Depressive Disorder, Major
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.
Interventions
DRUGDuloxetine
DRUGplacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years old. * Patient must be diagnosed with depression and have had previous episodes of depression. * Patient must sign informed consent.
Exclusion criteria
* Female and pregnant or breastfeeding. * History of bipolar disorder, schizophrenia, or other psychotic disorders. * Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization. * Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study. * Have taken an antidepressant called fluoxetine within 30 days of the start of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Depressive Recurrence After Time (t) in Days | Every Visit from Week 34 up to Week 86 (Maintenance Phase) | Recurrence: Clinical Global Impression-Severity (CGI-S) score \>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | Every Visit from Week 34 up to Week 86 (Maintenance Phase) | Worsening occurs if patient had a \>=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score \>=3 at any time during the double-blind maintenance therapy phase. |
| Loss of Response at Any Time | Every Visit from Week 35 up to Week 86 (Maintenance Phase) | Loss of response was defined as a HAMD-17 total score \>9 and a CGI-Severity score \>2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not. |
| Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). |
| Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). |
| Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
| Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. |
| Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases | Week 10 (Acute) and Week 34 (Continuation) | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase | Week 86 (Maintenance Phase) | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4). |
| Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4). |
| Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain). |
| Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain). |
| Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity. |
| Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity. |
| Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10. |
| Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10. |
| Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning. |
| Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning. |
| Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Week 0 through Week10 (Acute) through Week 34 (Continuation) | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. |
| Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Week 34 through Week 86 (Maintenance Phase) | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. |
| Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. |
| Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. |
| Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. |
| Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms. |
| Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. |
| Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. |
| Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. |
| Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30. |
| Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | — |
| Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | — |
| Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | — |
| Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | — |
| Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | — |
| Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase | Week 0 and Week 10 | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Recurrence Count | Every Visit from Week 35 up to Week 86 (Maintenance Phase) | Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase. |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | — |
| Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Every Visit from Week 0 up to Week 10 (Acute) | — |
| Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Every Visit from Week 10 up to Week 34 (Continuation) | — |
| Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | — |
Countries
France, Germany, Italy, Russia, Sweden, United States
Participant flow
