Major Depressive Disorder (MDD)
Conditions
Keywords
WELLBUTRIN, elderly, depression, Pharmacokinetics
Brief summary
This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on safety, efficacy and pharmacokinetics profile in elderly patients with depression.
Interventions
DRUG323U66 SR
Sponsors
GlaxoSmithKline
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Target disease: Patients diagnosed as having the following primary disease and current major depressive episode for at least 8 weeks on the basis of DSM-IV-TR criteria. * Major Depressive Disorder, Single Episode (296.2x) (excluding those with psychotic features) * Major Depressive Disorder, Recurrent (296.3x). (excluding those with psychotic features) * HAM-D (17 items) total score \>/=18. * Age: \>/=65 years old (at the time of informed consent) * Gender: Male or female. * Inpatient or outpatient status: Either * Informed consent: The subject himself/herself must give written informed consent.
Exclusion criteria
* Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure) * Patients who currently have or have a past history of the following disorders: * Anorexia nervosa (DSM-IV-TR 307.1) * Bulimia nervosa (DSM-IV-TR 307.51) * Patients with a history of manic episode * Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder * Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder) * Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and standardized cognitive behaviour therapy within 12 weeks prior to the start of the treatment phase * Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the treatment phase * Patients who have received electroconvulsive therapy within 24 weeks prior to the start of the treatment phase * Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the treatment phase * Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase * Patients who have attempted suicide within 24 weeks prior to the start of the treatment phase, or patients for whom the score of the suicide-related item of HAM-D is \>/=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator). * Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator). * Patients with a history of hypersensitivity to 323U66 * Patients with serious cerebral disease * Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) assesses the subject is predisposed to ischemia or arrhythmia * Patients with serious physical symptoms (i.e. cardiac/hepatic/renal disorder, hematopoietic disorder). The index of seriousness is Grade 3 of Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc. (PAB/PSD No.80 in 1992). * Patients who have a history or complicated carcinoma or malignant tumour. * Patients whose major depressive disorder is due to direct physiological effects of a general medical condition (for example, hypothyroidism, Parkinson's disease, chronic pain) * Patients with systolic blood pressure of \>/=160 mmHg or diastolic blood pressure of \>/=100 mmHg at the start of the Treatment Period * Patients diagnosed with dementia * Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8 | Baseline and Week 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8 | Baseline and Week 8 | 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). |
| Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4 | Week 4 | 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. |
| Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8 | Week 8 | 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. |
| Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4 | Week 4 | 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. |
| Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8 | Week 8 | 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. |
| Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4 | Baseline and Week 4 | 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). |
| Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 | Baseline and Week 8 | 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). |
| Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 | Baseline and Week 4 | 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). |
| Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8 | Baseline and Week 8 | 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). |
| Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8 | Week 4 and Week 8 | 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). |
| Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8 | Week 4 and Week 8 | 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. |
| Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8 | Baseline, Weeks 1, 2, 3, 4, 8 | 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). |
| Adverse Events (>=5% Incidence) | Baseline through Week 8 | — |
| Serious Adverse Events | Baseline through Week 8 | — |
| Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4 | Baseline and Week 4 | 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). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion SR | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Bupropion SR |
|---|---|
| Age, Continuous | 73.5 Years STANDARD_DEVIATION 5.08 |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 35 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / — |
| serious Total, serious adverse events | 1 / — |
Outcome results
Primary
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion SR | 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
Adverse Events (>=5% Incidence)
Time frame: Baseline through Week 8
Population: Safety population - all subjects who took at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bupropion SR | Adverse Events (>=5% Incidence) | Depression | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Excoriation | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Glossitis | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Paraesthesia Oral | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Vomiting | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Irritability | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Oedema Peripheral | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Somnolence | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Blood Pressure Increased | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Pruritus | 2 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Nausea | 6 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Constipation | 5 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Dizziness | 5 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Nasopharyngitis | 4 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Pyrexia | 3 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Thirst | 3 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Weight Decreased | 3 Participants |
| Bupropion SR | Adverse Events (>=5% Incidence) | Back Pain | 2 Participants |
Secondary
Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 1.5 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 0.9 |
| Bupropion SR | 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 0.8 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
Secondary
Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion SR | Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 | -41.7 Percentage of Change | Standard Deviation 25.4 |
Secondary
Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion SR | 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
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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
Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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 60.3 |
| Bupropion SR | 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 |
| Bupropion SR | 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 |
| Bupropion SR | 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
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
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
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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Bupropion SR | Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4 | 17.6 Percentage of Remitters | 30.54 |
Secondary
Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion SR | Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8 | 50.0 Percentage of Remitters |
Secondary
Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bupropion SR | 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 |
| Bupropion SR | 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
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4
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
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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Bupropion SR | Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4 | 29.4 Percentage of Responders | 25.4 |
Secondary
Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion SR | Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8 | 64.3 Percentage of Responders |
Secondary
Serious Adverse Events
Time frame: Baseline through Week 8
Population: Safety population - all subjects who took at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion SR | Serious Adverse Events | 1 Participants |