Treatment of Depression in Parkinson's Disease Trial

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00062738
First received: June 12, 2003
Last updated: February 28, 2014
Last verified: February 2014
  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
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
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

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

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

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 ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: June 12, 2003
Results First Received: December 5, 2012
Last Updated: February 28, 2014
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
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
Nortriptyline
Paroxetine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 20, 2014