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Treatment of Depression in Parkinson's Disease Trial

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ClinicalTrials.gov Identifier: NCT00062738
Recruitment Status : Completed
First Posted : June 13, 2003
Results First Posted : March 5, 2013
Last Update Posted : November 24, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Depression Drug: paroxetine Drug: Nortriptyline Other: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Study Start Date : June 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hamilton Depression Scale [ Time Frame: 8 weeks ]
    total score on HDRS (0-54 higher score is worse)

Secondary Outcome Measures :
  1. Percent Responders [ Time Frame: 8 weeks ]
    Percent of patients who had a 50% decrease in total HDRS at 8 weeks

Information from the National Library of Medicine

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

inclusion criteria:

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

exclusion criteria:

  • Psychosis
  • Heart block

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

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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
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Principal Investigator: Matthew Menza, M.D. Rutgers, The State University of New Jersey
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00062738    
Other Study ID Numbers: 4381
First Posted: June 13, 2003    Key Record Dates
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
Additional relevant MeSH terms:
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Parkinson Disease
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
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