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.

Condition	Treatment or Intervention	Phase
Parkinson Disease Depression	Drug: paroxetine  Drug: venlafaxine	Phase III

Further Study Details: 

Expected Total Enrollment:  228

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 controlled release (Paxil CR) and venlafaxine extended release (Effexor XR). Paroxetine CR and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine CR 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.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: To be eligible you must be:

• 30 years old or older
• diagnosed with Parkinson’s disease
• experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping

Nancy Pearson, RN, MS      585-273-2982 

California
      University of Southern California, Los Angeles,  California,  90001,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
Maryland
      University of Maryland, Baltimore,  Maryland,  21250,  United States
      Johns Hopkins University, Baltimore,  Maryland,  21218,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
New York
      University of Rochester, Rochester,  New York,  14627,  United States
      Albany Medical Center, Albany,  New York,  12208,  United States
      North Shore University, Long Island,  New York,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27708,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97239,  United States
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
Rhode Island
      Memorial Hospital of Rhode Island--Brown University, Pawtucket,  Rhode Island,  02860,  United States
Virginia
      University of Virginia, Charlottesville,  Virginia,  22901,  United States
Canada, Quebec
      McGill Centre for Studies in Aging, Verdun,  Quebec,  Canada
Puerto Rico
      University of Puerto Rico, San Juan,  00936,  Puerto Rico

Study chairs or principal investigators

Irene Richard, MD,  Principal Investigator,  University of Rochester   
William McDonald, MD,  Co-Principal Investigator--Emory University School of Medicine   

Study ID Numbers:  R01NS046487
Record last reviewed:  October 2004
Last Updated:  October 22, 2004
Record first received:  June 28, 2004
ClinicalTrials.gov Identifier:  NCT00086190
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08