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Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors

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ClinicalTrials.gov Identifier: NCT00296517
Recruitment Status : Completed
First Posted : February 27, 2006
Results First Posted : July 16, 2009
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder
Interventions Drug: 323U66 (Bupropion Hydrochloride Sustained Release)
Drug: Placebo
Enrollment 325
Recruitment Details  
Pre-assignment Details

Pre-treatment period: Paroxetine 40 mg/day was administered for four weeks in subjects treated with marketed paroxetine between doses of 20 and 40 mg/day for four weeks or more prior to tapering pretreatment period.

Tapering pretreatment period: Paroxetine was tapered down weekly by 10 mg/day in subjects who were progressed to treatment period.

Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period. Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Period Title: Dose Level 1 - Week 1
Started 159 166
Completed 159 166
Not Completed 0 0
Period Title: Dose Level 2 - Week 2
Started 159 166
Completed 157 161
Not Completed 2 5
Reason Not Completed
Adverse Event             1             5
Withdrawal by Subject             1             0
Period Title: Dose Level 3 - Weeks 3-12
Started 157 161
Completed 112 99
Not Completed 45 62
Reason Not Completed
Adverse Event             30             34
Lack of Efficacy             3             6
Lost to Follow-up             3             2
Protocol Violation             1             0
Withdrawal by Subject             7             18
Non - Compliance             1             0
Not specified             0             2
Arm/Group Title Placebo Bupropion SR Total
Hide Arm/Group Description Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period. Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg. Total of all reporting groups
Overall Number of Baseline Participants 157 165 322
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 165 participants 322 participants
36.0  (8.91) 36.8  (9.28) 36.4  (9.10)
[1]
Measure Description: The Full Analysis Set (all subjects who entered the treatment phase, with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment) for Baseline Characteristic measures.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 165 participants 322 participants
Female
69
  43.9%
77
  46.7%
146
  45.3%
Male
88
  56.1%
88
  53.3%
176
  54.7%
[1]
Measure Description: The Full Analysis Set (all subjects who entered the treatment phase, with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment) for Baseline Characteristic measures.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 157 participants 165 participants 322 participants
157 165 322
[1]
Measure Description: The Full Analysis Set (all subjects who entered the treatment phase, with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment) for Baseline Characteristic measures.
1.Primary Outcome
Title Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
Hide Description The Hamilton Rating Scale for Depression 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 52 (severely ill).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: Score in scale
Baseline 19.8  (4.34) 19.4  (4.39)
Week 12 or Last Observation Carried Forward 14.7  (8.89) 14.6  (9.09)
Change from Baseline -5.1  (8.02) -4.9  (8.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bupropion SR
Comments Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval 95%
-1.6 to 2.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Hamilton Depression Scale (HAM-D 17 Items) Total Score
Hide Description The Hamilton Rating Scale for Depression 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 52 (severely ill).
Time Frame Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: Score in scale
Week 8 Mean - Last Observation Carried Forward 15.8  (8.04) 15.4  (8.32)
Week 8 Mean - Observed Cases 13.3  (6.74) 12.1  (6.28)
Week 12 Mean - Observed Cases 11.3  (7.09) 10.3  (6.83)
3.Secondary Outcome
Title Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
Hide Description The Hamilton Rating Scale for Depression 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 52 (severely ill).
Time Frame Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: Score in a scale
Week 8 Mean - Last Observation Carried Forward -4.1  (7.07) -4.0  (7.60)
Week 8 Mean - Observed Cases -6.4  (5.77) -7.4  (5.75)
Week 12 Mean - Observed Cases -8.3  (6.38) -9.2  (5.98)
4.Secondary Outcome
Title Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
Hide Description The Hamilton Rating Scale for Depression 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 52 (severely ill).
Time Frame Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: Percent Change in score
Week 8 Mean - Last Observation Carried Forward -21.0  (37.31) -20.8  (38.87)
Week 8 Mean - Observed Cases -33.2  (30.51) -38.2  (28.68)
Week 12 Mean - Last Observation Carried Forward -26.5  (41.65) -25.5  (43.05)
Week 12 Mean - Observed Cases -43.0  (32.51) -48.4  (29.96)
5.Secondary Outcome
Title Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Hide Description The Hamilton Rating Scale for Depression 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 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.
Time Frame Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Responders
Week 8 Mean Last Observation Carried Forward
24
(17.8 to 32.0)
26
(19.1 to 33.1)
Week 8 Mean Observed Cases
31
(22.6 to 40.4)
38
(28.5 to 47.7)
Week 12 Mean Last Observation Carried Forward
37
(29.8 to 45.5)
38
(30.6 to 46.1)
Week 12 Mean Observed Cases
50
(40.8 to 60.1)
59
(48.8 to 69.0)
6.Secondary Outcome
Title Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
Hide Description The Hamilton Rating Scale for Depression 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 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.
Time Frame Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Remitters
Week 8 Mean Last Observation Carried Forward
18
(12.0 to 24.8)
18
(12.5 to 25.0)
Week 8 Mean Observed Cases
22
(14.9 to 30.9)
26
(18.3 to 35.9)
Week 12 Mean Last Observation Carried Forward
25
(18.5 to 32.8)
24
(17.4 to 31.1)
Week 12 Mean Observed Cases
33
(24.7 to 42.9)
38
(28.2 to 48.1)
7.Secondary Outcome
Title Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Hide Description The Hamilton Rating Scale for Depression 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 scores ranging from 0 (not ill) to 54 (severely ill).
Time Frame Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: points on a scale
Depressed Mood, Week 8 Mean LOCF -0.5  (1.07) -0.5  (1.20)
Depressed Mood, Week 12 Mean LOCF -0.6  (1.17) -0.6  (1.30)
Feelings of Guilt, Week 8 Mean LOCF -0.3  (0.91) -0.3  (0.75)
Feelings of Guilt, Week 12 Mean LOCF -0.3  (0.90) -0.4  (0.77)
Suicide, Week 8 Mean LOCF -0.1  (0.82) -0.1  (0.73)
Suicide, Week 12 Mean LOCF -0.1  (0.82) -0.1  (0.72)
Insomnia Early, Week 8 Mean LOCF -0.3  (0.83) -0.3  (0.82)
Insomnia Early, Week 12 Mean LOCF -0.4  (0.85) -0.3  (0.89)
Insomnia Middle, Week 8 Mean LOCF -0.4  (0.87) -0.3  (0.73)
Insomnia Middle, Week 12 Mean LOCF -0.4  (0.91) -0.3  (0.79)
Insomnia Late, Week 8 Mean LOCF -0.3  (0.87) -0.3  (0.78)
Insomnia Late, Week 12 Mean LOCF -0.3  (0.91) -0.4  (0.88)
Work and Activities, Week 8 Mean LOCF -0.4  (0.93) -0.4  (1.18)
Work and Activities, Week 12 Mean LOCF -0.6  (1.13) -0.5  (1.35)
Retardation, Week 8 Mean LOCF -0.2  (0.69) -0.2  (0.68)
Retardation, Week 12 Mean LOCF -0.3  (0.78) -0.3  (0.73)
Agitation, Week 8 Mean LOCF -0.2  (0.68) -0.2  (0.77)
Agitation, Week 12 Mean LOCF -0.3  (0.77) -0.2  (0.77)
Anxiety Psychic, Week 8 Mean LOCF -0.3  (1.16) -0.4  (1.10)
Anxiety Psychic, Week 12 Mean LOCF -0.5  (1.26) -0.5  (1.19)
Anxiety Somatic, Week 8 Mean LOCF -0.2  (0.88) -0.3  (0.92)
Anxiety Somatic, Week 12 Mean LOCF -0.3  (0.89) -0.4  (0.99)
Somatic Symptoms GI, Week 8 Mean LOCF -0.1  (0.61) 0.0  (0.74)
Somatic Symptoms GI, Week 12 Mean LOCF -0.1  (0.64) -0.0  (0.80)
Somatic Symptoms General, Week 8 Mean LOCF -0.2  (0.65) -0.2  (0.69)
Somatic Symptoms General, Week 12 Mean LOCF -0.2  (0.71) -0.3  (0.71)
Genital Symptoms, Week 8 Mean LOCF -0.2  (0.58) -0.2  (0.62)
Genital Symptoms, Week 12 Mean LOCF -0.2  (0.66) -0.3  (0.71)
Hypochondriasis, Week 8 Mean LOCF -0.2  (0.77) -0.1  (0.84)
Hypochondriasis, Week 12 Mean LOCF -0.3  (0.78) -0.2  (0.89)
Loss of Weight by History, Week 8 Mean LOCF -0.1  (0.60) -0.0  (0.58)
Loss of Weight by History, Week 12 Mean LOCF -0.1  (0.63) 0.0  (0.64)
Insight, Week 8 Mean LOCF -0.1  (0.34) -0.1  (0.41)
Insight, Week 12 Mean LOCF -0.1  (0.38) -0.1  (0.45)
8.Secondary Outcome
Title Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
Hide Description The Hamilton Rating Scale for Depression 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 scores ranging from 0 (not ill) to 54 (severely ill).
