Treatment of Depression in Patients With Parkinson's Disease
Treatment of Depression in Parkinson's Disease Trial
Sponsors
Source
Rutgers, The State University of New Jersey
Oversight Info
Has Dmc
Yes
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.
Overall Status
Completed
Start Date
2003-06-01
Completion Date
2009-01-01
Primary Completion Date
2009-01-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Hamilton Depression Scale |
8 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Percent Responders |
8 weeks |
Enrollment
52
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Paroxetine CR 12.5 - 25 mg q hs
Arm Group Label
paroxetine
Other Name
Paxil CR
Intervention Type
Drug
Intervention Name
Description
nortriptyline 25 - 75 mg q hs
Arm Group Label
nortriptyline
Other Name
Pamelor
Eligibility
Criteria
inclusion criteria:
- Parkinson's disease without dementia.
- Depression.
- Males or females.
exclusion criteria:
- Psychosis
- Heart block
Gender
All
Minimum Age
35 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Matthew Menza, M.D. |
Principal Investigator |
Rutgers, The State University of New Jersey |
Location
Facility |
|
Robert Wood Johnson Medical School New Brunswick New Jersey 08901 United States |
Location Countries
Country
United States
Verification Date
2015-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
3
Intervention Browse
Mesh Term
Paroxetine
Nortriptyline
Arm Group
Arm Group Label
nortriptyline
Arm Group Type
Experimental
Description
drug
Arm Group Label
paroxetine
Arm Group Type
Experimental
Description
drug
Arm Group Label
placebo
Arm Group Type
Placebo Comparator
Description
placebo
Results Reference
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.
PMID
19092112
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
June 12, 2003
Study First Submitted Qc
June 12, 2003
Study First Posted
June 13, 2003
Last Update Submitted
October 27, 2015
Last Update Submitted Qc
October 27, 2015
Last Update Posted
November 24, 2015
Results First Submitted
December 5, 2012
Results First Submitted Qc
January 24, 2013
Results First Posted
March 5, 2013
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.