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SAD-PD: Study of Antidepressants in Parkinson's Disease

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT00086190
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
115
Enrollment
18
Locations
3
Arms
53
Duration (Months)
6.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Antidepressants in Parkinson's Disease
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: paroxetine

Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

Drug: paroxetine
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.
Other Names:
  • Paxil

    		•
    Active Comparator: venlafaxine extended release

    Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

    Drug: venlafaxine
    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.
    Other Names:
  • Effexor XR

    		•
    Placebo Comparator: placebo

    Paroxetine and venlafaxine will be compared to placebo over 12 weeks.

    Other: placebo
    an inactive substance

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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.

    12. 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.

    13. 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.

    14. 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.

    15. 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.

    16. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94143
    2 University of Florida Gainesville Florida United States 32610
    3 University of Miami Miami Florida United States 33136
    4 Emory University School of Medicine Atlanta Georgia United States 30322
    5 University of Kentucky Lexington Kentucky United States 40536
    6 Johns Hopkins University Baltimore Maryland United States 21218
    7 University of Maryland Baltimore Maryland United States 21250
    8 Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue Boston Massachusetts United States 02215
    9 Washington University School of Medicine St. Louis Missouri United States 63110
    10 University of Rochester Rochester New York United States 14627
    11 Medical University of Ohio Toledo Ohio United States
    12 Oregon Health Sciences University Portland Oregon United States 97239
    13 University of Tennessee-Memphis Memphis Tennessee United States 38163
    14 Baylor College of Medicine, 6550 Fannin, Suite 1801 Houston Texas United States 77030
    15 University of Virginia Charlottesville Virginia United States 22901
    16 London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road London Ontario Canada N6A 5A5
    17 Hotel-Dieu Hospital-CHUM Montreal Quebec Canada H2W 1T8
    18 University of Puerto Rico San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • University of Rochester
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Irene Richard, MD, University of Rochester
    • Principal Investigator: William McDonald, MD, Co-Principal Investigator--Emory University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Irene Richard, Irene Richard, MD, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00086190
    Other Study ID Numbers:
    • R01NS046487
    First Posted:
    Jun 29, 2004
    Last Update Posted:
    Jan 4, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Irene Richard, Irene Richard, MD, University of Rochester
    Parkinson disease
    depression
    Parkinson's disease
    paroxetine
    venlafaxine
    antidepressant
    Additional relevant MeSH terms:
    Parkinson Disease
    Depression
    Paroxetine
    Venlafaxine Hydrochloride

    Study Results

    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.
    Pre-assignment Detail
    Arm/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day. Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day. Placebo was made to match treatment options.
    Period Title: Overall Study
    STARTED 42 34 39
    COMPLETED 34 30 33
    NOT COMPLETED 8 4 6