Time Frame Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: percent change in score
Depressed Mood, Week 8 Mean LOCF, n=152, 158 -17.7  (60.38) -18.5  (62.38)
Depressed Mood, Week 12 Mean LOCF, n=155, 158 -25.9  (62.78) -22.2  (68.41)
Feelings of Guilt, Week 8 Mean LOCF, n=128, 131 -24.9  (55.10) -25.8  (52.83)
Feelings of Guilt, Week 12 Mean LOCF, n=129, 131 -30.7  (56.34) -30.8  (53.61)
Suicide, Week 8 Mean LOCF, n=79, 75 -34.2  (60.20) -26.7  (70.87)
Suicide, Week 12 Mean LOCF, n=80, 75 -37.5  (56.53) -26.0  (74.14)
Insomnia Early, Week 8 Mean LOCF, n=112, 119 -34.8  (53.20) -29.8  (54.59)
Insomnia Early, Week 12 Mean LOCF, n=114, 119 -42.5  (53.73) -31.9  (58.49)
Insomnia Middle, Week 8 Mean LOCF, n=119, 124 -42.0  (53.28) -32.3  (51.48)
Insomnia Middle, Week 12 Mean LOCF, n=122, 124 -48.4  (54.90) -37.1  (54.43)
Insomnia Late, Week 8 Mean LOCF, n=109, 117 -39.9  (56.43) -31.6  (54.38)
Insomnia Late, Week 12 Mean LOCF, n=110, 117 -43.2  (61.88) -37.2  (62.34)
Work and Activities, Week 8 Mean LOCF, n=151, 156 -16.6  (43.93) -15.3  (55.66)
Work and Activities, Week 12 Mean LOCF, n=154, 156 -23.3  (47.61) -19.4  (62.51)
Retardation, Week 8 Mean LOCF, n=114, 124 -28.4  (58.70) -31.0  (53.19)
Retardation, Week 12 Mean LOCF, n=117, 124 -32.5  (63.08) -38.3  (56.71)
Agitation, Week 8 Mean LOCF, n=87, 99 -38.7  (61.87) -44.9  (60.40)
Agitation, Week 12 Mean LOCF, n=89, 99 -51.1  (64.83) -44.9  (63.28)
Anxiety Psychic, Week 8 Mean LOCF, n=146, 151 -14.0  (58.25) -17.9  (55.14)
Anxiety Psychic, Week 12 Mean LOCF, n=148, 151 -19.1  (62.70) -21.0  (66.45)
Anxiety Somatic, Week 8 Mean LOCF, n=144, 155 -9.5  (57.89) -13.9  (60.12)
Anxiety Somatic, Week 12 Mean LOCF, n=147, 155 -13.7  (59.35) -17.7  (63.07)
Somatic Symptoms GI, Week 8 Mean LOCF, n=95, 93 -30.5  (56.16) -25.8  (63.68)
Somatic Symptoms GI, Week 12 Mean LOCF, n=97, 93 -23.7  (62.12) -34.9  (65.02)
Somatic Symptoms Gen., Week 8 Mean LOCF, n=146,152 -13.4  (50.61) -18.8  (48.08)
Som. Symptoms Gen., Week 12 Mean LOCF, n=149, 152 -15.8  (54.55) -23.7  (51.13)
Genital Symptoms, Week 8 Mean LOCF, n=115, 129 -15.2  (45.97) -21.7  (45.86)
Genital Symptoms, Week 12 Mean LOCF, n=118, 129 -16.5  (51.50) -29.5  (50.24)
Hypochondriasis, Week 8 Mean LOCF, n=93, 102 -34.6  (55.78) -28.3  (63.70)
Hypochondriasis, Week 12 Mean LOCF, n=95, 102 -38.6  (56.82) -38.1  (66.27)
Loss of Weight by Hist., W 8 Mean LOCF, n=32, 26 -60.9  (45.32) -51.9  (57.41)
Loss of Weight by Hist., W 12 Mean LOCF, n=34, 26 -58.8  (48.42) -57.7  (57.78)
Insight, Week 8 Mean LOCF, n=48, 51 -27.1  (44.91) -41.2  (49.71)
Insight, Week 12 Mean LOCF, n=49, 51 -36.7  (48.71) -47.1  (50.41)
9.Secondary Outcome
Title Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
Hide Description The 7-point Clinical Global Impressions–Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.
Time Frame Baseline to Weeks 1, 2, 3, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (Standard Deviation)
Unit of Measure: Points on scale
Week 1 Mean LOCF, n=157, 165 -0.0  (0.45) 0.0  (0.51)
Week 1 Mean OC, n=139, 143 -0.1  (0.40) -0.0  (0.45)
Week 2 Mean LOCF, n=157, 165 -0.1  (0.63) -0.1  (0.71)
Week 2 Mean OC, n=134, 132 -0.2  (0.59) -0.3  (0.66)
Week 3 Mean LOCF, n=157, 165 -0.2  (0.71) -0.2  (0.73)
Week 3 Mean OC, n=130, 127 -0.3  (0.61) -0.4  (0.65)
Week 4 Mean LOCF, n=157, 165 -0.2  (0.76) -0.2  (0.83)
Week 4 Mean OC, n=127, 116 -0.4  (0.65) -0.4  (0.77)
Week 8 Mean LOCF, n=157, 164 -0.5  (1.02) -0.5  (1.01)
Week 8 Mean OC, n=113, 106 -0.7  (0.87) -0.9  (0.85)
Week 12 Mean LOCF, n=157, 163 -0.6  (1.12) -0.6  (1.15)
Week 12 Mean OC, n=111, 98 -0.9  (0.90) -1.1  (0.98)
10.Secondary Outcome
Title Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
