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Treatment of Depression in Parkinson's Disease Trial

Primary Purpose

Parkinson Disease, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paroxetine
Nortriptyline
placebo
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Parkinson disease, depression, antidepressants, nortriptyline, paroxetine

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

inclusion criteria: Parkinson's disease without dementia. Depression. Males or females. exclusion criteria: Psychosis Heart block

Sites / Locations

  • Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

nortriptyline

paroxetine

placebo

Arm Description

drug

drug

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2003
Last Updated
October 27, 2015
Sponsor
Rutgers, The State University of New Jersey
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00062738
Brief Title
Treatment of Depression in Parkinson's Disease Trial
Official Title
Treatment of Depression in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Depression
Keywords
Parkinson's disease, Parkinson disease, depression, antidepressants, nortriptyline, paroxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nortriptyline
Arm Type
Experimental
Arm Description
drug
Arm Title
paroxetine
Arm Type
Experimental
Arm Description
drug
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
paroxetine
Other Intervention Name(s)
Paxil CR
Intervention Description
Paroxetine CR 12.5 - 25 mg q hs
Intervention Type
Drug
Intervention Name(s)
Nortriptyline
Other Intervention Name(s)
Pamelor
Intervention Description
nortriptyline 25 - 75 mg q hs
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Hamilton Depression Scale
Description
total score on HDRS (0-54 higher score is worse)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percent Responders
Description
Percent of patients who had a 50% decrease in total HDRS at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria: Parkinson's disease without dementia. Depression. Males or females. exclusion criteria: Psychosis Heart block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Menza, M.D.
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19092112
Citation
Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17.
Results Reference
result
PubMed Identifier
20808132
Citation
Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Friedman J. Depression in Parkinson's disease: symptom improvement and residual symptoms after acute pharmacologic management. Am J Geriatr Psychiatry. 2011 Mar;19(3):222-9. doi: 10.1097/JGP.0b013e3181e448f7.
Results Reference
derived
PubMed Identifier
20463113
Citation
Dobkin RD, Menza M, Bienfait KL, Gara M, Marin H, Mark MH, Dicke A, Troster A. The impact of antidepressant treatment on cognitive functioning in depressed patients with Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2010 Spring;22(2):188-95. doi: 10.1176/jnp.2010.22.2.188.
Results Reference
derived

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Treatment of Depression in Parkinson's Disease Trial

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