepressant medications to find out more
about how to treat depression in PD. Antidepressant medications have not been adequately
studied in persons with PD.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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