Viewing Study NCT00062738



Ignite Creation Date: 2024-05-05 @ 11:30 AM
Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00062738
Status: COMPLETED
Last Update Posted: 2015-11-24
First Post: 2003-06-12

Brief Title: Treatment of Depression in Parkinsons Disease Trial
Sponsor: Rutgers The State University of New Jersey
Organization: Rutgers The State University of New Jersey

Study Overview

Official Title: Treatment of Depression in Patients With Parkinsons Disease
Status: COMPLETED
Status Verified Date: 2015-10
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: None
Brief Summary: The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine compared to placebo in patients with Parkinsons disease and depression
Detailed Description: Depression is the most common neuropsychiatric disorder found in patients with Parkinsons disease PD It causes immense personal suffering and is associated with increased disability and caregiver burden

Despite the adverse consequences of depression in patients with PD there are virtually no empirical data to guide clinical treatment This study will begin to answer some questions on the treatment of depression by testing a SSRI selective serotonin reuptake inhibitor antidepressant paroxetine a tricyclic antidepressant nortriptyline and placebo in a placebo-controlled trial

A total of 75 patients with PD will be randomized to each of the three arms in a balanced design

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