    Baseline Characteristics

    Arm/Group Title Paroxetine Venlafaxine Extended Release Placebo Total
    Arm/Group Description Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Total of all reporting groups
    Overall Participants 42 34 39 115
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.2
    (9.8)
    62.5
    (11.4)
    62.7
    (11.0)
    63.5
    (10.7)
    Sex: Female, Male (Count of Participants)
    Female
    11
    26.2%
    15
    44.1%
    16
    41%
    42
    36.5%
    Male
    31
    73.8%
    19
    55.9%
    23
    59%
    73
    63.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    9.5%
    4
    11.8%
    4
    10.3%
    12
    10.4%
    Not Hispanic or Latino
    38
    90.5%
    30
    88.2%
    35
    89.7%
    103
    89.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Education beyond High School (participants) [Number]
    Beyond High School
    35
    83.3%
    27
    79.4%
    27
    69.2%
    89
    77.4%
    Not beyond High School
    7
    16.7%
    7
    20.6%
    12
    30.8%
    26
    22.6%
    Marriage (participants) [Number]
    Married
    27
    64.3%
    27
    79.4%
    28
    71.8%
    82
    71.3%
    Not married
    15
    35.7%
    7
    20.6%
    11
    28.2%
    33
    28.7%
    Major Depression (participants) [Number]
    Yes
    29
    69%
    22
    64.7%
    22
    56.4%
    73
    63.5%
    No
    13
    31%
    12
    35.3%
    17
    43.6%
    42
    36.5%
    Past Antidepressant Use (participants) [Number]
    Yes
    3
    7.1%
    2
    5.9%
    5
    12.8%
    10
    8.7%
    No
    39
    92.9%
    32
    94.1%
    34
    87.2%
    105
    91.3%
    HAM-D Score (Hamilton Depression Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Hamilton Depression Score]
    22.2
    (6.5)
    21.2
    (6.0)
    21.4
    (4.8)
    21.6
    (5.8)
    MADRS Score (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    21.0
    (6.8)
    19.4
    (7.9)
    19.9
    (5.9)
    20.1
    (6.9)
    GDS Score (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    15.5
    (6.2)
    15.1
    (5.8)
    15.0
    (4.9)
    15.2
    (5.6)
    BDI-II Score (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    17.2
    (9.2)
    17.1
    (9.1)
    17.5
    (7.4)
    17.3
    (8.6)
    Years since PD Onset (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    6.7
    (5.8)
    7.4
    (4.2)
    7.0
    (3.8)
    7.0
    (4.6)
    Years since PD Diagnosis (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    5.2
    (5.9)
    4.7
    (3.7)
    4.9
    (3.6)
    4.9
    (4.4)
    Hoehn and Yahr Stage (Number) [Number]
    1.0-1.5 (Unilateral Parkinson's Disease)
    3
    7.1%
    0
    0%
    3
    7.7%
    6
    5.2%
    2.0-2.5 (Mild Bilateral Parkinson's Disease)
    32
    76.2%
    29
    85.3%
    31
    79.5%
    92
    80%
    3.0-4.0 (Moderate to Severe Bilateral Parkinson's)
    7
    16.7%
    5
    14.7%
    5
    12.8%
    17
    14.8%
    UPDRS Score (Score) [Mean (Standard Deviation) ]
    Mental
    4.8
    (2.4)
    5.2
    (1.9)
    4.6
    (2.0)
    4.9
    (2.1)
    Activities of Daily Living
    27.3
    (9.6)
    26.8
    (12.3)
    26.4
    (11.5)
    26.8
    (11.1)
    Motor
    10.6
    (6.7)
    11.4
    (7.4)
    10.8
    (5.5)
    10.9
    (6.5)
    Total
    42.7
    (14.9)
    43.1
    (19.0)
    41.7
    (15.9)
    42.5
    (16.6)
    Schwab/England Activities of Daily Living Score ("On") (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    82.9
    (11.2)
    80.3
    (14.6)
    80.8
    (13.4)
    81.3
    (13.1)
    Motor Fluctuations (Number) [Number]
    Yes
    25
    59.5%
    20
    58.8%
    24
    61.5%
    69
    60%
    No
    17
    40.5%
    14
    41.2%
    15
    38.5%
    46
    40%
    PDQ-39 Total (Score on PDQ-39 Questionnaire) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score on PDQ-39 Questionnaire]
    36.8
    (16.3)
    37.2
    (15.6)
    39.6
    (14.8)
    37.9
    (15.6)
    Short Form-36 Health Survey Scores (Score) [Mean (Standard Deviation) ]
    Physical Component Summary
    37.5
    (9.3)
    36.2
    (10.3)
    37.1
    (10.4)
    36.9
    (10)
    Mental Component Summary
    41.4
    (8.8)
    38.3
    (10.1)
    40.0
    (9.3)
    39.9
    (9.4)
    Snaith CAS (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    6.7
    (3.9)
    7.8
    (4.5)
    7.5
    (4.3)
    7.3
    (4.2)
    Mini Mental State Examination Score (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    28.7
    (1.4)
    28.9
    (1.8)
    28.5
    (1.5)
    28.7
    (1.6)
    BPRS Score (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    33.6
    (10.7)
    35.7
    (8.9)
    34.4
    (9.3)
    34.6
    (9.6)
    Treatment of PD - Levodopa (Number) [Number]
    Treatment - Yes
    38
    90.5%
    27
    79.4%
    32
    82.1%
    97
    84.3%
    Treatment - No
    4
    9.5%
    7
    20.6%
    7
    17.9%
    18
    15.7%
    Treatment of PD - Agonist (Number) [Number]
    Treatment - Yes
    17
    40.5%
    13
    38.2%
    12
    30.8%
    42
    36.5%
    Treatment - No
    25
    59.5%
    21
    61.8%
    27
    69.2%
    73
    63.5%
    Treatment for PD - Catechol O-methyltransferase Inhibitor (Number) [Number]
    Treatment - Yes
    9
    21.4%
    9
    26.5%
    11
    28.2%
    29
    25.2%
    Treatment - No
    33
    78.6%
    25
    73.5%
    28
    71.8%
    86
    74.8%
    Treatment of PD - Amantadine (Number) [Number]
    Treatment - Yes
    6
    14.3%
    4
    11.8%
    6
    15.4%
    16
    13.9%
    Treatment - No
    36
    85.7%
    30
    88.2%
    33
    84.6%
    99
    86.1%
    Treatment of PD - Anticholinergic (Number) [Number]
    Treatment - Yes
    3
    7.1%
    4
    11.8%
    3
    7.7%
    10
    8.7%
    Treatment - No
    39
    92.9%
    30
    88.2%
    36
    92.3%
    105
    91.3%

