Trial Outcomes & Findings for Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan (NCT NCT00330616)

NCT ID: NCT00330616

Last Updated: 2015-05-04

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Baseline and Week 8
• Results posted on: 2015-05-04

Participant Flow

Participant milestones

Measure	Bupropion SR 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.
Overall Study STARTED	35
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	Bupropion SR 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.
Overall Study Adverse Event	13
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	4
Overall Study Other	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bupropion SR n=35 Participants
Age, Continuous	73.5 Years STANDARD_DEVIATION 5.08 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=32 Participants
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8	-8.4 Scores on a scale Standard Deviation 10.34

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=17 Participants
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4	-41.7 Percentage of Change Standard Deviation 25.40

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=14 Participants
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8	-60.7 Percentage of Change Standard Deviation 30.54

SECONDARY outcome

Timeframe: Week 4

Population: 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.

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.

Outcome measures

Measure	Bupropion SR n=17 Participants
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4	29.4 Percentage of Responders 25.40

SECONDARY outcome

Timeframe: Week 8

Population: 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.

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.

Outcome measures

Measure	Bupropion SR n=14 Participants
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8	64.3 Percentage of Responders

SECONDARY outcome

Timeframe: Week 4

Population: 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.

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.

Outcome measures

Measure	Bupropion SR n=17 Participants
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4	17.6 Percentage of Remitters 30.54

SECONDARY outcome

Timeframe: Week 8

Population: 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.

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.

Outcome measures

Measure	Bupropion SR n=14 Participants
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8	50.0 Percentage of Remitters

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=17 Participants
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Retardation	-1.2 Scores on a scale Standard Deviation 0.53
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Anxiety Psychic	-0.9 Scores on a scale Standard Deviation 1.14
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Anxiety Somatic	-0.8 Scores on a scale Standard Deviation 0.81
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Somatic Symptoms GI	-0.3 Scores on a scale Standard Deviation 0.77
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Somatic Symptoms General	-0.2 Scores on a scale Standard Deviation 0.90
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Genital Symptoms	-0.5 Scores on a scale Standard Deviation 0.80
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Hypochondriasis	-0.5 Scores on a scale Standard Deviation 0.94
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Lose Weight History	-0.8 Scores on a scale Standard Deviation 0.88
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Insight	-0.4 Scores on a scale Standard Deviation 0.62
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Depressed Mood	-1.4 Scores on a scale Standard Deviation 1.23
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Feelings of Guilt	-0.7 Scores on a scale Standard Deviation 0.99
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Suicide	-0.9 Scores on a scale Standard Deviation 1.03
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Insomnia Early	-0.5 Scores on a scale Standard Deviation 0.87
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Insomnia Middle	-0.5 Scores on a scale Standard Deviation 0.72
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Insomnia Late	-0.6 Scores on a scale Standard Deviation 0.94
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 Work/Activities	-0.9 Scores on a scale Standard Deviation 1.17

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=14 Participants
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Depressed Mood	-1.9 Scores on a scale Standard Deviation 1.46
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Feelings of Guilt	-1.0 Scores on a scale Standard Deviation 1.11
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Suicide	-1.1 Scores on a scale Standard Deviation 0.92
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insomnia Early	-0.9 Scores on a scale Standard Deviation 0.86
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insomnia Middle	-0.6 Scores on a scale Standard Deviation 0.74
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insomnia Late	-0.9 Scores on a scale Standard Deviation 0.86
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Work/Activities	-1.4 Scores on a scale Standard Deviation 1.50
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Retardation	-1.4 Scores on a scale Standard Deviation 0.63
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Agitation	-0.5 Scores on a scale Standard Deviation 0.94
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Anxiety Psychic	-1.5 Scores on a scale Standard Deviation 1.34
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Anxiety Somatic	-1.1 Scores on a scale Standard Deviation 0.86
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Somatic Symptoms GI	-0.6 Scores on a scale Standard Deviation 0.84
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Somatic Symptoms General	-0.8 Scores on a scale Standard Deviation 0.89
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Genital Symptoms	-0.6 Scores on a scale Standard Deviation 0.93
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Hypochondriasis	-0.9 Scores on a scale Standard Deviation 1.07
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Lose Weight History	-1.1 Scores on a scale Standard Deviation 1.21
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insight	-0.4 Scores on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=17 Participants
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Depressed Mood	-47.1 Percentage of Change Standard Deviation 39.74
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Feelings of Guilt	-76.7 Percentage of Change Standard Deviation 34.43
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Suicide	-80.0 Percentage of Change Standard Deviation 36.84
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Insomnia Early	-41.7 Percentage of Change Standard Deviation 59.67
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Insomnia Middle	-40.6 Percentage of Change Standard Deviation 58.36
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Insomnia Late	-42.9 Percentage of Change Standard Deviation 47.46
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Work/Activities	-27.9 Percentage of Change Standard Deviation 31.86
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Retardation	-73.5 Percentage of Change Standard Deviation 31.21
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Agitation	-45.8 Percentage of Change Standard Deviation 68.28
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Anxiety Psychic	-34.8 Percentage of Change Standard Deviation 43.72
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Anxiety Somatic	-54.2 Percentage of Change Standard Deviation 39.67
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Somatic Symptoms GI	-21.4 Percentage of Change Standard Deviation 57.89
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Somatic Symptoms General	-17.9 Percentage of Change Standard Deviation 50.41
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Genital Symptoms	-40.9 Percentage of Change Standard Deviation 62.52
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Hypochondriasis	-38.1 Percentage of Change Standard Deviation 44.54
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Lose Weight History	-57.7 Percentage of Change Standard Deviation 44.94
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 Insight	-60.0 Percentage of Change Standard Deviation 51.64

