Trial Outcomes & Findings for Treatment of Depression in Parkinson's Disease Trial (NCT NCT00062738)
NCT ID: NCT00062738
Last Updated: 2015-11-24
Results Overview
total score on HDRS (0-54 higher score is worse)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
8 weeks
Results posted on
2015-11-24
Participant Flow
Patients were recruited between 10/2003 and 7/2007, from the RWJMS movement disorder clinic and advertising to local support groups.
Patients who met inclusion and not exclusion criteria were enrolled.
Participant milestones
| Measure |
Nortriptyline
Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
|
Paroxetine
Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. .
|
Placebo
Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Depression in Parkinson's Disease Trial
Baseline characteristics by cohort
| Measure |
Nortriptyline
n=17 Participants
Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
|
Paroxetine
n=18 Participants
Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
|
Placebo
n=17 Participants
Placebo was started at 1 pill and could be increased up to three pills.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
62.8 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 9.2 • n=27 Participants
|
62.2 years
STANDARD_DEVIATION 8.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
18 participants
n=4 Participants
|
17 participants
n=27 Participants
|
52 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: intent to treat - total patients in the arm
total score on HDRS (0-54 higher score is worse)
Outcome measures
| Measure |
Nortriptyline
n=17 Participants
|
Paroxetine
n=18 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
Hamilton Depression Scale
|
10.84 units on a scale
Standard Deviation 6.2
|
12.45 units on a scale
Standard Deviation 6.36
|
15.81 units on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: intent to treat
Percent of patients who had a 50% decrease in total HDRS at 8 weeks
Outcome measures
| Measure |
Nortriptyline
n=17 Participants
|
Paroxetine
n=18 Participants
|
Placebo
n=17 Participants
|
|---|---|---|---|
|
Percent Responders
|
53 percent of patients who were responders
|
11 percent of patients who were responders
|
24 percent of patients who were responders
|
Adverse Events
Nortriptyline
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Paroxetine
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nortriptyline
n=17 participants at risk
|
Paroxetine
n=18 participants at risk
|
Placebo
n=17 participants at risk
|
|---|---|---|---|
|
Nervous system disorders
fainting
|
0.00%
0/17 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
5.6%
1/18 • Number of events 1 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
0.00%
0/17 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
Nervous system disorders
muscle rigidity
|
0.00%
0/17 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
0.00%
0/18 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
5.9%
1/17 • Number of events 1 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
Nervous system disorders
delirium
|
0.00%
0/17 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
0.00%
0/18 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
5.9%
1/17 • Number of events 1 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
Other adverse events
| Measure |
Nortriptyline
n=17 participants at risk
|
Paroxetine
n=18 participants at risk
|
Placebo
n=17 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
35.3%
6/17 • Number of events 6 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
5.6%
1/18 • Number of events 1 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
5.9%
1/17 • Number of events 1 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
Gastrointestinal disorders
dry mouth
|
41.2%
7/17 • Number of events 7 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
5.6%
1/18 • Number of events 1 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
0.00%
0/17 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
Nervous system disorders
insomnia
|
11.8%
2/17 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
0.00%
0/18 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
23.5%
4/17 • Number of events 4 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
General disorders
fatigue
|
0.00%
0/17 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
16.7%
3/18 • Number of events 3 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
11.8%
2/17 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
Cardiac disorders
orthostatic hypotension
|
11.8%
2/17 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
11.1%
2/18 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
11.8%
2/17 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
|
Cardiac disorders
dizziness
|
11.8%
2/17 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
0.00%
0/18 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
11.8%
2/17 • Number of events 2 • All data were collected between 10/2003 and 7/2007. Data were collected on each individual for the eight week trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place