Treatment of Depression in Parkinson's Disease Trial

Phase 2

Completed

• Conditions: Parkinson Disease; Depression
• Interventions: Other: placebo; Drug: paroxetine; Drug: Nortriptyline

• Registration Number: NCT00062738
• Lead Sponsor: Rutgers, The State University of New Jersey

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 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-12
• Study First Submitted QC: 2003-06-12
• Study First Posted: 2003-06-13
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2012-12-05
• Results First Submitted QC: 2013-01-24
• Results First Posted: 2013-03-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
paroxetine	paroxetine	drug
nortriptyline	Nortriptyline	drug

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale	8 weeks	total score on HDRS (0-54 higher score is worse)

Secondary Outcome Measures

Name	Time	Method
Percent Responders	8 weeks	Percent of patients who had a 50% decrease in total HDRS at 8 weeks

Trial Locations

Locations (1)

Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States