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=14 Participants
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Depressed Mood	-60.7 Percentage of Change Standard Deviation 40.62
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Feelings of Guilt	-100.0 Percentage of Change Standard Deviation 0
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Suicide	-83.3 Percentage of Change Standard Deviation 32.57
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insomnia Early	-70.0 Percentage of Change Standard Deviation 42.16
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insomnia Middle	-50.0 Percentage of Change Standard Deviation 61.24
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insomnia Late	-68.2 Percentage of Change Standard Deviation 46.22
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Work/Activities	-42.3 Percentage of Change Standard Deviation 46.74
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Retardation	-78.6 Percentage of Change Standard Deviation 32.31
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Agitation	-52.8 Percentage of Change Standard Deviation 77.76
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Anxiety Psychic	-55.4 Percentage of Change Standard Deviation 48.88
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Anxiety Somatic	-60.7 Percentage of Change Standard Deviation 55.32
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Somatic Symptoms GI	-45.8 Percentage of Change Standard Deviation 62.01
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Somatic Symptoms General	-50.0 Percentage of Change Standard Deviation 60.30
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Genital Symptoms	-45.5 Percentage of Change Standard Deviation 65.02
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Hypochondriasis	-50.0 Percentage of Change Standard Deviation 43.23
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Lose Weight History	-81.8 Percentage of Change Standard Deviation 33.71
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 Insight	-50.0 Percentage of Change Standard Deviation 70.71

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=32 Participants
Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8 Week 4	17.3 Scores on a scale Standard Deviation 6.94
Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8 Week 8	15.7 Scores on a scale Standard Deviation 8.41

SECONDARY outcome

Timeframe: Week 4 and Week 8

Population: 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.

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.

Outcome measures

Measure	Bupropion SR n=33 Participants
Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8 Week 4	24.2 Percentage of Responders
Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8 Week 8	42.4 Percentage of Responders

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 8

Population: 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.

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).

Outcome measures

Measure	Bupropion SR n=34 Participants
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8 Week 1	-0.2 Scores on a scale Standard Deviation 0.63
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8 Week 2	-0.4 Scores on a scale Standard Deviation 0.73
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8 Week 3	-0.4 Scores on a scale Standard Deviation 0.86
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8 Week 4	-0.6 Scores on a scale Standard Deviation 0.99
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8 Week 8	-0.9 Scores on a scale Standard Deviation 1.22

SECONDARY outcome

Timeframe: Baseline through Week 8

Population: Safety population - all subjects who took at least one dose of study medication.

Outcome measures

Measure	Bupropion SR n=35 Participants
Adverse Events (>=5% Incidence) Nausea	6 Participants
Adverse Events (>=5% Incidence) Constipation	5 Participants
Adverse Events (>=5% Incidence) Dizziness	5 Participants
Adverse Events (>=5% Incidence) Nasopharyngitis	4 Participants
Adverse Events (>=5% Incidence) Pyrexia	3 Participants
Adverse Events (>=5% Incidence) Thirst	3 Participants
Adverse Events (>=5% Incidence) Weight Decreased	3 Participants
Adverse Events (>=5% Incidence) Glossitis	2 Participants
Adverse Events (>=5% Incidence) Paraesthesia Oral	2 Participants
Adverse Events (>=5% Incidence) Vomiting	2 Participants
Adverse Events (>=5% Incidence) Irritability	2 Participants
Adverse Events (>=5% Incidence) Oedema Peripheral	2 Participants
Adverse Events (>=5% Incidence) Somnolence	2 Participants
Adverse Events (>=5% Incidence) Blood Pressure Increased	2 Participants
Adverse Events (>=5% Incidence) Pruritus	2 Participants
Adverse Events (>=5% Incidence) Depression	2 Participants
Adverse Events (>=5% Incidence) Excoriation	2 Participants
Adverse Events (>=5% Incidence) Back Pain	2 Participants

SECONDARY outcome

Timeframe: Baseline through Week 8

Population: Safety population - all subjects who took at least one dose of study medication.

Outcome measures

Measure	Bupropion SR n=35 Participants
Serious Adverse Events	1 Participants

Adverse Events

Bupropion SR

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bupropion SR 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.
Psychiatric disorders Suicide attempt	2.9% 1/35 • Number of events 1

Other adverse events

Measure	Bupropion SR 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.
Gastrointestinal disorders Nausea	17.1% 6/35
Gastrointestinal disorders Constipation	14.3% 5/35
Nervous system disorders Dizziness	14.3% 5/35
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	11.4% 4/35
General disorders Pyrexia	8.6% 3/35
General disorders Thirst	8.6% 3/35
Metabolism and nutrition disorders Weight decrease	8.6% 3/35
Gastrointestinal disorders Glossitis	5.7% 2/35
Nervous system disorders Paraesthesia oral	5.7% 2/35
Gastrointestinal disorders Vomiting	5.7% 2/35
Psychiatric disorders Irritability	5.7% 2/35
Blood and lymphatic system disorders Edema Peripheral	5.7% 2/35
Psychiatric disorders Somnolence	5.7% 2/35
Cardiac disorders Blood Pressure increased	5.7% 2/35
General disorders Pruritus	5.7% 2/35
Psychiatric disorders Depression	5.7% 2/35
Skin and subcutaneous tissue disorders Excoriation	5.7% 2/35
General disorders Back Pain	5.7% 2/35

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER