Trial Outcomes & Findings for Wellbutrin XL for Dysthymic Disorder (NCT NCT00225251)
NCT ID: NCT00225251
Last Updated: 2015-11-26
Results Overview
Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue. This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
10 weeks
Results posted on
2015-11-26
Participant Flow
Participant milestones
| Measure |
Bupropion XL
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Bupropion XL
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Wellbutrin XL for Dysthymic Disorder
Baseline characteristics by cohort
| Measure |
Bupropion XL
n=11 Participants
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 Participants
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksWidely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue. This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7)
Outcome measures
| Measure |
Bupropion XL
n=11 Participants
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 Participants
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Hamilton Depression Rating Scale, 24 Items (HDRS)
|
14.4 units on a scale
Standard Deviation 6.9
|
13.3 units on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 10 weeksA 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
Outcome measures
| Measure |
Bupropion XL
n=11 Participants
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 Participants
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Cornell Dysthymia Rating Scale (CDRS)
|
26.4 units on a scale
Standard Deviation 10.8
|
24 units on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 10 weeks21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Outcome measures
| Measure |
Bupropion XL
n=11 Participants
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 Participants
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Beck Depression Inventory (BDI)
|
8 units on a scale
Standard Deviation 4.4
|
12.3 units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 10 weeksA global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
Outcome measures
| Measure |
Bupropion XL
n=11 Participants
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 Participants
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Clinical Global Improvement (CGI)
|
2.8 units on a scale
Standard Deviation 1
|
2.43 units on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 10 weeksA clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Outcome measures
| Measure |
Bupropion XL
n=11 Participants
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 Participants
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Global Assessment of Functioning Scale (GAFS)
|
64 units on a scale
Standard Deviation 8.6
|
67 units on a scale
Standard Deviation 9.6
|
Adverse Events
Bupropion XL
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion XL
n=11 participants at risk
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
bupropion XL: Antidepressant medication
|
Placebo
n=7 participants at risk
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
|
|---|---|---|
|
Nervous system disorders
headache
|
36.4%
4/11 • Number of events 4 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
0.00%
0/7 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
|
Gastrointestinal disorders
dry mouth
|
27.3%
3/11 • Number of events 3 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
0.00%
0/7 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
|
Nervous system disorders
dizziness
|
18.2%
2/11 • Number of events 2 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
0.00%
0/7 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
|
Nervous system disorders
insomnia
|
9.1%
1/11 • Number of events 1 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
42.9%
3/7 • Number of events 3 • 10 weeks
patients were assessed for side effects over the course of the efficacy study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place