Pre-assignment details
The Acute - Open Label (Week 0-10) participants were reported in the Baseline Characteristics section of this results record.
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine duloxetine 60-120 mg QD | 514 |
| Total | 514 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Acute - Open Label: Week 0-10 | Adverse Event | 33 | 0 |
| Acute - Open Label: Week 0-10 | Death | 1 | 0 |
| Acute - Open Label: Week 0-10 | Lack of Efficacy | 17 | 0 |
| Acute - Open Label: Week 0-10 | Lost to Follow-up | 4 | 0 |
| Acute - Open Label: Week 0-10 | Physician Decision | 0 | 0 |
| Acute - Open Label: Week 0-10 | Protocol Response Criteria Not Met | 14 | 0 |
| Acute - Open Label: Week 0-10 | Protocol Violation | 8 | 0 |
| Acute - Open Label: Week 0-10 | Recurrence Criteria Met | 0 | 0 |
| Acute - Open Label: Week 0-10 | Unspecified - no reason reported | 0 | 0 |
| Acute - Open Label: Week 0-10 | Withdrawal by Subject | 24 | 0 |
| Continuation - Open Label:Week 10-34 | Adverse Event | 25 | 0 |
| Continuation - Open Label:Week 10-34 | Death | 0 | 0 |
| Continuation - Open Label:Week 10-34 | Lack of Efficacy | 15 | 0 |
| Continuation - Open Label:Week 10-34 | Lost to Follow-up | 9 | 0 |
| Continuation - Open Label:Week 10-34 | Physician Decision | 3 | 0 |
| Continuation - Open Label:Week 10-34 | Protocol Response Criteria Not Met | 16 | 0 |
| Continuation - Open Label:Week 10-34 | Protocol Violation | 5 | 0 |
| Continuation - Open Label:Week 10-34 | Recurrence Criteria Met | 2 | 0 |
| Continuation - Open Label:Week 10-34 | Unspecified - no reason reported | 0 | 0 |
| Continuation - Open Label:Week 10-34 | Withdrawal by Subject | 50 | 0 |
| Maintenance - Double-Blind:Week 34-86 | Adverse Event | 6 | 3 |
| Maintenance - Double-Blind:Week 34-86 | Death | 0 | 0 |
| Maintenance - Double-Blind:Week 34-86 | Lack of Efficacy | 0 | 0 |
| Maintenance - Double-Blind:Week 34-86 | Lost to Follow-up | 4 | 0 |
| Maintenance - Double-Blind:Week 34-86 | Physician Decision | 4 | 1 |
| Maintenance - Double-Blind:Week 34-86 | Protocol Response Criteria Not Met | 0 | 0 |
| Maintenance - Double-Blind:Week 34-86 | Protocol Violation | 5 | 4 |
| Maintenance - Double-Blind:Week 34-86 | Recurrence Criteria Met | 14 | 43 |
| Maintenance - Double-Blind:Week 34-86 | Unspecified - no reason reported | 0 | 0 |
| Maintenance - Double-Blind:Week 34-86 | Withdrawal by Subject | 17 | 18 |
Baseline characteristics
| Characteristic | Duloxetine |
|---|---|
| 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score | 23.07 units on a scale STANDARD_DEVIATION 3.57 |
| Age at First Episode | 33.16 years STANDARD_DEVIATION 13.38 |
| Age Continuous | 47.6 years STANDARD_DEVIATION 13.3 |
| Clinical Global Impressions - Severity (CGI-S) Total Score | 4.49 units on a scale STANDARD_DEVIATION 0.6 |
| Duration of Current Episode | 4.02 months STANDARD_DEVIATION 4.65 |
| Duration of Last Episode | 6.14 months STANDARD_DEVIATION 5.29 |
| Height | 167.6 centimeters STANDARD_DEVIATION 9.23 |
| Number of Previous Episodes | 4.22 previous episodes STANDARD_DEVIATION 3.48 |
| Race/Ethnicity African | 3 participants |
| Race/Ethnicity Caucasian | 504 participants |
| Race/Ethnicity East Asian | 1 participants |
| Race/Ethnicity Hispanic | 5 participants |
| Race/Ethnicity South Asian | 1 participants |
| Region of Enrollment France | 65 participants |
| Region of Enrollment Germany | 161 participants |
| Region of Enrollment Italy | 73 participants |
| Region of Enrollment Russian Federation | 99 participants |
| Region of Enrollment Sweden | 55 participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 359 Participants |
| Sex: Female, Male Male | 155 Participants |
| Time Interval Between Episodes | 8.38 months STANDARD_DEVIATION 6.78 |
| Weight | 74.7 kilograms STANDARD_DEVIATION 16.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 105 / — | 51 / — | 36 / — | 26 / — |
| serious Total, serious adverse events | 5 / — | 5 / — | 3 / — | 4 / — |
Outcome results
Primary
Percentage of Participants With Depressive Recurrence After Time (t) in Days
Recurrence: Clinical Global Impression-Severity (CGI-S) score \>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.
