Trial Outcomes & Findings for Study of Antidepressants in Parkinson's Disease (NCT NCT00086190)
NCT ID: NCT00086190
Last Updated: 2013-01-04
Results Overview
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.
COMPLETED
PHASE3
115 participants
from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
2013-01-04
Participant Flow
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.
Participant milestones
| Measure |
Paroxetine
Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
|
Venlafaxine Extended Release
Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
|
Placebo
Placebo was made to match treatment options.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
34
|
39
|
|
Overall Study
COMPLETED
|
34
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
6
|
Reasons for withdrawal
| Measure |
Paroxetine
Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
|
Venlafaxine Extended Release
Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
|
Placebo
Placebo was made to match treatment options.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Moved
|
1
|
0
|
0
|
|
Overall Study
Worsening depression
|
0
|
0
|
2
|
Baseline Characteristics
Study of Antidepressants in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Paroxetine
n=42 Participants
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
|
Venlafaxine Extended Release
n=34 Participants
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
|
Placebo
n=39 Participants
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
65.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Education beyond High School
Beyond High School
|
35 participants
n=5 Participants
|
27 participants
n=7 Participants
|
27 participants
n=5 Participants
|
89 participants
n=4 Participants
|
|
Education beyond High School
Not beyond High School
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Marriage
Married
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
28 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Marriage
Not married
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Major Depression
Yes
|
29 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Major Depression
No
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
17 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Past Antidepressant Use
Yes
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Past Antidepressant Use
No
|
39 participants
n=5 Participants
|
32 participants
n=7 Participants
|
34 participants
n=5 Participants
|
105 participants
n=4 Participants
|
|
HAM-D Score
|
22.2 Hamilton Depression Score
STANDARD_DEVIATION 6.5 • n=5 Participants
|
21.2 Hamilton Depression Score
STANDARD_DEVIATION 6.0 • n=7 Participants
|
21.4 Hamilton Depression Score
STANDARD_DEVIATION 4.8 • n=5 Participants
|
21.6 Hamilton Depression Score
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
MADRS Score
|
21.0 Score
STANDARD_DEVIATION 6.8 • n=5 Participants
|
19.4 Score
STANDARD_DEVIATION 7.9 • n=7 Participants
|
19.9 Score
STANDARD_DEVIATION 5.9 • n=5 Participants
|
20.1 Score
STANDARD_DEVIATION 6.9 • n=4 Participants
|
|
GDS Score
|
15.5 Score
STANDARD_DEVIATION 6.2 • n=5 Participants
|
15.1 Score
STANDARD_DEVIATION 5.8 • n=7 Participants
|
15.0 Score
STANDARD_DEVIATION 4.9 • n=5 Participants
|
15.2 Score
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
BDI-II Score
|
17.2 Score
STANDARD_DEVIATION 9.2 • n=5 Participants
|
17.1 Score
STANDARD_DEVIATION 9.1 • n=7 Participants
|
17.5 Score
STANDARD_DEVIATION 7.4 • n=5 Participants
|
17.3 Score
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Years since PD Onset
|
6.7 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
7.4 Years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
7.0 Years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
7.0 Years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
|
Years since PD Diagnosis
|
5.2 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
4.7 Years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
4.9 Years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
4.9 Years
STANDARD_DEVIATION 4.4 • n=4 Participants
|
|
Hoehn and Yahr Stage
1.0-1.5 (Unilateral Parkinson's Disease)
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Hoehn and Yahr Stage
2.0-2.5 (Mild Bilateral Parkinson's Disease)
