NCT00062738

Treatment of Depression in Parkinson's Disease Trial

Treatment of Depression in Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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 Parkinson's disease and depression.

Detailed description

Depression is the most common neuropsychiatric disorder found in patients with Parkinson's 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.

Conditions

• Parkinson Disease
• Depression

Interventions

Type	Name	Description
DRUG	paroxetine	Paroxetine CR 12.5 - 25 mg q hs
DRUG	Nortriptyline	nortriptyline 25 - 75 mg q hs
OTHER	placebo	matching placebo

Timeline

• Start date: 2003-06-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2003-06-13
• Last updated: 2015-11-24
• Results posted: 2013-03-05

Locations

1 site across 1 country: United States