    Outcome Measures

    1. Primary Outcome
    Title Change in Hamilton Depression Rating Scale (HAM-D) Scores
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Deviation) [Change in HAM-D score]
    -13.0
    (1.3)
    -11.0
    (1.4)
    -6.8
    (1.3)
    2. Secondary Outcome
    Title Change in Montgomery-Asberg Depression Rating Scale (MADRS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in MADRS score]
    -13.6
    (1.2)
    -10.9
    (1.3)
    -6.6
    (1.2)
    3. Secondary Outcome
    Title Change in Beck Depression Inventory II (BDI-II)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in BDI-II score]
    -9.7
    (1.1)
    -9.6
    (1.2)
    -5.2
    (1.1)
    4. Secondary Outcome
    Title Change in Geriatric Depression Rating Scale (GDS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in GDS score]
    -6.9
    (1.0)
    -6.9
    (1.1)
    -2.8
    (1.0)
    5. Secondary Outcome
    Title Change in Brief Psychiatric Rating Scale (BPRS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in BPRS score]
    -9.0
    (1.3)
    -9.8
    (1.4)
    -4.4
    (1.3)
    6. Secondary Outcome
    Title Change in Unified Parkinson's Disease Rating Scale (UPDRS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in UPDRS score]
    -8.7
    (2.1)
    -7.0
    (2.3)
    -4.3
    (2.0)
    7. Secondary Outcome
    Title Change in Snaith Clinical Anxiety Scale (CAS)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in CAS score]
    -3.6
    (0.6)
    -3.2
    (0.6)
    -2.4
    (0.6)
    8. Secondary Outcome
    Title Change in Pittsburgh Sleep Quality Index (PSQI)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in PQSI score]
    -2.1
    (0.4)
    -2.6
    (0.5)
    -1.1
    (0.4)
    9. Secondary Outcome
    Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in UPDRS-motor score]
    -4.3
    (1.5)
    -2.0
    (1.6)
    -1.0
    (1.5)
    10. Secondary Outcome
    Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in UPDRS-tremor score]
    0.4
    (0.5)
    0.5
    (0.5)
    -0.6
    (0.5)
    11. Secondary Outcome
    Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in UPDRS-Bulbar score]
    -1.4
    (0.3)
    -1.4
    (0.3)
    -0.5
    (0.3)
    12. Secondary Outcome
    Title Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in PDQ-39 score]
    -8.0
    (2.3)
    -8.4
    (2.4)
    -5.3
    (2.1)
    13. Secondary Outcome
    Title Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in PDQ-39 Emotional score]
    -21.4
    (3.3)
    -20.7
    (3.5)
    -10.9
    (3.1)
    14. Secondary Outcome
    Title Change in Short Form 36 Health Survey - Mental Component Summary
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in SF-36 mental score]
    11.4
    (1.7)
    9.5
    (1.8)
    4.8
    (1.6)
    15. Secondary Outcome
    Title Change in Short Form 36 Health Survey - Vitality
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in SF-36 vitality score]
    13.5
    (3.1)
    9.1
    (3.3)
    4.7
    (2.9)
    16. Secondary Outcome
    Title Change in Short Form 36 Health Survey - Role-Emotional
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in SF-36 Role score]
    39.5
    (7.5)
    26.9
    (8.0)
    12.7
    (6.9)
    17. Secondary Outcome
    Title Change in Short Form 36 Health Survey - Mental Health
