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The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression

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ClinicalTrials.gov Identifier: NCT00125957
Recruitment Status : Completed
First Posted : August 2, 2005
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
National Association for Research on Schizophrenia and Affective Disorders.
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Depression
Major Depressive Disorder
Unipolar Depression
Interventions Drug: Wellbutrin
Drug: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wellbutrin First, Then Placebo Placebo First, Then Wellbutrin
Hide Arm/Group Description 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. 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.
Period Title: First Intervention (3 Weeks)
Started 15 17
Completed 15 17
Not Completed 0 0
Period Title: Second Intervention (3 Weeks)
Started 15 17
Completed 15 17
Not Completed 0 0
Arm/Group Title Wellbutrin-Placebo Placebo-Wellbutrin Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
49
(18 to 65)
47
(22 to 63)
48
(18 to 65)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  93.3%
17
 100.0%
31
  96.9%
>=65 years
1
   6.7%
0
   0.0%
1
   3.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
9
  60.0%
8
  47.1%
17
  53.1%
Male
6
  40.0%
9
  52.9%
15
  46.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 17 participants 32 participants
15 17 32
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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.
Time Frame Baseline and follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wellbutrin First, Then Placebo Placebo First, Then Wellbutrin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 17
Mean (Full Range)
Unit of Measure: units on a scale
Baseline
22.0
(19.0 to 24.0)
18.0
(9.0 to 21.0)
Follow-up at week 4
12.0
(8.0 to 21.0)
14.0
(5.0 to 19.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wellbutrin First, Then Placebo, Placebo First, Then Wellbutrin
Comments Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Hamilton Depression Rating Scale (HAM-D)
Hide Description Median 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.
Time Frame Baseline and follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wellbutrin First, Then Placebo Placebo First, Then Wellbutrin
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 15 17
Median (Full Range)
Unit of Measure: units on a scale
Baseline
21.5
(16 to 29)
14
(9 to 18)
Follow-up at week 4
13.5
(8 to 17)
14
(8 to 18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wellbutrin First, Then Placebo, Placebo First, Then Wellbutrin
Comments Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion-Placebo Placebo-Bupropion
Hide Arm/Group Description Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg BID bupropion) 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. 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 bupropion 100 mg 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.
All-Cause Mortality
Bupropion-Placebo Placebo-Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bupropion-Placebo Placebo-Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupropion-Placebo Placebo-Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Beth Murphy
Organization: McLean Hospital
Phone: 617-855-2000 ext 2297
Responsible Party: Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00125957     History of Changes
Other Study ID Numbers: 2005P-000502
First Submitted: August 1, 2005
First Posted: August 2, 2005
Results First Submitted: June 11, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 6, 2014