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Completed

NCT Number: NCT00062738

Treatment of Depression in Parkinson's Disease Trial

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease without dementia.
  • Depression.
  • Males or females.

Exclusion criteria

  • Psychosis
  • Heart block

Treatment and study plan

paroxetine

Drug

Paroxetine CR 12.5 - 25 mg q hs

Other names: Paxil CR

Nortriptyline

Drug

nortriptyline 25 - 75 mg q hs

Other names: Pamelor

Placebo

Other

matching placebo

Primary outcomes

  1. Hamilton Depression Scale

    Time frame: 8 weeks

    total score on HDRS (0-54 higher score is worse)

Secondary outcomes

  1. Percent Responders

    Time frame: 8 weeks

    Percent of patients who had a 50% decrease in total HDRS at 8 weeks

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Treatment of Depression in Patients With Parkinson's Disease

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2003
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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