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Hoehn and Yahr Stage
3.0-4.0 (Moderate to Severe Bilateral Parkinson's)
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
UPDRS Score
Mental
|
4.8 Score
STANDARD_DEVIATION 2.4 • n=5 Participants
|
5.2 Score
STANDARD_DEVIATION 1.9 • n=7 Participants
|
4.6 Score
STANDARD_DEVIATION 2.0 • n=5 Participants
|
4.9 Score
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
UPDRS Score
Activities of Daily Living
|
27.3 Score
STANDARD_DEVIATION 9.6 • n=5 Participants
|
26.8 Score
STANDARD_DEVIATION 12.3 • n=7 Participants
|
26.4 Score
STANDARD_DEVIATION 11.5 • n=5 Participants
|
26.8 Score
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
UPDRS Score
Motor
|
10.6 Score
STANDARD_DEVIATION 6.7 • n=5 Participants
|
11.4 Score
STANDARD_DEVIATION 7.4 • n=7 Participants
|
10.8 Score
STANDARD_DEVIATION 5.5 • n=5 Participants
|
10.9 Score
STANDARD_DEVIATION 6.5 • n=4 Participants
|
|
UPDRS Score
Total
|
42.7 Score
STANDARD_DEVIATION 14.9 • n=5 Participants
|
43.1 Score
STANDARD_DEVIATION 19.0 • n=7 Participants
|
41.7 Score
STANDARD_DEVIATION 15.9 • n=5 Participants
|
42.5 Score
STANDARD_DEVIATION 16.6 • n=4 Participants
|
|
Schwab/England Activities of Daily Living Score ("On")
|
82.9 Score
STANDARD_DEVIATION 11.2 • n=5 Participants
|
80.3 Score
STANDARD_DEVIATION 14.6 • n=7 Participants
|
80.8 Score
STANDARD_DEVIATION 13.4 • n=5 Participants
|
81.3 Score
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Motor Fluctuations
Yes
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Motor Fluctuations
No
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
PDQ-39 Total
|
36.8 Score on PDQ-39 Questionnaire
STANDARD_DEVIATION 16.3 • n=5 Participants
|
37.2 Score on PDQ-39 Questionnaire
STANDARD_DEVIATION 15.6 • n=7 Participants
|
39.6 Score on PDQ-39 Questionnaire
STANDARD_DEVIATION 14.8 • n=5 Participants
|
37.9 Score on PDQ-39 Questionnaire
STANDARD_DEVIATION 15.6 • n=4 Participants
|
|
Short Form-36 Health Survey Scores
Physical Component Summary
|
37.5 Score
STANDARD_DEVIATION 9.3 • n=5 Participants
|
36.2 Score
STANDARD_DEVIATION 10.3 • n=7 Participants
|
37.1 Score
STANDARD_DEVIATION 10.4 • n=5 Participants
|
36.9 Score
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Short Form-36 Health Survey Scores
Mental Component Summary
|
41.4 Score
STANDARD_DEVIATION 8.8 • n=5 Participants
|
38.3 Score
STANDARD_DEVIATION 10.1 • n=7 Participants
|
40.0 Score
STANDARD_DEVIATION 9.3 • n=5 Participants
|
39.9 Score
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Snaith CAS
|
6.7 Score
STANDARD_DEVIATION 3.9 • n=5 Participants
|
7.8 Score
STANDARD_DEVIATION 4.5 • n=7 Participants
|
7.5 Score
STANDARD_DEVIATION 4.3 • n=5 Participants
|
7.3 Score
STANDARD_DEVIATION 4.2 • n=4 Participants
|
|
Mini Mental State Examination Score
|
28.7 Score
STANDARD_DEVIATION 1.4 • n=5 Participants
|
28.9 Score
STANDARD_DEVIATION 1.8 • n=7 Participants
|
28.5 Score
STANDARD_DEVIATION 1.5 • n=5 Participants
|
28.7 Score
STANDARD_DEVIATION 1.6 • n=4 Participants
|
|
BPRS Score
|
33.6 Score
STANDARD_DEVIATION 10.7 • n=5 Participants
|
35.7 Score
STANDARD_DEVIATION 8.9 • n=7 Participants
|
34.4 Score
STANDARD_DEVIATION 9.3 • n=5 Participants
|
34.6 Score
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Treatment of PD - Levodopa
Treatment - Yes
|
38 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Treatment of PD - Levodopa
Treatment - No
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Treatment of PD - Agonist
Treatment - Yes
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Treatment of PD - Agonist
Treatment - No
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Treatment for PD - Catechol O-methyltransferase Inhibitor
Treatment - Yes
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Treatment for PD - Catechol O-methyltransferase Inhibitor
Treatment - No
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Treatment of PD - Amantadine
Treatment - Yes
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Treatment of PD - Amantadine
Treatment - No
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Treatment of PD - Anticholinergic
Treatment - Yes
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Treatment of PD - Anticholinergic
Treatment - No
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
