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Study of Antidepressants in Parkinson's Disease (SAD-PD)

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ClinicalTrials.gov Identifier: NCT00086190
Recruitment Status : Completed
First Posted : June 29, 2004
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Irene Richard, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson Disease
Depression
Interventions Drug: paroxetine
Drug: venlafaxine
Other: placebo
Enrollment 115
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 Details  
Arm/Group Title Paroxetine Venlafaxine Extended Release Placebo
Hide 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
Reason Not Completed
Adverse Event             6             2             2
Withdrawal by Subject             0             2             2
Protocol Violation             1             0             0
Moved             1             0             0
Worsening depression             0             0             2
Arm/Group Title Paroxetine Venlafaxine Extended Release Placebo Total
Hide 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 Number of Baseline Participants 42 34 39 115
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 34 participants 39 participants 115 participants
65.2  (9.8) 62.5  (11.4) 62.7  (11.0) 63.5  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Female
11
  26.2%
15
  44.1%
16
  41.0%
42
  36.5%
Male
31
  73.8%
19
  55.9%
23
  59.0%
73
  63.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 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
   0.0%
0
   0.0%
Education beyond High School  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Beyond High School 35 27 27 89
Not beyond High School 7 7 12 26
Marriage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Married 27 27 28 82
Not married 15 7 11 33
Major Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Yes 29 22 22 73
No 13 12 17 42
Past Antidepressant Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Yes 3 2 5 10
No 39 32 34 105
HAM-D Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Hamilton Depression Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
22.2  (6.5) 21.2  (6.0) 21.4  (4.8) 21.6  (5.8)
[1]
Measure Description: 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.
MADRS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
21.0  (6.8) 19.4  (7.9) 19.9  (5.9) 20.1  (6.9)
[1]
Measure Description: 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.
GDS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
15.5  (6.2) 15.1  (5.8) 15.0  (4.9) 15.2  (5.6)
[1]
Measure Description: Geriatric Depression Scale. Range 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
BDI-II Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
17.2  (9.2) 17.1  (9.1) 17.5  (7.4) 17.3  (8.6)
[1]
Measure Description: 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.
Years since PD Onset  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 34 participants 39 participants 115 participants
6.7  (5.8) 7.4  (4.2) 7.0  (3.8) 7.0  (4.6)
Years since PD Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 34 participants 39 participants 115 participants
5.2  (5.9) 4.7  (3.7) 4.9  (3.6) 4.9  (4.4)
Hoehn and Yahr Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
1.0-1.5 (Unilateral Parkinson's Disease) 3 0 3 6
2.0-2.5 (Mild Bilateral Parkinson's Disease) 32 29 31 92
3.0-4.0 (Moderate to Severe Bilateral Parkinson's) 7 5 5 17
[1]
Measure Description: As the stage rating increases, the severity of the disease increases. Ranges from 1.0 to 5.0.
UPDRS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
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)
[1]
Measure 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 score = 0.
Schwab/England Activities of Daily Living Score ("On")   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
82.9  (11.2) 80.3  (14.6) 80.8  (13.4) 81.3  (13.1)
[1]
Measure Description: 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.
Motor Fluctuations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Yes 25 20 24 69
No 17 14 15 46
PDQ-39 Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on PDQ-39 Questionnaire
Number Analyzed 42 participants 34 participants 39 participants 115 participants
36.8  (16.3) 37.2  (15.6) 39.6  (14.8) 37.9  (15.6)
[1]
Measure Description: Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Short Form-36 Health Survey Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
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)
[1]
Measure Description: Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Snaith CAS   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
6.7  (3.9) 7.8  (4.5) 7.5  (4.3) 7.3  (4.2)
[1]
Measure Description: Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Mini Mental State Examination Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
28.7  (1.4) 28.9  (1.8) 28.5  (1.5) 28.7  (1.6)
[1]
Measure Description: 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.
BPRS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 42 participants 34 participants 39 participants 115 participants
33.6  (10.7) 35.7  (8.9) 34.4  (9.3) 34.6  (9.6)
[1]
Measure Description: Brief Psychiatric Rating Scale. Maximum score 126, minimum score 0. Higher score indicates greater psychiatric difficulties.
Treatment of PD - Levodopa   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Treatment - Yes 38 27 32 97
Treatment - No 4 7 7 18
[1]
Measure Description: Participants taking Levodopa for treatment of Parkinson's Disease.
Treatment of PD - Agonist   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Treatment - Yes 17 13 12 42
Treatment - No 25 21 27 73
[1]
Measure Description: Participants taking Agonist for treatment of Parkinson's Disease.
Treatment for PD - Catechol O-methyltransferase Inhibitor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Treatment - Yes 9 9 11 29
Treatment - No 33 25 28 86
[1]
Measure Description: Participants taking Catechol O-methyltransferase (COMT) Inhibitor for treatment of Parkinson's Disease.
Treatment of PD - Amantadine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Treatment - Yes 6 4 6 16
Treatment - No 36 30 33 99
[1]
Measure Description: Participants taking Amantadine for treatment of Parkinson's Disease.
Treatment of PD - Anticholinergic   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 39 participants 115 participants
Treatment - Yes 3 4 3 10
Treatment - No 39 30 36 105
[1]
Measure Description: Participants taking Anticholinergic for treatment of Parkinson's Disease.
