Treatment of Depression in Parkinson's Disease Trial

This study has been completed.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey Identifier:
First received: June 12, 2003
Last updated: October 27, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Parkinson Disease
Drug: paroxetine
Drug: Nortriptyline
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Depression in Patients With Parkinson's Disease

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Hamilton Depression Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    total score on HDRS (0-54 higher score is worse)

Secondary Outcome Measures:
  • Percent Responders [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percent of patients who had a 50% decrease in total HDRS at 8 weeks

Enrollment: 52
Study Start Date: June 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nortriptyline
Drug: Nortriptyline
nortriptyline 25 - 75 mg q hs
Other Name: Pamelor
Experimental: paroxetine
Drug: paroxetine
Paroxetine CR 12.5 - 25 mg q hs
Other Name: Paxil CR
Placebo Comparator: placebo
Other: placebo
matching placebo

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.


Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

inclusion criteria:

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

exclusion criteria:

  • Psychosis
  • Heart block
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00062738

United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Principal Investigator: Matthew Menza, M.D. Rutgers, The State University of New Jersey
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT00062738     History of Changes
Other Study ID Numbers: 4381
Study First Received: June 12, 2003
Results First Received: December 5, 2012
Last Updated: October 27, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
Parkinson's disease
Parkinson disease

Additional relevant MeSH terms:
Depressive Disorder
Parkinson Disease
Basal Ganglia Diseases
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Mood Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on November 25, 2015