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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paroxetine | Active Comparator | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. |
|
| venlafaxine extended release | Active Comparator | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. |
|
| placebo | Placebo Comparator | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paroxetine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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Inclusion Criteria:
To be eligible you must be:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Richard, MD | University of Rochester | Principal Investigator |
| William McDonald, MD | Co-Principal Investigator--Emory University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1536634 | Background | Dooneief G, Mirabello E, Bell K, Marder K, Stern Y, Mayeux R. An estimate of the incidence of depression in idiopathic Parkinson's disease. Arch Neurol. 1992 Mar;49(3):305-7. doi: 10.1001/archneur.1992.00530270125028. | |
| 9309555 | Background | Liu CY, Wang SJ, Fuh JL, Lin CH, Yang YY, Liu HC. The correlation of depression with functional activity in Parkinson's disease. J Neurol. 1997 Aug;244(8):493-8. doi: 10.1007/s004150050131. |
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SAD-PD enrolled 115 participants from 20 centers in the US, Canada, and Puerto Rico from June 2005 through March 2009. Participants were recruited from movement disorder clinics. Eligible participants included men and women 30 years and older who were diagnosed with idiopathic PD, without dementia and who met depression criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxetine | Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day. |
| FG001 | Venlafaxine Extended Release | Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| venlafaxine | Drug | 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. |
|
|
| placebo | Other | an inactive substance |
|
| 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. |
| 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. | 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. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| University of Maryland | Baltimore | Maryland | 21250 | United States |
| Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Rochester | Rochester | New York | 14627 | United States |
| Medical University of Ohio | Toledo | Ohio | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Tennessee-Memphis | Memphis | Tennessee | 38163 | United States |
| Baylor College of Medicine, 6550 Fannin, Suite 1801 | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22901 | United States |
| London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road | London | Ontario | N6A 5A5 | Canada |
| Hotel-Dieu Hospital-CHUM | Montreal | Quebec | H2W 1T8 | Canada |
| University of Puerto Rico | San Juan | 00936 | Puerto Rico |
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| Background | Dubovsky S. Geriatric Neuropsychopharmacology. In: Coffey C, Cummings J, eds. Textbook of Geriatric Neuropsychiatry. Washington, DC: American Psychiatric Press, 1994:595-631. |
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| Background | American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC, 1994. |
| Background | Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for Axis I DSM-IV disorders: Biometrics Research Department. New York State Psychiatric Institute 1994. |
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| Background | Fahn S, Elton RL. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent Developments in Parkinson's Disease. Florham Park, NJ: MacMillan Healthcare Information, 1992:153-163. |
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| FG002 | Placebo | Placebo was made to match treatment options. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paroxetine | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. |
| BG001 | Venlafaxine Extended Release | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. |
| BG002 | Placebo | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Education beyond High School | Number | participants |
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| Marriage | Number | participants |
| ||||||||||||||||
| Major Depression | Number | participants |
| ||||||||||||||||
| Past Antidepressant Use | Number | participants |
| ||||||||||||||||
| HAM-D Score | 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. | Mean | Standard Deviation | Hamilton Depression Score |
| ||||||||||||||
| MADRS Score | Montgomery-Asberg Depression Rating Scale. Range 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression. | Mean | Standard Deviation | Score |
| ||||||||||||||
| GDS Score | Geriatric Depression Scale. Range 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression. | Mean | Standard Deviation | Score |
| ||||||||||||||
| BDI-II Score | Beck Depression Inventory II. Range 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression. | Mean | Standard Deviation | Score |
| ||||||||||||||
| Years since PD Onset | Mean | Standard Deviation | Years |
| |||||||||||||||
| Years since PD Diagnosis | Mean | Standard Deviation | Years |
| |||||||||||||||
| Hoehn and Yahr Stage | As the stage rating increases, the severity of the disease increases. Ranges from 1.0 to 5.0. | Number | Participants |
| |||||||||||||||
| UPDRS Score | 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 score = 0. | Mean | Standard Deviation | Score |
| ||||||||||||||
| Schwab/England Activities of Daily Living Score ("On") | Schwab and England Activities of Daily Living Scale (S/E ADL). Range 0-100%. Higher percentage indicates higher level of function and lower impact of disease on life activities. | Mean | Standard Deviation | Score |
| ||||||||||||||
| Motor Fluctuations | Number | Participants |
