Trial Outcomes & Findings for Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease (NCT NCT00304161)
NCT ID: NCT00304161
Last Updated: 2017-01-30
Results Overview
The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a \>50% decrease in IDS-C score from baseline.
COMPLETED
PHASE4
55 participants
Week 8
2017-01-30
Participant Flow
Patients were recruited from The Parkinson's Disease and Movement Disorders Center at Pennsylvania Hospital and the Parkinson's Disease Research, Education, and Clinical Center at the Philadelphia Veterans Affairs Medical Center between 2004-2009.
Participant milestones
| Measure |
Atomoxetine
Participants will receive 40-80mgs of atomoxetine orally once daily.
|
Placebo
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=28 Participants
Participants will receive atomoxetine treatment
|
Placebo
n=27 Participants
Participants will receive placebo treatment
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Gender
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology-Clinician Rated (IDS-C), a 30-item (scores 0-84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a \>50% decrease in IDS-C score from baseline.
Outcome measures
| Measure |
Atomoxetine
n=22 Participants
Participants will receive 40-80mgs of atomoxetine orally once daily.
|
Placebo
n=21 Participants
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
|
|---|---|---|
|
Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale
|
22.7 percentage of improved participants
|
9.5 percentage of improved participants
|
SECONDARY outcome
Timeframe: Week 8The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse A participant scoring a 1 or 2 is considered a responder on the CGI scale.
Outcome measures
| Measure |
Atomoxetine
n=22 Participants
Participants will receive 40-80mgs of atomoxetine orally once daily.
|
Placebo
n=21 Participants
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
|
|---|---|---|
|
Clinical Global Impression-Improvement Scale
|
45.5 percentage of responders
|
33.3 percentage of responders
|
Adverse Events
Atomoxetine
Placebo
Serious adverse events
| Measure |
Atomoxetine
n=28 participants at risk
Participants will receive 40-80mgs of atomoxetine orally once daily.
|
Placebo
n=27 participants at risk
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
|
|---|---|---|
|
Psychiatric disorders
Suicide Ideation
|
3.6%
1/28
|
0.00%
0/27
|
|
Cardiac disorders
Congestive Heart Failure
|
3.6%
1/28
|
0.00%
0/27
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/28
|
3.7%
1/27
|
|
Renal and urinary disorders
Urosepsis
|
0.00%
0/28
|
3.7%
1/27
|
Other adverse events
| Measure |
Atomoxetine
n=28 participants at risk
Participants will receive 40-80mgs of atomoxetine orally once daily.
|
Placebo
n=27 participants at risk
Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
7/28
|
3.7%
1/27
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/28
|
18.5%
5/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place