1.Primary Outcome
Title Change in Hamilton Depression Rating Scale (HAM-D) Scores
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: 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
Hide 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
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Hide 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
Hide 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.
Overall Number of Participants Analyzed 42 34 39
Mean (Standard Error)
Unit of Measure: Change in SF-36 Mental Health score
16.7  (2.7) 17.4  (2.8) 9.7  (2.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paroxetine Venlafaxine Extended Release Placebo
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paroxetine Venlafaxine Extended Release Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/34 (0.00%)      0/39 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paroxetine Venlafaxine Extended Release Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/42 (23.81%)      8/34 (23.53%)      9/39 (23.08%)    
Cardiac disorders       
Hypertension  1/42 (2.38%)  1 4/34 (11.76%)  4 0/39 (0.00%)  0
Gastrointestinal disorders       
Constipation  6/42 (14.29%)  6 7/34 (20.59%)  7 5/39 (12.82%)  5
Nausea  6/42 (14.29%)  6 5/34 (14.71%)  5 5/39 (12.82%)  5
Diarrhea  3/42 (7.14%)  3 3/34 (8.82%)  3 3/39 (7.69%)  3
General disorders       
Fatigue  9/42 (21.43%)  9 4/34 (11.76%)  4 5/39 (12.82%)  5
Back Pain  0/42 (0.00%)  0 2/34 (5.88%)  2 1/39 (2.56%)  1
Chest Pain  0/42 (0.00%)  0 2/34 (5.88%)  2 0/39 (0.00%)  0
Hot Flushes  0/42 (0.00%)  0 0/34 (0.00%)  0 2/39 (5.13%)  2
Metabolism and nutrition disorders       
Weight Gain  0/42 (0.00%)  0 2/34 (5.88%)  2 2/39 (5.13%)  2
Nervous system disorders       
Tremor  7/42 (16.67%)  7 7/34 (20.59%)  7 3/39 (7.69%)  3
Dyskinesia  1/42 (2.38%)  1 4/34 (11.76%)  4 3/39 (7.69%)  3
Dizziness  7/42 (16.67%)  7 3/34 (8.82%)  3 2/39 (5.13%)  2
Headache  6/42 (14.29%)  6 8/34 (23.53%)  8 6/39 (15.38%)  6
Balance Difficulty  2/42 (4.76%)  2 3/34 (8.82%)  3 3/39 (7.69%)  3
Numbness/Parasthesia  3/42 (7.14%)  3 1/34 (2.94%)  1 4/39 (10.26%)  4
Parkinsonism Aggravated  3/42 (7.14%)  3 5/34 (14.71%)  5 4/39 (10.26%)  4
Psychiatric disorders       
Insomnia  1/42 (2.38%)  1 7/34 (20.59%)  7 9/39 (23.08%)  9
Abnormal Dreaming  1/42 (2.38%)  1 1/34 (2.94%)  1 4/39 (10.26%)  4
Somnolence  8/42 (19.05%)  8 8/34 (23.53%)  8 5/39 (12.82%)  5
Agitation  0/42 (0.00%)  0 2/34 (5.88%)  2 3/39 (7.69%)  3
Anxiety  1/42 (2.38%)  1 0/34 (0.00%)  0 5/39 (12.82%)  5
Irritability  1/42 (2.38%)  1 2/34 (5.88%)  2 6/39 (15.38%)  6
Decreased Libido  3/42 (7.14%)  3 5/34 (14.71%)  5 2/39 (5.13%)  2
Marked Restlessness  3/42 (7.14%)  3 1/34 (2.94%)  1 0/39 (0.00%)  0
Renal and urinary disorders       
Micturition Difficulty  5/42 (11.90%)  5 1/34 (2.94%)  1 1/39 (2.56%)  1
Reproductive system and breast disorders       
Sexual Dysfunction  10/42 (23.81%)  10 8/34 (23.53%)  8 4/39 (10.26%)  4
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Infection  2/42 (4.76%)  2 1/34 (2.94%)  1 2/39 (5.13%)  2
Skin and subcutaneous tissue disorders       
Diaphoresis  4/42 (9.52%)  4 4/34 (11.76%)  4 4/39 (10.26%)  4
Pruritis  3/42 (7.14%)  3 2/34 (5.88%)  2 0/39 (0.00%)  0
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
Publications:
Dubovsky S. Geriatric Neuropsychopharmacology. In: Coffey C, Cummings J, eds. Textbook of Geriatric Neuropsychiatry. Washington, DC: American Psychiatric Press, 1994:595-631.
Applebaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press, 2001.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC, 1994.
Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for Axis I DSM-IV disorders: Biometrics Research Department. New York State Psychiatric Institute 1994.
Conners C, Barkley R. Rating scales and checklists for psychopharmacologic trials. Psychopharm Bull 1985;21:80-854.
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.
Little RJA, Rubin DB. Statistical Analysis with Missing Data, Second Edition. Hoboken: John Wiley and Sons, 2002.
Responsible Party: Irene Richard, University of Rochester
ClinicalTrials.gov Identifier: NCT00086190     History of Changes
Other Study ID Numbers: R01NS046487 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2004
First Posted: June 29, 2004
Results First Submitted: January 11, 2012
Results First Posted: January 4, 2013
Last Update Posted: January 4, 2013