Study of Antidepressants in Parkinson's Disease
- Conditions
- Parkinson DiseaseDepression
- Interventions
- Registration Number
- NCT00086190
- Lead Sponsor
- University of Rochester
- Brief Summary
The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.
- Detailed Description
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.
The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.
This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
To be eligible you must be:
- 30 years old or older
- diagnosed with Parkinson's disease
- experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Paroxetine and venlafaxine will be compared to placebo over 12 weeks. paroxetine paroxetine Paroxetine and venlafaxine will be compared to placebo over 12 weeks. venlafaxine extended release venlafaxine Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
- Primary Outcome Measures
Name Time Method Change in Hamilton Depression Rating Scale (HAM-D) Scores from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.
- Secondary Outcome Measures
Name Time Method Change in Montgomery-Asberg Depression Rating Scale (MADRS) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.
Change in Beck Depression Inventory II (BDI-II) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
Change in Geriatric Depression Rating Scale (GDS) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
Change in Brief Psychiatric Rating Scale (BPRS) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.
Change in Snaith Clinical Anxiety Scale (CAS) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Change in Pittsburgh Sleep Quality Index (PSQI) from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
Change in Short Form 36 Health Survey - Mental Component Summary from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Change in Short Form 36 Health Survey - Vitality from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Change in Short Form 36 Health Survey - Role-Emotional from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Change in Short Form 36 Health Survey - Mental Health from the beginning (0 weeks) to end (12 weeks) of the double-blind phase Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Trial Locations
- Locations (18)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Hotel-Dieu Hospital-CHUM
🇨🇦Montreal, Quebec, Canada
University of Rochester
🇺🇸Rochester, New York, United States
Baylor College of Medicine, 6550 Fannin, Suite 1801
🇺🇸Houston, Texas, United States
London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
🇨🇦London, Ontario, Canada
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
University of Tennessee-Memphis
🇺🇸Memphis, Tennessee, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
🇺🇸Boston, Massachusetts, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Medical University of Ohio
🇺🇸Toledo, Ohio, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States