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 Baseline to Week 8 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Responders
Week 8 Mean Last Observation Carried Forward
33
(25.9 to 41.4)
38
(30.8 to 46.4)
Week 8 Mean Observed Cases
42
(32.4 to 51.2)
57
(46.6 to 66.2)
Week 12 Mean Last Observation Carried Forward
44
(35.7 to 51.8)
48
(40.1 to 56.2)
Week 12 Mean Observed Cases
57
(47.0 to 66.1)
73
(63.6 to 81.9)
11.Secondary Outcome
Title Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12
Hide Description Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 157 165
Measure Type: Number
Unit of Measure: participants
Participants at risk 102 90
Participants not at risk 55 75
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Bupropion SR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
12.Secondary Outcome
Title Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Hide Description Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description:
Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
Overall Number of Participants Analyzed 159 166
Measure Type: Number
Unit of Measure: Number of events
Nervous System Disorders (NSD) - Any Event, mild 32 31
NSD - Any Event, moderate 8 16
NSD - Any Event, severe 1 3
NSD - Dizziness, mild 11 8
NSD - Dizziness, moderate 4 8
NSD - Dizziness, severe 1 0
NSD - Headache, mild 6 8
NSD - Headache, moderate 3 6
NSD - Headache, severe 0 1
NSD - Somnolence, mild 10 8
NSD - Somnolence, moderate 0 0
NSD - Somnolence, severe 0 0
NSD - Hypoesthesia, mild 5 1
NSD - Hypoesthesia, moderate 1 0
NSD - Hypoesthesia, severe 0 0
NSD - Dysgeusia, mild 0 4
NSD - Dysgeusia, moderate 0 1
NSD - Dysgeusia, severe 0 0
NSD - Depressed Level of Consciousness, mild 0 1
NSD - Depressed Level of Consciousness, moderate 0 2
NSD - Depressed Level of Consciousness, severe 0 1
NSD - Tremor, mild 0 4
NSD - Tremor, moderate 0 0
NSD - Tremor, severe 0 0
NSD - Convulsion, mild 0 0
NSD - Convulsion, moderate 0 1
NSD - Convulsion, severe 0 1
NSD - Dizziness postural, mild 0 1
NSD - Dizziness postural, moderate 1 0
NSD - Dizziness postural, severe 0 0
NSD - Dysesthesia, mild 0 0
NSD - Dysesthesia, moderate 1 1
NSD - Dysesthesia, severe 0 0
NSD - Parosmia, mild 2 0
NSD - Parosmia, moderate 0 0
NSD - Parosmia, severe 0 0
NSD - Akathisia, mild 0 0
NSD - Akathisia, moderate 1 0
NSD - Akathisia, severe 0 0
NSD - Anterograde Amnesia, mild 1 0
NSD - Anterograde Amnesia, moderate 0 0
NSD - Anterograde Amnesia, severe 0 0
NSD - Dysarthria, mild 1 0
NSD - Dysarthria, moderate 0 0
NSD - Dysarthria, severe 0 0
NSD - Head discomfort, mild 1 0
NSD - Head discomfort, moderate 0 0
NSD - Head discomfort, severe 0 0
NSD - Hyperesthesia, mild 0 1
NSD - Hyperesthesia, moderate 0 0
NSD - Hyperesthesia, severe 0 0
NSD - Loss of consciousness, mild 0 1
NSD - Loss of consciousness, moderate 0 0
NSD - Loss of consciousness, severe 0 0
NSD - Paraesthesia, mild 0 1
NSD - Paraesthesia, moderate 0 0
NSD - Paraesthesia, severe 0 0
Gastrointestinal Disorders (GID)-Any Event, mild 28 32
GID - Any Event, moderate 15 14
GID - Any Event, severe 1 0
GID - Nausea, mild 12 16
GID - Nausea, moderate 8 10
GID - Nausea, severe 1 0
GID - Diarrhea, mild 6 6
GID - Diarrhea, moderate 3 1
GID - Diarrhea, severe 0 0
GID - Vomiting, mild 4 5
GID - Vomiting, moderate 4 2
GID - Vomiting, severe 0 0
GID - Abdominal Pain upper, mild 0 3
GID - Abdominal Pain upper, moderate 1 2
GID - Abdominal Pain upper, severe 0 0
GID - Stomach Discomfort, mild 2 3
GID - Stomach Discomfort, moderate 1 0
GID - Stomach Discomfort, severe 0 0
GID - Constipation, mild 5 0
GID - Constipation, moderate 0 0
GID - Constipation, severe 0 0
GID - Abdominal Pain, mild 1 3
GID - Abdominal Pain, moderate 0 0
GID - Abdominal Pain, severe 0 0
GID - Stomatitis, mild 1 2
