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Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan

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ClinicalTrials.gov Identifier: NCT00330616
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : March 20, 2009
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder (MDD)
Intervention Drug: 323U66 SR
Enrollment 35

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupropion SR
Hide Arm/Group Description Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
Period Title: Overall Study
Started 35
Completed 14
Not Completed 21
Reason Not Completed
Adverse Event             13
Lack of Efficacy             1
Lost to Follow-up             2
Withdrawal by Subject             4
Not specified             1
Arm/Group Title Bupropion SR
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
73.5  (5.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
26
  74.3%
Male
9
  25.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 35 participants
35
1.Primary Outcome
Title Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-8.4  (10.34)
2.Secondary Outcome
Title Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Percentage of Change
-41.7  (25.40)
3.Secondary Outcome
Title Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Percentage of Change
-60.7  (30.54)
4.Secondary Outcome
Title Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Percentage of Responders
29.4
5.Secondary Outcome
Title Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Percentage of Responders
64.3
6.Secondary Outcome
Title Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Percentage of Remitters
17.6
7.Secondary Outcome
Title Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Percentage of Remitters
50.0
8.Secondary Outcome
Title Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Depressed Mood -1.4  (1.23)
Feelings of Guilt -0.7  (0.99)
Suicide -0.9  (1.03)
Insomnia Early -0.5  (0.87)
Insomnia Middle -0.5  (0.72)
Insomnia Late -0.6  (0.94)
Work/Activities -0.9  (1.17)
Retardation -1.2  (0.53)
Anxiety Psychic -0.9  (1.14)
Anxiety Somatic -0.8  (0.81)
Somatic Symptoms GI -0.3  (0.77)
Somatic Symptoms General -0.2  (0.90)
Genital Symptoms -0.5  (0.80)
Hypochondriasis -0.5  (0.94)
Lose Weight History -0.8  (0.88)
Insight -0.4  (0.62)
9.Secondary Outcome
Title Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Depressed Mood -1.9  (1.46)
Feelings of Guilt -1.0  (1.11)
Suicide -1.1  (0.92)
Insomnia Early -0.9  (0.86)
Insomnia Middle -0.6  (0.74)
Insomnia Late -0.9  (0.86)
Work/Activities -1.4  (1.50)
Retardation -1.4  (0.63)
Agitation -0.5  (0.94)
Anxiety Psychic -1.5  (1.34)
Anxiety Somatic -1.1  (0.86)
Somatic Symptoms GI -0.6  (0.84)
Somatic Symptoms General -0.8  (0.89)
Genital Symptoms -0.6  (0.93)
Hypochondriasis -0.9  (1.07)
Lose Weight History -1.1  (1.21)
Insight -0.4  (0.63)
10.Secondary Outcome
Title Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4
Hide Description The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Percentage of Change
Depressed Mood -47.1  (39.74)
Feelings of Guilt -76.7  (34.43)
Suicide -80.0  (36.84)
Insomnia Early -41.7  (59.67)
Insomnia Middle -40.6  (58.36)
Insomnia Late -42.9  (47.46)
Work/Activities -27.9  (31.86)
Retardation -73.5  (31.21)
Agitation -45.8  (68.28)
Anxiety Psychic -34.8  (43.72)
Anxiety Somatic -54.2  (39.67)
Somatic Symptoms GI -21.4  (57.89)
Somatic Symptoms General -17.9  (50.41)
Genital Symptoms -40.9  (62.52)
Hypochondriasis -38.1  (44.54)
Lose Weight History -57.7  (44.94)
Insight -60.0  (51.64)
11.Secondary Outcome
Title Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Percentage of Change
Depressed Mood -60.7  (40.62)
Feelings of Guilt -100.0  (0)
Suicide -83.3  (32.57)
Insomnia Early -70.0  (42.16)
Insomnia Middle -50.0  (61.24)
Insomnia Late -68.2  (46.22)
Work/Activities -42.3  (46.74)
Retardation -78.6  (32.31)
Agitation -52.8  (77.76)
Anxiety Psychic -55.4  (48.88)
Anxiety Somatic -60.7  (55.32)
Somatic Symptoms GI -45.8  (62.01)
Somatic Symptoms General -50.0  (60.30)
Genital Symptoms -45.5  (65.02)
Hypochondriasis -50.0  (43.23)
Lose Weight History -81.8  (33.71)
Insight -50.0  (70.71)
12.Secondary Outcome
Title Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8
Hide Description The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4 17.3  (6.94)
Week 8 15.7  (8.41)
13.Secondary Outcome
Title Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8
Hide Description The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.
Time Frame Week 4 and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Percentage of Responders
Week 4 24.2
Week 8 42.4
14.Secondary Outcome
Title Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8
Hide Description The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame Baseline, Weeks 1, 2, 3, 4, 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1 -0.2  (0.63)
Week 2 -0.4  (0.73)
Week 3 -0.4  (0.86)
Week 4 -0.6  (0.99)
Week 8 -0.9  (1.22)
15.Secondary Outcome
Title Adverse Events (>=5% Incidence)
Hide Description [Not Specified]
Time Frame Baseline through Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population - all subjects who took at least one dose of study medication.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
Nausea 6
Constipation 5
Dizziness 5
Nasopharyngitis 4
Pyrexia 3
Thirst 3
Weight Decreased 3
Glossitis 2
Paraesthesia Oral 2
Vomiting 2
Irritability 2
Oedema Peripheral 2
Somnolence 2
Blood Pressure Increased 2
Pruritus 2
Depression 2
Excoriation 2
Back Pain 2
16.Secondary Outcome
Title Serious Adverse Events
Hide Description [Not Specified]
Time Frame Baseline through Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population - all subjects who took at least one dose of study medication.
Arm/Group Title Bupropion SR
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion SR
Hide Arm/Group Description Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
All-Cause Mortality
Bupropion SR
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bupropion SR
Affected / at Risk (%) # Events
Total   1    
Psychiatric disorders   
Suicide attempt  1  1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bupropion SR
Affected / at Risk (%) # Events
Total   31    
Blood and lymphatic system disorders   
Edema Peripheral  1  2/35 (5.71%) 
Cardiac disorders   
Blood Pressure increased  1  2/35 (5.71%) 
Gastrointestinal disorders   
Nausea  1  6/35 (17.14%) 
Constipation  1  5/35 (14.29%) 
Glossitis  1  2/35 (5.71%) 
Vomiting  1  2/35 (5.71%) 
General disorders   
Pyrexia  1  3/35 (8.57%) 
Thirst  1  3/35 (8.57%) 
Pruritus  1  2/35 (5.71%) 
Back Pain  1  2/35 (5.71%) 
Metabolism and nutrition disorders   
Weight decrease  1  3/35 (8.57%) 
Nervous system disorders   
Dizziness  1  5/35 (14.29%) 
Paraesthesia oral  1  2/35 (5.71%) 
Psychiatric disorders   
Irritability  1  2/35 (5.71%) 
Somnolence  1  2/35 (5.71%) 
Depression  1  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders   
Nasopharyngitis  1  4/35 (11.43%) 
Skin and subcutaneous tissue disorders   
Excoriation  1  2/35 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00330616     History of Changes
Other Study ID Numbers: AK1102369
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: November 26, 2008
Results First Posted: March 20, 2009
Last Update Posted: May 4, 2015