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Mean change in outcome measure from baseline for participants taking paroxetine. Mean change in outcome measure from baseline for participants taking venlafaxine ER. Mean change in outcome measure from baseline for participants taking placebo.
    Measure Participants 42 34 39
    Mean (Standard Error) [Change in SF-36 Mental Health score]
    16.7
    (2.7)
    17.4
    (2.8)
    9.7
    (2.5)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Paroxetine Venlafaxine Extended Release Placebo
    Arm/Group Description Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
    All Cause Mortality
    Paroxetine Venlafaxine Extended Release Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Paroxetine Venlafaxine Extended Release Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/42 (0%) 0/34 (0%) 0/39 (0%)
    Other (Not Including Serious) Adverse Events
    Paroxetine Venlafaxine Extended Release Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/42 (23.8%) 8/34 (23.5%) 9/39 (23.1%)
    Cardiac disorders
    Hypertension 1/42 (2.4%) 1 4/34 (11.8%) 4 0/39 (0%) 0
    Gastrointestinal disorders
    Constipation 6/42 (14.3%) 6 7/34 (20.6%) 7 5/39 (12.8%) 5
    Nausea 6/42 (14.3%) 6 5/34 (14.7%) 5 5/39 (12.8%) 5
    Diarrhea 3/42 (7.1%) 3 3/34 (8.8%) 3 3/39 (7.7%) 3
    General disorders
    Fatigue 9/42 (21.4%) 9 4/34 (11.8%) 4 5/39 (12.8%) 5
    Back Pain 0/42 (0%) 0 2/34 (5.9%) 2 1/39 (2.6%) 1
    Chest Pain 0/42 (0%) 0 2/34 (5.9%) 2 0/39 (0%) 0
    Hot Flushes 0/42 (0%) 0 0/34 (0%) 0 2/39 (5.1%) 2
    Metabolism and nutrition disorders
    Weight Gain 0/42 (0%) 0 2/34 (5.9%) 2 2/39 (5.1%) 2
    Nervous system disorders
    Tremor 7/42 (16.7%) 7 7/34 (20.6%) 7 3/39 (7.7%) 3
    Dyskinesia 1/42 (2.4%) 1 4/34 (11.8%) 4 3/39 (7.7%) 3
    Dizziness 7/42 (16.7%) 7 3/34 (8.8%) 3 2/39 (5.1%) 2
    Headache 6/42 (14.3%) 6 8/34 (23.5%) 8 6/39 (15.4%) 6
    Balance Difficulty 2/42 (4.8%) 2 3/34 (8.8%) 3 3/39 (7.7%) 3
    Numbness/Parasthesia 3/42 (7.1%) 3 1/34 (2.9%) 1 4/39 (10.3%) 4
    Parkinsonism Aggravated 3/42 (7.1%) 3 5/34 (14.7%) 5 4/39 (10.3%) 4
    Psychiatric disorders
    Insomnia 1/42 (2.4%) 1 7/34 (20.6%) 7 9/39 (23.1%) 9
    Abnormal Dreaming 1/42 (2.4%) 1 1/34 (2.9%) 1 4/39 (10.3%) 4
    Somnolence 8/42 (19%) 8 8/34 (23.5%) 8 5/39 (12.8%) 5
    Agitation 0/42 (0%) 0 2/34 (5.9%) 2 3/39 (7.7%) 3
    Anxiety 1/42 (2.4%) 1 0/34 (0%) 0 5/39 (12.8%) 5
    Irritability 1/42 (2.4%) 1 2/34 (5.9%) 2 6/39 (15.4%) 6
    Decreased Libido 3/42 (7.1%) 3 5/34 (14.7%) 5 2/39 (5.1%) 2
    Marked Restlessness 3/42 (7.1%) 3 1/34 (2.9%) 1 0/39 (0%) 0
    Renal and urinary disorders
    Micturition Difficulty 5/42 (11.9%) 5 1/34 (2.9%) 1 1/39 (2.6%) 1
    Reproductive system and breast disorders
    Sexual Dysfunction 10/42 (23.8%) 10 8/34 (23.5%) 8 4/39 (10.3%) 4
    Respiratory, thoracic and mediastinal disorders
    Upper Respiratory Infection 2/42 (4.8%) 2 1/34 (2.9%) 1 2/39 (5.1%) 2
    Skin and subcutaneous tissue disorders
    Diaphoresis 4/42 (9.5%) 4 4/34 (11.8%) 4 4/39 (10.3%) 4
    Pruritis 3/42 (7.1%) 3 2/34 (5.9%) 2 0/39 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Irene H. Richard, MD
    Organization University of Rochester Medical Center
    Phone 585-341-7500
    Email irene_richard@urmc.rochester.edu
    Responsible Party:
    Irene Richard, Irene Richard, MD, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00086190
    Other Study ID Numbers:
    • R01NS046487
    First Posted:
    Jun 29, 2004
    Last Update Posted:
    Jan 4, 2013
    Last Verified:
    Jan 1, 2013