GID - Stomatitis, moderate 0 1
GID - Stomatitis, severe 0 0
GID - Toothache, mild 2 0
GID - Toothache, moderate 1 0
GID - Toothache, severe 0 0
GID - Abdominal Distension, mild 0 2
GID - Abdominal Distension, moderate 0 0
GID - Abdominal Distension, severe 0 0
GID - Gastritis, mild 1 1
GID - Gastritis, moderate 0 0
GID - Gastritis, severe 0 0
GID - Hypoesthesia oral, mild 1 1
GID - Hypoesthesia oral, moderate 0 0
GID - Hypoesthesia oral, severe 0 0
GID - Melaena, mild 1 1
GID - Melaena, moderate 0 0
GID - Melaena, severe 0 0
GID - Abdominal Pain Lower, mild 0 0
GID - Abdominal Pain Lower, moderate 0 1
GID - Abdominal Pain Lower, severe 0 0
GID - Dyspepsia, mild 0 0
GID - Dyspepsia, moderate 1 0
GID - Dyspepsia, severe 0 0
GID - Gingival Swelling, mild 1 0
GID - Gingival Swelling, moderate 0 0
GID - Gingival Swelling, severe 0 0
Infections and Infestations (INF)-Any Event, mild 38 30
INF - Any Event, moderate 3 4
INF - Any Event, severe 0 0
INF - Nasopharyngitis, mild 31 24
INF - Nasopharyngitis, moderate 0 4
INF - Nasopharyngitis, severe 0 0
INF - Gastrointestinal infection, mild 3 3
INF - Gastrointestinal infection, moderate 0 0
INF - Gastrointestinal infection, severe 0 0
INF - Bronchitis acute, mild 0 3
INF - Bronchitis acute, moderate 0 0
INF - Bronchitis acute, severe 0 0
INF - Bronchitis, mild 1 0
INF - Bronchitis, moderate 1 0
INF - Bronchitis, severe 0 0
INF - Gastroenteritis, mild 1 0
INF - Gastroenteritis, moderate 1 0
INF - Gastroenteritis, severe 0 0
INF - Enteritis Infectious, mild 1 0
INF - Enteritis Infectious, moderate 0 0
INF - Enteritis Infectious, severe 0 0
INF - Gastroenteritis viral, mild 0 0
INF - Gastroenteritis viral, moderate 1 0
INF - Gastroenteritis viral, severe 0 0
INF - Otitis Externa, mild 1 0
INF - Otitis Externa, moderate 0 0
INF - Otitis Externa, severe 0 0
INF - Purulence, mild 1 0
INF - Purulence, moderate 0 0
INF - Purulence, severe 0 0
INF - Rhinitis, mild 0 1
INF - Rhinitis, moderate 0 0
INF - Rhinitis, severe 0 0
INF - Vaginal Candidiasis, mild 1 0
INF - Vaginal Candidiasis, moderate 0 0
INF - Vaginal Candidiasis, severe 0 0
Psychiatric Disorders (PsyDO) - Any Event, mild 8 10
PsyDO - Any Event, moderate 13 14
PsyDO - Any Event, severe 7 5
PsyDO - Depression, mild 2 2
PsyDO - Depression, moderate 11 9
PsyDO - Depression, severe 7 3
PsyDO - Insomnia, mild 0 4
PsyDO - Insomnia, moderate 1 1
PsyDO - Insomnia, severe 0 0
PsyDO - Mood altered, mild 3 2
PsyDO - Mood altered, moderate 0 1
PsyDO - Mood altered, severe 0 0
PsyDO - Mania, mild 0 0
PsyDO - Mania, moderate 1 0
PsyDO - Mania, severe 0 1
PsyDO - Anxiety, mild 1 0
PsyDO - Anxiety, moderate 0 0
PsyDO - Anxiety, severe 0 0
PsyDO - Bipolar Disorder, mild 0 0
PsyDO - Bipolar Disorder, moderate 0 0
PsyDO - Bipolar Disorder, severe 0 1
PsyDO - Bruxism, mild 0 1
PsyDO - Bruxism, moderate 0 0
PsyDO - Bruxism, severe 0 0
PsyDO - Delerium, mild 0 1
PsyDO - Delerium, moderate 0 0
PsyDO - Delerium, severe 0 0
PsyDO - Depression suicidal, mild 0 0
PsyDO - Depression suicidal, moderate 0 1
PsyDO - Depression suicidal, severe 0 0
PsyDO - Dysphoria, mild 0 1
PsyDO - Dysphoria, moderate 0 0
PsyDO - Dysphoria, severe 0 0
PsyDO - Early morning awakening, mild 0 0
PsyDO - Early morning awakening, moderate 0 1
PsyDO - Early morning awakening, severe 0 0
PsyDO - Hallucination, mild 0 1
PsyDO - Hallucination, moderate 0 0
PsyDO - Hallucination, severe 0 0
PsyDO - Hypomania, mild 1 0
PsyDO - Hypomania, moderate 0 0
PsyDO - Hypomania, severe 0 0
PsyDO - Intentional self-injury, mild 1 0
PsyDO - Intentional self-injury, moderate 0 0
PsyDO - Intentional self-injury, severe 0 0
PsyDO - Libido decreased, mild 1 0
PsyDO - Libido decreased, moderate 0 0
PsyDO - Libido decreased, severe 0 0
PsyDO - Nightmare, mild 0 0