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.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Hamilton Depression Rating Scale (HAM-D) Scores
|
-13.0 Change in HAM-D score
Standard Deviation 1.3
|
-11.0 Change in HAM-D score
Standard Deviation 1.4
|
-6.8 Change in HAM-D score
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
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.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
|
-13.6 Change in MADRS score
Standard Error 1.2
|
-10.9 Change in MADRS score
Standard Error 1.3
|
-6.6 Change in MADRS score
Standard Error 1.2
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
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.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Beck Depression Inventory II (BDI-II)
|
-9.7 Change in BDI-II score
Standard Error 1.1
|
-9.6 Change in BDI-II score
Standard Error 1.2
|
-5.2 Change in BDI-II score
Standard Error 1.1
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Geriatric Depression Rating Scale (GDS)
|
-6.9 Change in GDS score
Standard Error 1.0
|
-6.9 Change in GDS score
Standard Error 1.1
|
-2.8 Change in GDS score
Standard Error 1.0
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Brief Psychiatric Rating Scale (BPRS)
|
-9.0 Change in BPRS score
Standard Error 1.3
|
-9.8 Change in BPRS score
Standard Error 1.4
|
-4.4 Change in BPRS score
Standard Error 1.3
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
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.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
|
-8.7 Change in UPDRS score
Standard Error 2.1
|
-7.0 Change in UPDRS score
Standard Error 2.3
|
-4.3 Change in UPDRS score
Standard Error 2.0
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Snaith Clinical Anxiety Scale (CAS)
|
-3.6 Change in CAS score
Standard Error 0.6
|
-3.2 Change in CAS score
Standard Error 0.6
|
-2.4 Change in CAS score
Standard Error 0.6
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI)
|
-2.1 Change in PQSI score
Standard Error 0.4
|
-2.6 Change in PQSI score
Standard Error 0.5
|
-1.1 Change in PQSI score
Standard Error 0.4
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
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.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
|
-4.3 Change in UPDRS-motor score
Standard Error 1.5
|
-2.0 Change in UPDRS-motor score
Standard Error 1.6
|
-1.0 Change in UPDRS-motor score
Standard Error 1.5
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
|
0.4 Change in UPDRS-tremor score
Standard Error 0.5
|
0.5 Change in UPDRS-tremor score
Standard Error 0.5
|
-0.6 Change in UPDRS-tremor score
Standard Error 0.5
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
|
-1.4 Change in UPDRS-Bulbar score
Standard Error 0.3
|
-1.4 Change in UPDRS-Bulbar score
Standard Error 0.3
|
-0.5 Change in UPDRS-Bulbar score
Standard Error 0.3
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
|
-8.0 Change in PDQ-39 score
Standard Error 2.3
|
-8.4 Change in PDQ-39 score
Standard Error 2.4
|
-5.3 Change in PDQ-39 score
Standard Error 2.1
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being
|
-21.4 Change in PDQ-39 Emotional score
Standard Error 3.3
|
-20.7 Change in PDQ-39 Emotional score
Standard Error 3.5
|
-10.9 Change in PDQ-39 Emotional score
Standard Error 3.1
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Short Form 36 Health Survey - Mental Component Summary
|
11.4 Change in SF-36 mental score
Standard Error 1.7
|
9.5 Change in SF-36 mental score
Standard Error 1.8
|
4.8 Change in SF-36 mental score
Standard Error 1.6
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Short Form 36 Health Survey - Vitality
|
13.5 Change in SF-36 vitality score
Standard Error 3.1
|
9.1 Change in SF-36 vitality score
Standard Error 3.3
|
4.7 Change in SF-36 vitality score
Standard Error 2.9
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Short Form 36 Health Survey - Role-Emotional
|
39.5 Change in SF-36 Role score
Standard Error 7.5
|
26.9 Change in SF-36 Role score
Standard Error 8.0
|
12.7 Change in SF-36 Role score
Standard Error 6.9
|
SECONDARY outcome
Timeframe: from the beginning (0 weeks) to end (12 weeks) of the double-blind phasePopulation: 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.
Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Outcome measures
| Measure |
Paroxetine
n=42 Participants
Mean change in outcome measure from baseline for participants taking paroxetine.
|
Venlafaxine Extended Release
n=34 Participants
Mean change in outcome measure from baseline for participants taking venlafaxine ER.
|
Placebo
n=39 Participants
Mean change in outcome measure from baseline for participants taking placebo.
|
|---|---|---|---|
|
Change in Short Form 36 Health Survey - Mental Health
|
16.7 Change in SF-36 Mental Health score
Standard Error 2.7
|
17.4 Change in SF-36 Mental Health score
Standard Error 2.8
|
9.7 Change in SF-36 Mental Health score
Standard Error 2.5
|
Adverse Events
Paroxetine
Venlafaxine Extended Release
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paroxetine
n=42 participants at risk
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
|
Venlafaxine Extended Release
n=34 participants at risk
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
|
Placebo
n=39 participants at risk
Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
2.4%
1/42 • Number of events 1
|
20.6%
7/34 • Number of events 7
|
23.1%
9/39 • Number of events 9
|
|
Psychiatric disorders
Abnormal Dreaming
|
2.4%
1/42 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
10.3%
4/39 • Number of events 4
|
|
Psychiatric disorders
Somnolence
|
19.0%
8/42 • Number of events 8
|
23.5%
8/34 • Number of events 8
|
12.8%
5/39 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
9.5%
4/42 • Number of events 4
|
11.8%
4/34 • Number of events 4
|
10.3%
4/39 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.1%
3/42 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
0.00%
0/39
|
|
Gastrointestinal disorders
Constipation
|
14.3%
6/42 • Number of events 6
|
20.6%
7/34 • Number of events 7
|
12.8%
5/39 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
14.3%
6/42 • Number of events 6
|
14.7%
5/34 • Number of events 5
|
12.8%
5/39 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
3/42 • Number of events 3
|
8.8%
3/34 • Number of events 3
|
7.7%
3/39 • Number of events 3
|
|
Reproductive system and breast disorders
Sexual Dysfunction
|
23.8%
10/42 • Number of events 10
|
23.5%
8/34 • Number of events 8
|
10.3%
4/39 • Number of events 4
|
|
General disorders
Fatigue
|
21.4%
9/42 • Number of events 9
|
11.8%
4/34 • Number of events 4
|
12.8%
5/39 • Number of events 5
|
|
General disorders
Back Pain
|
0.00%
0/42
|
5.9%
2/34 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Chest Pain
|
0.00%
0/42
|
5.9%
2/34 • Number of events 2
|
0.00%
0/39
|
|
General disorders
Hot Flushes
|
0.00%
0/42
|
0.00%
0/34
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
Tremor
|
16.7%
7/42 • Number of events 7
|
20.6%
7/34 • Number of events 7
|
7.7%
3/39 • Number of events 3
|
|
Nervous system disorders
Dyskinesia
|
2.4%
1/42 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
7.7%
3/39 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
16.7%
7/42 • Number of events 7
|
8.8%
3/34 • Number of events 3
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
Headache
|
14.3%
6/42 • Number of events 6
|
23.5%
8/34 • Number of events 8
|
15.4%
6/39 • Number of events 6
|
|
Nervous system disorders
Balance Difficulty
|
4.8%
2/42 • Number of events 2
|
8.8%
3/34 • Number of events 3
|
7.7%
3/39 • Number of events 3
|
|
Nervous system disorders
Numbness/Parasthesia
|
7.1%
3/42 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
10.3%
4/39 • Number of events 4
|
|
Nervous system disorders
Parkinsonism Aggravated
|
7.1%
3/42 • Number of events 3
|
14.7%
5/34 • Number of events 5
|
10.3%
4/39 • Number of events 4
|
|
Cardiac disorders
Hypertension
|
2.4%
1/42 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
0.00%
0/39
|
|
Renal and urinary disorders
Micturition Difficulty
|
11.9%
5/42 • Number of events 5
|
2.9%
1/34 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Weight Gain
|
0.00%
0/42
|
5.9%
2/34 • Number of events 2
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
4.8%
2/42 • Number of events 2
|
2.9%
1/34 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
0.00%
0/42
|
5.9%
2/34 • Number of events 2
|
7.7%
3/39 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/42 • Number of events 1
|
0.00%
0/34
|
12.8%
5/39 • Number of events 5
|
|
Psychiatric disorders
Irritability
|
2.4%
1/42 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
15.4%
6/39 • Number of events 6
|
|
Psychiatric disorders
Decreased Libido
|
7.1%
3/42 • Number of events 3
|
14.7%
5/34 • Number of events 5
|
5.1%
2/39 • Number of events 2
|
|
Psychiatric disorders
Marked Restlessness
|
7.1%
3/42 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
0.00%
0/39
|
Additional Information
Irene H. Richard, MD
University of Rochester Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place