Viewing Study NCT00086190



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00086190
Status: COMPLETED
Last Update Posted: 2013-01-04
First Post: 2004-06-28

Brief Title: Study of Antidepressants in Parkinsons Disease
Sponsor: University of Rochester
Organization: University of Rochester

Study Overview

Official Title: Study of Antidepressants in Parkinsons Disease
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SAD-PD
Brief Summary: The purpose of this study is to find out if two antidepressant medications paroxetine and venlafaxine can help control depression in Parkinsons disease and if these medications affect the motor symptoms of Parkinsons disease such as tremor stiffness slowness and balance
Detailed Description: Nearly 50 percent of individuals with Parkinsons 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None