PsyDO - Nightmare, moderate 0 1
PsyDO - Nightmare, severe 0 0
General Disorders (GD) - Any Event, mild 10 16
GD - Any Event, moderate 5 5
GD - Any Event, severe 0 0
GD - Drug Withdrawal Syndrome, mild 2 6
GD - Drug Withdrawal Syndrome, moderate 2 3
GD - Drug Withdrawal Syndrome, severe 0 0
GD - Thirst, mild 4 9
GD - Thirst, moderate 0 0
GD - Thirst, severe 0 0
GD - Malaise, mild 1 1
GD - Malaise, moderate 2 0
GD - Malaise, severe 0 0
GD - Feeling abnormal, mild 0 1
GD - Feeling abnormal, moderate 0 1
GD - Feeling abnormal, severe 0 0
GD - Irritability, mild 0 0
GD - Irritability, moderate 1 1
GD - Irritability, severe 0 0
GD - Chills, mild 1 0
GD - Chills, moderate 0 0
GD - Chills, severe 0 0
GD - Edema, mild 1 0
GD - Edema, moderate 0 0
GD - Edema, severe 0 0
GD - Edema peripheral, mild 1 0
GD - Edema peripheral, moderate 0 0
GD - Edema peripheral, severe 0 0
GD - Pain, mild 1 0
GD - Pain, moderate 0 0
GD - Pain, severe 0 0
Skin & tissue disorders (SDO) - Any Event, mild 6 8
SDO - Any Event, moderate 1 6
SDO - Any Event, severe 0 1
SDO - Urticaria, mild 0 1
SDO - Urticaria, moderate 0 4
SDO - Urticaria, severe 0 0
SDO - Rash, mild 1 2
SDO - Rash, moderate 0 1
SDO - Rash, severe 0 0
SDO - Eczema, mild 1 1
SDO - Eczema, moderate 0 0
SDO - Eczema, severe 0 0
SDO - Hyperhidrosis, mild 2 0
SDO - Hyperhidrosis, moderate 0 0
SDO - Hyperhidrosis, severe 0 0
SDO - Hypoesthesia facial, mild 0 2
SDO - Hypoesthesia facial, moderate 0 0
SDO - Hypoesthesia facial, severe 0 0
SDO - Pruritus generalised, mild 0 1
SDO - Pruritus generalised, moderate 0 1
SDO - Pruritus generalised, severe 0 0
SDO - Alopecia, mild 0 0
SDO - Alopecia, moderate 0 1
SDO - Alopecia, severe 0 0
SDO - Alopecia areata, mild 0 1
SDO - Alopecia areata, moderate 0 0
SDO - Alopecia areata, severe 0 0
SDO - Dermatitis Contact, mild 0 0
SDO - Dermatitis Contact, moderate 1 0
SDO - Dermatitis Contact, severe 0 0
SDO - Erythema, mild 1 0
SDO - Erythema, moderate 0 0
SDO - Erythema, severe 0 0
SDO - Hemorrhage subcutaneous, mild 0 0
SDO - Hemorrhage subcutaneous, moderate 0 0
SDO - Hemorrhage subcutaneous, severe 0 1
SDO - Hyperkeratosis, mild 0 1
SDO - Hyperkeratosis, moderate 0 0
SDO - Hyperkeratosis, severe 0 0
SDO - Pigmentation disorder, mild 1 0
SDO - Pigmentation disorder, moderate 0 0
SDO - Pigmentation disorder, severe 0 0
SDO - Sweat Gland Disorder, mild 0 1
SDO - Sweat Gland Disorder, moderate 0 0
SDO - Sweat Gland Disorder, severe 0 0
Investigations (INV) - Any Event, mild 5 10
INV - Any Event, moderate 1 2
INV - Any Event, severe 0 0
INV - Alanine Aminotransferase increased, mild 3 4
INV - Alanine Aminotransferase increased, moderate 0 0
INV - Alanine Aminotransferase increased, severe 0 0
INV - Weight decreased, mild 0 3
INV - Weight decreased, moderate 0 0
INV - Weight decreased, severe 0 0
INV - Aspartate Aminotransferase increased, mild 0 2
INV-Aspartate Aminotransferase increased, moderate 0 0
INV - Aspartate Aminotransferase increased, severe 0 0
INV - Blood Bilirubin increased, mild 1 1
INV - Blood Bilirubin increased, moderate 0 0
INV - Blood Bilirubin increased, severe 0 0
INV - Glucose urine present, mild 0 1
INV - Glucose urine present, moderate 0 1
INV - Glucose urine present, severe 0 0
INV - Protein urine present, mild 0 2
INV - Protein urine present, moderate 0 0
INV - Protein urine present, severe 0 0
INV - White Blood Cell Count decreased, mild 0 1
INV - White Blood Cell Count decreased, moderate 0 1
INV - White Blood Cell Count decreased, severe 0 0
INV - Blood pressure decreased, mild 0 0
INV - Blood pressure decreased, moderate 1 0
INV - Blood pressure decreased, severe 0 0
INV - Electrocardiogram T wave inversion, mild 1 0
INV - Electrocardiogram T wave inversion, moderate 0 0
