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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
115
Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
an inactive substance
University of California San Francisco
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Change in Hamilton Depression Rating Scale (HAM-D) Scores
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Beck Depression Inventory II (BDI-II)
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Geriatric Depression Rating Scale (GDS)
Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Brief Psychiatric Rating Scale (BPRS)
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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University of Miami
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Maryland
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Rochester
Rochester, New York, United States
...and 8 more locations
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Snaith Clinical Anxiety Scale (CAS)
Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Component Summary
Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Vitality
Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Role-Emotional
Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Health
Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase