Trial Outcomes & Findings for The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression (NCT NCT00125957)
NCT ID: NCT00125957
Last Updated: 2014-08-06
Results Overview
Median total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.
COMPLETED
PHASE3
32 participants
Baseline and follow-up
2014-08-06
Participant Flow
Participant milestones
| Measure |
Wellbutrin First, Then Placebo
Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
|
Placebo First, Then Wellbutrin
Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.
|
|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
15
|
17
|
|
First Intervention (3 Weeks)
COMPLETED
|
15
|
17
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (3 Weeks)
STARTED
|
15
|
17
|
|
Second Intervention (3 Weeks)
COMPLETED
|
15
|
17
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression
Baseline characteristics by cohort
| Measure |
Wellbutrin-Placebo
n=15 Participants
Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
|
Placebo-Wellbutrin
n=17 Participants
Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
47 years
n=7 Participants
|
48 years
n=5 Participants
|
|
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
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and follow-upMedian total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.
Outcome measures
| Measure |
Wellbutrin First, Then Placebo
n=15 Participants
Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
|
Placebo First, Then Wellbutrin
n=17 Participants
Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline
|
22.0 units on a scale
Interval 19.0 to 24.0
|
18.0 units on a scale
Interval 9.0 to 21.0
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Follow-up at week 4
|
12.0 units on a scale
Interval 8.0 to 21.0
|
14.0 units on a scale
Interval 5.0 to 19.0
|
PRIMARY outcome
Timeframe: Baseline and follow-upMedian total depression ratings at baseline and follow-up using the HAM-D. The scale consists of 21 questions that assess depression symptoms. Questions 1-3, 7-11, 15, and 19 are rated on a scale of 0-4, with 0 being not present to and 4 being severe. Questions 4, 5, 12 - 14, 16-18 and 21 are rated from 0-2 with a score of 0 signifying the symptom is absent and a score of 2 as most severe. Item 20 is score on a scale of 0-3 with the same pattern of severity as all other questions. The total score for the HAM-D ranges from 0-63.
Outcome measures
| Measure |
Wellbutrin First, Then Placebo
n=15 Participants
Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
|
Placebo First, Then Wellbutrin
n=17 Participants
Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
Baseline
|
21.5 units on a scale
Interval 16.0 to 29.0
|
14 units on a scale
Interval 9.0 to 18.0
|
|
Hamilton Depression Rating Scale (HAM-D)
Follow-up at week 4
|
13.5 units on a scale
Interval 8.0 to 17.0
|
14 units on a scale
Interval 8.0 to 18.0
|
Adverse Events
Bupropion-Placebo
Placebo-Bupropion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place