INV - Electrocardiogram T wave inversion, severe 0 0
INV - Hematocrit decreased, mild 0 1
INV - Hematocrit decreased, moderate 0 0
INV - Hematocrit decreased, severe 0 0
INV - Hemoglobin decreased, mild 0 1
INV - Hemoglobin decreased, moderate 0 0
INV - Hemoglobin decreased, severe 0 0
INV - Red Blood Cell Count decreased, mild 0 1
INV - Red Blood Cell Count decreased, moderate 0 0
INV - Red Blood Cell Count decreased, severe 0 0
Musculoskeletal Disorders (MD) - Any Event, mild 9 6
MD - Any Event, moderate 0 2
MD - Any Event, severe 0 0
MD - Back Pain, mild 1 1
MD - Back Pain, moderate 0 2
MD - Back Pain, severe 0 0
MD - Musculoskeletal stiffness, mild 3 1
MD - Musculoskeletal stiffness, moderate 0 0
MD - Musculoskeletal stiffness, severe 0 0
MD - Myalgia, mild 2 1
MD - Myalgia, moderate 0 0
MD - Myalgia, severe 0 0
MD - Neck Pain, mild 0 2
MD - Neck Pain, moderate 0 0
MD - Neck Pain, severe 0 0
MD - Pain in extremity, mild 2 0
MD - Pain in extremity, moderate 0 0
MD - Pain in extremity, severe 0 0
MD - Arthralgia, mild 0 1
MD - Arthralgia, moderate 0 0
MD - Arthralgia, severe 0 0
MD - Fasciitis, mild 1 0
MD - Fasciitis, moderate 0 0
MD - Fasciitis, severe 0 0
Respiratory Disorders (RTM) - Any Event, mild 4 6
RTM -Any Event, moderate 0 3
RTM -Any Event, severe 0 0
RTM - Upper respiratory Tract inflammation, mild 3 3
RTM-Upp. respiratory Tract inflammation, moderate 0 1
RTM-Upp. respiratory Tract inflammation, severe 0 0
RTM - Asthma, mild 0 2
RTM - Asthma, moderate 0 1
RTM - Asthma, severe 0 0
RTM - Cough, mild 0 1
RTM - Cough, moderate 0 1
RTM - Cough, severe 0 0
RTM - Pharyngolaryngeal Pain, mild 1 0
RTM - Pharyngolaryngeal Pain, moderate 0 0
RTM - Pharyngolaryngeal Pain, severe 0 0
Injury and complications (IPPC) - Any Event, mild 2 2
IPPC - Any Event, moderate 1 3
IPPC - Any Event, severe 0 0
IPPC - Contusion, mild 0 2
IPPC - Contusion, moderate 0 0
IPPC - Contusion, severe 0 0
IPPC - Intentional Overdose, mild 1 0
IPPC - Intentional Overdose, moderate 0 1
IPPC - Intentional Overdose, severe 0 0
IPPC - Head Injury, mild 0 0
IPPC - Head Injury, moderate 0 1
IPPC - Head Injury, severe 0 0
IPPC - Joint sprain, mild 0 1
IPPC - Joint sprain, moderate 0 0
IPPC - Joint sprain, severe 0 0
IPPC - Rib fracture, mild 0 0
IPPC - Rib fracture, moderate 1 0
IPPC - Rib fracture, severe 0 0
IPPC - Thermal Burn, mild 0 0
IPPC - Thermal Burn, moderate 0 1
IPPC - Thermal Burn, severe 0 0
IPPC - Wound, mild 1 0
IPPC - Wound, moderate 0 0
IPPC - Wound, severe 0 0
Ear Disorders (ED) - Any Event, mild 3 2
ED - Any Event, moderate 0 0
ED - Any Event, severe 0 0
ED - Tinnitus, mild 2 2
ED - Tinnitus, moderate 0 0
ED - Tinnitus, severe 0 0
ED - Ear Discomfort, mild 1 0
ED - Ear Discomfort, moderate 0 0
ED - Ear Discomfort, severe 0 0
Eye Disorders (EyeDO) - Any Event, mild 0 1
EyeDO - Any Event, moderate 0 3
EyeDO - Any Event, severe 0 0
EyeDO - Chalazion, mild 0 0
EyeDO - Chalazion, moderate 0 2
EyeDO - Chalazion, severe 0 0
EyeDO - Abnormal sensations in eye, mild 0 0
EyeDO - Abnormal sensations in eye, moderate 0 1
EyeDO - Abnormal sensations in eye, severe 0 0
EyeDO - Conjunctival haemorrhage, mild 0 1
EyeDO - Conjunctival haemorrhage, moderate 0 0
EyeDO - Conjunctival haemorrhage, severe 0 0
Metabolism Disorders (MetDO) - Any Event, mild 2 1
MetDO - Any Event, moderate 1 0
MetDO - Any Event, severe 0 0
MetDO - Anorexia, mild 0 1
MetDO - Anorexia, moderate 1 0
MetDO - Anorexia, severe 0 0
MetDO - Dehydration, mild 2 0
MetDO - Dehydration, moderate 0 0
MetDO - Dehydration, severe 0 0
MetDO - Hyperlipidemia, mild 1 0
MetDO - Hyperlipidemia, moderate 0 0
MetDO - Hyperlipidemia, severe 0 0
MetDO - Hypovitaminosis, mild 1 0
MetDO - Hypovitaminosis, moderate 0 0
MetDO - Hypovitaminosis, severe 0 0