| ||||||||||||||||
| PDQ-39 Total | Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status. | Mean | Standard Deviation | Score on PDQ-39 Questionnaire |
| ||||||||||||||
| Short Form-36 Health Survey Scores | Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life. | Mean | Standard Deviation | Score |
| ||||||||||||||
| Snaith CAS | Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety. | Mean | Standard Deviation | Score |
| ||||||||||||||
| Mini Mental State Examination Score | Mini Mental State Examination (MMSE). Range 0-30. Higher score indicates better cognitive status. Score less than 9 = severe cognitive impairment, 10-20 moderate impairment, 21-24 mild impairment, 25 and greater considered normal. | Mean | Standard Deviation | Score |
| ||||||||||||||
| BPRS Score | Brief Psychiatric Rating Scale. Maximum score 126, minimum score 0. Higher score indicates greater psychiatric difficulties. | Mean | Standard Deviation | Score |
| ||||||||||||||
| Treatment of PD - Levodopa | Participants taking Levodopa for treatment of Parkinson's Disease. | Number | Participants |
| |||||||||||||||
| Treatment of PD - Agonist | Participants taking Agonist for treatment of Parkinson's Disease. | Number | Participants |
| |||||||||||||||
| Treatment for PD - Catechol O-methyltransferase Inhibitor | Participants taking Catechol O-methyltransferase (COMT) Inhibitor for treatment of Parkinson's Disease. | Number | Participants |
| |||||||||||||||
| Treatment of PD - Amantadine | Participants taking Amantadine for treatment of Parkinson's Disease. | Number | Participants |
| |||||||||||||||
| Treatment of PD - Anticholinergic | Participants taking Anticholinergic for treatment of Parkinson's Disease. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Deviation | Change in HAM-D score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in MADRS score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in BDI-II score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in GDS score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Brief Psychiatric Rating Scale (BPRS) | Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in BPRS score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in UPDRS score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in CAS score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in PQSI score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in UPDRS-motor score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in UPDRS-tremor score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in UPDRS-Bulbar score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in PDQ-39 score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in PDQ-39 Emotional score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in SF-36 mental score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in SF-36 vitality score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in SF-36 Role score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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| Secondary | 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. | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Posted | Mean | Standard Error | Change in SF-36 Mental Health score | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase |
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Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paroxetine | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | 0 | 42 | 10 | 42 | ||
| EG001 | Venlafaxine Extended Release | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | 0 | 34 | 8 | 34 | ||
| EG002 | Placebo | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | 0 | 39 | 9 | 39 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders |
| |||
| Abnormal Dreaming | Psychiatric disorders |
| |||
| Somnolence | Psychiatric disorders |
| |||
| Diaphoresis | Skin and subcutaneous tissue disorders |
| |||
| Pruritis | Skin and subcutaneous tissue disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Sexual Dysfunction | Reproductive system and breast disorders |
| |||
| Fatigue | General disorders |
| |||
| Back Pain | General disorders |
| |||
| Chest Pain | General disorders |
| |||
| Hot Flushes | General disorders |
| |||
| Tremor | Nervous system disorders |
| |||
| Dyskinesia | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Balance Difficulty | Nervous system disorders |
| |||
| Numbness/Parasthesia | Nervous system disorders |
| |||
| Parkinsonism Aggravated | Nervous system disorders |
| |||
| Hypertension | Cardiac disorders |
| |||
| Micturition Difficulty | Renal and urinary disorders |
| |||
| Weight Gain | Metabolism and nutrition disorders |
| |||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders |
| |||
| Agitation | Psychiatric disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Irritability | Psychiatric disorders |
| |||
| Decreased Libido | Psychiatric disorders |
| |||
| Marked Restlessness | Psychiatric disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene H. Richard, MD | University of Rochester Medical Center | 585-341-7500 | irene_richard@urmc.rochester.edu |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Not beyond High School |
|
| Not married |
|
| No |
|
| No |
|
| 2.0-2.5 (Mild Bilateral Parkinson's Disease) |
|
| 3.0-4.0 (Moderate to Severe Bilateral Parkinson's) |
|
| Activities of Daily Living |
|
| Motor |
|
| Total |
|
| No |
|
| Mental Component Summary |
|
| Treatment - No |
|
| Treatment - No |
|
| Treatment - No |
|
| Treatment - No |
|
| Treatment - No |
|
| Participants |
|
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| Participants |
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| Participants |
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| Counts |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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