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Wellbutrin XL for Dysthymic Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225251
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : November 24, 2014
Last Update Posted : November 26, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dysthymic Disorder
Interventions Drug: bupropion XL
Other: Placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Period Title: Overall Study
Started 11 7
Completed 10 6
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Bupropion XL Placebo Total
Hide Arm/Group Description

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day Total of all reporting groups
Overall Number of Baseline Participants 11 7 18
Hide Baseline Analysis Population Description
adults with dysthymic disorder, males and females
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 7 participants 18 participants
40.6  (11.5) 40.0  (10.9) 40.3  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 7 participants 18 participants
Female
7
  63.6%
4
  57.1%
11
  61.1%
Male
4
  36.4%
3
  42.9%
7
  38.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 7 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  27.3%
1
  14.3%
4
  22.2%
White
8
  72.7%
6
  85.7%
14
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 7 participants 18 participants
11 7 18
1.Primary Outcome
Title Hamilton Depression Rating Scale, 24 Items (HDRS)
Hide Description

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)

Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description:

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.4  (6.9) 13.3  (8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupropion XL, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Cornell Dysthymia Rating Scale (CDRS)
Hide Description A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description:

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.4  (10.8) 24  (14)
3.Secondary Outcome
Title Beck Depression Inventory (BDI)
Hide Description 21 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.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description:

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
8  (4.4) 12.3  (10.1)
4.Secondary Outcome
Title Clinical Global Improvement (CGI)
Hide Description A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description:

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (1) 2.43  (1)
5.Secondary Outcome
Title Global Assessment of Functioning Scale (GAFS)
Hide Description A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description:

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Overall Number of Participants Analyzed 11 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
64  (8.6) 67  (9.6)
Time Frame 10 weeks
Adverse Event Reporting Description patients were assessed for side effects over the course of the efficacy study
 
Arm/Group Title Bupropion XL Placebo
Hide Arm/Group Description

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

bupropion XL: Antidepressant medication

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
All-Cause Mortality
Bupropion XL Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Bupropion XL Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bupropion XL Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/11 (54.55%)      3/7 (42.86%)    
Gastrointestinal disorders     
dry mouth * [1]  3/11 (27.27%)  3 0/7 (0.00%)  0
Nervous system disorders     
headache * [2]  4/11 (36.36%)  4 0/7 (0.00%)  0
dizziness * [3]  2/11 (18.18%)  2 0/7 (0.00%)  0
insomnia * [4]  1/11 (9.09%)  1 3/7 (42.86%)  3
*
Indicates events were collected by non-systematic assessment
[1]
patient reported dry mouth
[2]
patient reported headache
[3]
patient reported dizziness
[4]
reported difficulty sleeping
Early termination led to small numbers of subjects analyzed
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
Layout table for Results Point of Contact information
Name/Title: David Hellerstein MD
Organization: NY State Psychiatric Institute
Phone: 6467748000
EMail: hellers@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00225251    
Other Study ID Numbers: gsk 102149
First Submitted: September 21, 2005
First Posted: September 23, 2005
Results First Submitted: May 13, 2014
Results First Posted: November 24, 2014
Last Update Posted: November 26, 2015