Vascular Disorders (VD) - Any Event, mild 2 2
VD - Any Event, moderate 0 0
VD - Any Event, severe 0 0
VD - Hot Flush, mild 1 2
VD - Hot Flush, moderate 0 0
VD - Hot Flush, severe 0 0
VD - Hypertension, mild 1 0
VD - Hypertension, moderate 0 0
VD - Hypertension, severe 0 0
Blood & Lymph Disorders (BLD) - Any Event, mild 0 2
BLD - Any Event, moderate 0 1
BLD - Any Event, severe 0 0
BLD - Anemia, mild 0 1
BLD - Anemia, moderate 0 1
BLD - Anemia, severe 0 0
BLD - Lymphadenopathy, mild 0 1
BLD - Lymphadenopathy, moderate 0 0
BLD - Lymphadenopathy, severe 0 0
Hepatobiliary disorders (HD) - Any Event, mild 1 1
HD - Any Event, moderate 0 1
HD - Any Event, severe 0 0
HD - Hepatic Function abnormal, mild 1 1
HD - Hepatic Function abnormal, moderate 0 1
HD - Hepatic Function abnormal, severe 0 0
Reproductive Disorders (RBD) - Any Event, mild 0 1
RBD - Any Event, moderate 0 1
RBD - Any Event, severe 0 1
RBD - Galactorrhea, mild 0 0
RBD - Galactorrhea, moderate 0 1
RBD - Galactorrhea, severe 0 0
RBD - Menometrorrhagia, mild 0 1
RBD - Menometrorrhagia, moderate 0 0
RBD - Menometrorrhagia, severe 0 0
RBD - Premenstrual Syndrome, mild 0 0
RBD - Premenstrual Syndrome, moderate 0 0
RBD - Premenstrual Syndrome, severe 0 1
Cardiac Disorders (CD) - Any Event, mild 1 1
CD - Any Event, moderate 0 0
CD - Any Event, severe 0 0
CD - Palpitations, mild 1 1
CD - Palpitations, moderate 0 0
CD - Palpitations, severe 0 0
Renal & Urinary Disorders (RUD) - Any Event, mild 0 2
RUD - Any Event, moderate 0 0
RUD - Any Event, severe 0 0
RUD - Dysuria, mild 0 1
RUD - Dysuria, moderate 0 0
RUD - Dysuria, severe 0 0
RUD - Pollakiuria, mild 0 1
RUD - Pollakiuria, moderate 0 0
RUD - Pollakiuria, severe 0 0
Endocrine Disorders (ENDO) - Any Event, mild 0 1
ENDO - Any Event, moderate 0 0
ENDO - Any Event, severe 0 0
ENDO - Hyperprolactinaemia, mild 0 1
ENDO - Hyperprolactinaemia, moderate 0 0
ENDO - Hyperprolactinaemia, severe 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Bupropion SR
Hide Arm/Group Description Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period. Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
All-Cause Mortality
Placebo Bupropion SR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Bupropion SR
Affected / at Risk (%) Affected / at Risk (%)
Total   0   5 
Nervous system disorders     
Depressed level of Consciousness  1  0/159 (0.00%)  2/166 (1.20%) 
Convulsion  1  0/159 (0.00%)  1/166 (0.60%) 
Psychiatric disorders     
Bipolar Disorder  1  0/159 (0.00%)  1/166 (0.60%) 
Mania  1  0/159 (0.00%)  1/166 (0.60%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/159 (0.00%)  1/166 (0.60%) 
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%
Placebo Bupropion SR
Affected / at Risk (%) Affected / at Risk (%)
Total   124/159 (77.99%)   125/166 (75.30%) 
Gastrointestinal disorders     
Nausea  1  21/159 (13.21%)  26/166 (15.66%) 
Diarrhea  1  9/159 (5.66%)  7/166 (4.22%) 
Vomiting  1  8/159 (5.03%)  7/166 (4.22%) 
General disorders     
Drug Withdrawal syndrome  1  4/159 (2.52%)  9/166 (5.42%) 
Thirst  1  4/159 (2.52%)  9/166 (5.42%) 
Infections and infestations     
Nasopharyngitis  1  31/159 (19.50%)  28/166 (16.87%) 
Nervous system disorders     
Dizziness  1  16/159 (10.06%)  16/166 (9.64%) 
Headache  1  9/159 (5.66%)  15/166 (9.04%) 
Psychiatric disorders     
Depression  1  20/159 (12.58%)  14/166 (8.43%) 
Somnolence  1  10/159 (6.29%)  8/166 (4.82%) 
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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00296517     History of Changes
Other Study ID Numbers: AK1102365
First Submitted: February 23, 2006
First Posted: February 27, 2006
Results First Submitted: March 19, 2009
Results First Posted: July 16, 2009
Last Update Posted: September 25, 2018