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Treatment of Depression in Parkinson's Disease Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00062738
First Posted: June 13, 2003
Last Update Posted: November 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  Purpose
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 Depression Drug: paroxetine Drug: Nortriptyline Other: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    total score on HDRS (0-54 higher score is worse)


Secondary Outcome Measures:
  • Percent Responders [ Time Frame: 8 weeks ]
    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
Drug: Nortriptyline
nortriptyline 25 - 75 mg q hs
Other Name: Pamelor
Experimental: paroxetine
drug
Drug: paroxetine
Paroxetine CR 12.5 - 25 mg q hs
Other Name: Paxil CR
Placebo Comparator: placebo
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

inclusion criteria:

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

exclusion criteria:

  • Psychosis
  • Heart block
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062738


Locations
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
GlaxoSmithKline
Investigators
Principal Investigator: Matthew Menza, M.D. Rutgers, The State University of New Jersey
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00062738     History of Changes
Other Study ID Numbers: 4381
First Submitted: June 12, 2003
First Posted: June 13, 2003
Results First Submitted: December 5, 2012
Results First Posted: March 5, 2013
Last Update Posted: November 24, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Paroxetine
Nortriptyline
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors