Depression, Parkinson Disease
Conditions
Keywords
Parkinson disease, depression, Parkinson's disease, paroxetine, venlafaxine, antidepressant
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.
Interventions
DRUGparoxetine
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.
DRUGvenlafaxine
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.
OTHERplacebo
an inactive substance
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
Canada, Puerto Rico, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Paroxetine Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | 42 |
| Venlafaxine Extended Release Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | 34 |
| Placebo Paroxetine and venlafaxine will be compared to placebo over 12 weeks. | 39 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 2 | 2 |
| Overall Study | Moved | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 2 |
| Overall Study | Worsening depression | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | Venlafaxine Extended Release | Paroxetine |
|---|---|---|---|---|
| Age Continuous | 63.5 years STANDARD_DEVIATION 10.7 | 62.7 years STANDARD_DEVIATION 11 | 62.5 years STANDARD_DEVIATION 11.4 | 65.2 years STANDARD_DEVIATION 9.8 |
| BDI-II Score | 17.3 Score STANDARD_DEVIATION 8.6 | 17.5 Score STANDARD_DEVIATION 7.4 | 17.1 Score STANDARD_DEVIATION 9.1 | 17.2 Score STANDARD_DEVIATION 9.2 |
| BPRS Score | 34.6 Score STANDARD_DEVIATION 9.6 | 34.4 Score STANDARD_DEVIATION 9.3 | 35.7 Score STANDARD_DEVIATION 8.9 | 33.6 Score STANDARD_DEVIATION 10.7 |
| Education beyond High School Beyond High School | 89 participants | 27 participants | 27 participants | 35 participants |
| Education beyond High School Not beyond High School | 26 participants | 12 participants | 7 participants | 7 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 4 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 35 Participants | 30 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| GDS Score | 15.2 Score STANDARD_DEVIATION 5.6 | 15.0 Score STANDARD_DEVIATION 4.9 | 15.1 Score STANDARD_DEVIATION 5.8 | 15.5 Score STANDARD_DEVIATION 6.2 |
| HAM-D Score | 21.6 Hamilton Depression Score STANDARD_DEVIATION 5.8 | 21.4 Hamilton Depression Score STANDARD_DEVIATION 4.8 | 21.2 Hamilton Depression Score STANDARD_DEVIATION 6 | 22.2 Hamilton Depression Score STANDARD_DEVIATION 6.5 |
| Hoehn and Yahr Stage 1.0-1.5 (Unilateral Parkinson's Disease) | 6 Participants | 3 Participants | 0 Participants | 3 Participants |
| Hoehn and Yahr Stage 2.0-2.5 (Mild Bilateral Parkinson's Disease) | 92 Participants | 31 Participants | 29 Participants | 32 Participants |
| Hoehn and Yahr Stage 3.0-4.0 (Moderate to Severe Bilateral Parkinson's) | 17 Participants | 5 Participants | 5 Participants | 7 Participants |
| MADRS Score | 20.1 Score STANDARD_DEVIATION 6.9 | 19.9 Score STANDARD_DEVIATION 5.9 | 19.4 Score STANDARD_DEVIATION 7.9 | 21.0 Score STANDARD_DEVIATION 6.8 |
| Major Depression No | 42 participants | 17 participants | 12 participants | 13 participants |
| Major Depression Yes | 73 participants | 22 participants | 22 participants | 29 participants |
| Marriage Married | 82 participants | 28 participants | 27 participants | 27 participants |
| Marriage Not married | 33 participants | 11 participants | 7 participants | 15 participants |
| Mini Mental State Examination Score | 28.7 Score STANDARD_DEVIATION 1.6 | 28.5 Score STANDARD_DEVIATION 1.5 | 28.9 Score STANDARD_DEVIATION 1.8 | 28.7 Score STANDARD_DEVIATION 1.4 |
| Motor Fluctuations No | 46 Participants | 15 Participants | 14 Participants | 17 Participants |
| Motor Fluctuations Yes | 69 Participants | 24 Participants | 20 Participants | 25 Participants |
| Past Antidepressant Use No | 105 participants | 34 participants | 32 participants | 39 participants |
| Past Antidepressant Use Yes | 10 participants | 5 participants | 2 participants | 3 participants |
| PDQ-39 Total | 37.9 Score on PDQ-39 Questionnaire STANDARD_DEVIATION 15.6 | 39.6 Score on PDQ-39 Questionnaire STANDARD_DEVIATION 14.8 | 37.2 Score on PDQ-39 Questionnaire STANDARD_DEVIATION 15.6 | 36.8 Score on PDQ-39 Questionnaire STANDARD_DEVIATION 16.3 |
| Schwab/England Activities of Daily Living Score (On) | 81.3 Score STANDARD_DEVIATION 13.1 | 80.8 Score STANDARD_DEVIATION 13.4 | 80.3 Score STANDARD_DEVIATION 14.6 | 82.9 Score STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 42 Participants | 16 Participants | 15 Participants | 11 Participants |
| Sex: Female, Male Male | 73 Participants | 23 Participants | 19 Participants | 31 Participants |
| Short Form-36 Health Survey Scores Mental Component Summary | 39.9 Score STANDARD_DEVIATION 9.4 | 40.0 Score STANDARD_DEVIATION 9.3 | 38.3 Score STANDARD_DEVIATION 10.1 | 41.4 Score STANDARD_DEVIATION 8.8 |
| Short Form-36 Health Survey Scores Physical Component Summary | 36.9 Score STANDARD_DEVIATION 10 | 37.1 Score STANDARD_DEVIATION 10.4 | 36.2 Score STANDARD_DEVIATION 10.3 | 37.5 Score STANDARD_DEVIATION 9.3 |
| Snaith CAS | 7.3 Score STANDARD_DEVIATION 4.2 | 7.5 Score STANDARD_DEVIATION 4.3 | 7.8 Score STANDARD_DEVIATION 4.5 | 6.7 Score STANDARD_DEVIATION 3.9 |
| Treatment for PD - Catechol O-methyltransferase Inhibitor Treatment - No | 86 Participants | 28 Participants | 25 Participants | 33 Participants |
| Treatment for PD - Catechol O-methyltransferase Inhibitor Treatment - Yes | 29 Participants | 11 Participants | 9 Participants | 9 Participants |
| Treatment of PD - Agonist Treatment - No | 73 Participants | 27 Participants | 21 Participants | 25 Participants |
| Treatment of PD - Agonist Treatment - Yes | 42 Participants | 12 Participants | 13 Participants | 17 Participants |
| Treatment of PD - Amantadine Treatment - No | 99 Participants | 33 Participants | 30 Participants | 36 Participants |
| Treatment of PD - Amantadine Treatment - Yes | 16 Participants | 6 Participants | 4 Participants | 6 Participants |
| Treatment of PD - Anticholinergic Treatment - No | 105 Participants | 36 Participants | 30 Participants | 39 Participants |
| Treatment of PD - Anticholinergic Treatment - Yes | 10 Participants | 3 Participants | 4 Participants | 3 Participants |
| Treatment of PD - Levodopa Treatment - No | 18 Participants | 7 Participants | 7 Participants | 4 Participants |
| Treatment of PD - Levodopa Treatment - Yes | 97 Participants | 32 Participants | 27 Participants | 38 Participants |
| UPDRS Score Activities of Daily Living | 26.8 Score STANDARD_DEVIATION 11.1 | 26.4 Score STANDARD_DEVIATION 11.5 | 26.8 Score STANDARD_DEVIATION 12.3 | 27.3 Score STANDARD_DEVIATION 9.6 |
| UPDRS Score Mental | 4.9 Score STANDARD_DEVIATION 2.1 | 4.6 Score STANDARD_DEVIATION 2 | 5.2 Score STANDARD_DEVIATION 1.9 | 4.8 Score STANDARD_DEVIATION 2.4 |
| UPDRS Score Motor | 10.9 Score STANDARD_DEVIATION 6.5 | 10.8 Score STANDARD_DEVIATION 5.5 | 11.4 Score STANDARD_DEVIATION 7.4 | 10.6 Score STANDARD_DEVIATION 6.7 |
| UPDRS Score Total | 42.5 Score STANDARD_DEVIATION 16.6 | 41.7 Score STANDARD_DEVIATION 15.9 | 43.1 Score STANDARD_DEVIATION 19 | 42.7 Score STANDARD_DEVIATION 14.9 |
| Years since PD Diagnosis | 4.9 Years STANDARD_DEVIATION 4.4 | 4.9 Years STANDARD_DEVIATION 3.6 | 4.7 Years STANDARD_DEVIATION 3.7 | 5.2 Years STANDARD_DEVIATION 5.9 |
| Years since PD Onset | 7.0 Years STANDARD_DEVIATION 4.6 | 7.0 Years STANDARD_DEVIATION 3.8 | 7.4 Years STANDARD_DEVIATION 4.2 | 6.7 Years STANDARD_DEVIATION 5.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 42 | 8 / 34 | 9 / 39 |
| serious Total, serious adverse events | 0 / 42 | 0 / 34 | 0 / 39 |
Outcome results
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Hamilton Depression Rating Scale (HAM-D) Scores | -13.0 Change in HAM-D score | Standard Deviation 1.3 |
| Venlafaxine Extended Release | Change in Hamilton Depression Rating Scale (HAM-D) Scores | -11.0 Change in HAM-D score | Standard Deviation 1.4 |
| Placebo | Change in Hamilton Depression Rating Scale (HAM-D) Scores | -6.8 Change in HAM-D score | Standard Deviation 1.3 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Beck Depression Inventory II (BDI-II) | -9.7 Change in BDI-II score | Standard Error 1.1 |
| Venlafaxine Extended Release | Change in Beck Depression Inventory II (BDI-II) | -9.6 Change in BDI-II score | Standard Error 1.2 |
| Placebo | Change in Beck Depression Inventory II (BDI-II) | -5.2 Change in BDI-II score | Standard Error 1.1 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Brief Psychiatric Rating Scale (BPRS) | -9.0 Change in BPRS score | Standard Error 1.3 |
| Venlafaxine Extended Release | Change in Brief Psychiatric Rating Scale (BPRS) | -9.8 Change in BPRS score | Standard Error 1.4 |
| Placebo | Change in Brief Psychiatric Rating Scale (BPRS) | -4.4 Change in BPRS score | Standard Error 1.3 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Geriatric Depression Rating Scale (GDS) | -6.9 Change in GDS score | Standard Error 1 |
| Venlafaxine Extended Release | Change in Geriatric Depression Rating Scale (GDS) | -6.9 Change in GDS score | Standard Error 1.1 |
| Placebo | Change in Geriatric Depression Rating Scale (GDS) | -2.8 Change in GDS score | Standard Error 1 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | -13.6 Change in MADRS score | Standard Error 1.2 |
| Venlafaxine Extended Release | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | -10.9 Change in MADRS score | Standard Error 1.3 |
| Placebo | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | -6.6 Change in MADRS score | Standard Error 1.2 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being | -21.4 Change in PDQ-39 Emotional score | Standard Error 3.3 |
| Venlafaxine Extended Release | Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being | -20.7 Change in PDQ-39 Emotional score | Standard Error 3.5 |
| Placebo | Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being | -10.9 Change in PDQ-39 Emotional score | Standard Error 3.1 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall | -8.0 Change in PDQ-39 score | Standard Error 2.3 |
| Venlafaxine Extended Release | Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall | -8.4 Change in PDQ-39 score | Standard Error 2.4 |
| Placebo | Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall | -5.3 Change in PDQ-39 score | Standard Error 2.1 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Pittsburgh Sleep Quality Index (PSQI) | -2.1 Change in PQSI score | Standard Error 0.4 |
| Venlafaxine Extended Release | Change in Pittsburgh Sleep Quality Index (PSQI) | -2.6 Change in PQSI score | Standard Error 0.5 |
| Placebo | Change in Pittsburgh Sleep Quality Index (PSQI) | -1.1 Change in PQSI score | Standard Error 0.4 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Short Form 36 Health Survey - Mental Component Summary | 11.4 Change in SF-36 mental score | Standard Error 1.7 |
| Venlafaxine Extended Release | Change in Short Form 36 Health Survey - Mental Component Summary | 9.5 Change in SF-36 mental score | Standard Error 1.8 |
| Placebo | Change in Short Form 36 Health Survey - Mental Component Summary | 4.8 Change in SF-36 mental score | Standard Error 1.6 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Short Form 36 Health Survey - Mental Health | 16.7 Change in SF-36 Mental Health score | Standard Error 2.7 |
| Venlafaxine Extended Release | Change in Short Form 36 Health Survey - Mental Health | 17.4 Change in SF-36 Mental Health score | Standard Error 2.8 |
| Placebo | Change in Short Form 36 Health Survey - Mental Health | 9.7 Change in SF-36 Mental Health score | Standard Error 2.5 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Short Form 36 Health Survey - Role-Emotional | 39.5 Change in SF-36 Role score | Standard Error 7.5 |
| Venlafaxine Extended Release | Change in Short Form 36 Health Survey - Role-Emotional | 26.9 Change in SF-36 Role score | Standard Error 8 |
| Placebo | Change in Short Form 36 Health Survey - Role-Emotional | 12.7 Change in SF-36 Role score | Standard Error 6.9 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Short Form 36 Health Survey - Vitality | 13.5 Change in SF-36 vitality score | Standard Error 3.1 |
| Venlafaxine Extended Release | Change in Short Form 36 Health Survey - Vitality | 9.1 Change in SF-36 vitality score | Standard Error 3.3 |
| Placebo | Change in Short Form 36 Health Survey - Vitality | 4.7 Change in SF-36 vitality score | Standard Error 2.9 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Snaith Clinical Anxiety Scale (CAS) | -3.6 Change in CAS score | Standard Error 0.6 |
| Venlafaxine Extended Release | Change in Snaith Clinical Anxiety Scale (CAS) | -3.2 Change in CAS score | Standard Error 0.6 |
| Placebo | Change in Snaith Clinical Anxiety Scale (CAS) | -2.4 Change in CAS score | Standard Error 0.6 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | -8.7 Change in UPDRS score | Standard Error 2.1 |
| Venlafaxine Extended Release | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | -7.0 Change in UPDRS score | Standard Error 2.3 |
| Placebo | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | -4.3 Change in UPDRS score | Standard Error 2 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar | -1.4 Change in UPDRS-Bulbar score | Standard Error 0.3 |
| Venlafaxine Extended Release | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar | -1.4 Change in UPDRS-Bulbar score | Standard Error 0.3 |
| Placebo | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar | -0.5 Change in UPDRS-Bulbar score | Standard Error 0.3 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor | -4.3 Change in UPDRS-motor score | Standard Error 1.5 |
| Venlafaxine Extended Release | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor | -2.0 Change in UPDRS-motor score | Standard Error 1.6 |
| Placebo | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor | -1.0 Change in UPDRS-motor score | Standard Error 1.5 |
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.
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor | 0.4 Change in UPDRS-tremor score | Standard Error 0.5 |
| Venlafaxine Extended Release | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor | 0.5 Change in UPDRS-tremor score | Standard Error 0.5 |
| Placebo | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor | -0.6 Change in UPDRS-tremor score | Standard Error 0.5 |