Time frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Population: All randomized patients. Intent to Treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=7 days (N=145, N=139) | 0.68 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=14 days (N=143, N=138) | 1.37 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=21 days (N=141, N=137) | 1.37 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=28 days (N=140, N=135) | 2.07 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=56 days (N=136, N=120) | 4.19 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=84 days (N=131, N=106) | 6.33 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=112 days (N=122, N=96) | 8.58 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=140 days (N=119, N=89) | 9.34 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=168 days (N=115, N=86) | 10.89 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=196 days (N=111, N=86) | 11.69 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=224 days (N=108, N=85) | 12.50 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=252 days (N=105, N=82) | 13.32 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=280 days (N=99, N=77) | 13.32 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=308 days (N=96, N=75) | 13.32 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=336 days (N=95, N=74) | 14.23 percentage of participants |
| Duloxetine | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=364 days (N=93, N=73) | 16.03 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=364 days (N=93, N=73) | 35.74 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=7 days (N=145, N=139) | 2.11 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=168 days (N=115, N=86) | 28.98 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=14 days (N=143, N=138) | 2.11 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=280 days (N=99, N=77) | 34.00 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=21 days (N=141, N=137) | 2.82 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=196 days (N=111, N=86) | 28.98 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=28 days (N=140, N=135) | 3.54 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=336 days (N=95, N=74) | 34.86 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=56 days (N=136, N=120) | 12.97 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=224 days (N=108, N=85) | 29.80 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=84 days (N=131, N=106) | 21.15 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=308 days (N=96, N=75) | 34.86 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=112 days (N=122, N=96) | 25.79 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=252 days (N=105, N=82) | 32.28 percentage of participants |
| Placebo | Percentage of Participants With Depressive Recurrence After Time (t) in Days | t=140 days (N=119, N=89) | 28.98 percentage of participants |
Comparison: A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.p-value: <0.001Log Rank
Secondary
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | Baseline | 23.07 units on a scale | Standard Deviation 3.55 |
| Duloxetine | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | Change from Baseline to Endpoint | -14.37 units on a scale | Standard Deviation 6.03 |
| Placebo | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | Baseline | 6.64 units on a scale | Standard Deviation 2.06 |
| Placebo | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | Change from Baseline to Endpoint | -0.61 units on a scale | Standard Deviation 5.09 |
p-value: <0.001t-test, 2 sided
p-value: 0.016t-test, 2 sided
Secondary
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase | 1.40 units on a scale | Standard Error 0.53 |
| Placebo | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase | 4.36 units on a scale | Standard Error 0.57 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Bodily Pain Baseline (N=460,N=377) | 6.83 units on a scale | Standard Deviation 2.45 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Component Summary Change to Endpoint | 3.86 units on a scale | Standard Deviation 8.66 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Component Summary Baseline (N=455,N=377) | 23.93 units on a scale | Standard Deviation 8.76 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Component Summary Change to Endpoint | 14.67 units on a scale | Standard Deviation 11.77 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Functioning Baseline (N=457,N=377) | 23.59 units on a scale | Standard Deviation 4.75 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Functioning Change to Endpoint | 2.39 units on a scale | Standard Deviation 4.4 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Component Summary Baseline (N=455,N=377) | 43.55 units on a scale | Standard Deviation 9.46 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Bodily Pain Change from Baseline to Endpoint | 1.61 units on a scale | Standard Deviation 2.5 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Physical Baseline (N=457,N=377) | 5.24 units on a scale | Standard Deviation 1.47 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Physical Change to Endpoint | 1.06 units on a scale | Standard Deviation 1.78 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Emotional Baseline (N=456,N=377) | 3.42 units on a scale | Standard Deviation 0.8 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Emotional Change to Endpoint | 1.11 units on a scale | Standard Deviation 1.31 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | General Health Perceptions Baseline(N=456,N=377) | 13.66 units on a scale | Standard Deviation 3.62 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | General Health Perceptions Change to Endpoint | 2.93 units on a scale | Standard Deviation 3.74 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Health Baseline (N=456,N=377) | 12.62 units on a scale | Standard Deviation 4.13 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Health Change from Baseline to Endpoint | 6.45 units on a scale | Standard Deviation 5.31 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Social Function Baseline (N=460,N=377) | 4.77 units on a scale | Standard Deviation 1.74 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Social Function Change from Baseline to Endpoint | 2.12 units on a scale | Standard Deviation 2.04 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Vitality Baseline (N=457,N=377) | 8.85 units on a scale | Standard Deviation 3.26 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Vitality Change from Baseline to Endpoint | 4.51 units on a scale | Standard Deviation 4.22 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Rate Current Health Baseline (N=460,N=377) | 3.88 units on a scale | Standard Deviation 0.85 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Rate Current Health Change to Endpoint | -0.72 units on a scale | Standard Deviation 0.95 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Health Compared to Year Ago Baseline (N=460,N=377) | 3.67 units on a scale | Standard Deviation 0.99 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Health Compared to Year Ago Change to Endpoint | -1.18 units on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Health Compared to Year Ago Baseline (N=460,N=377) | 2.37 units on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Component Summary Baseline (N=455,N=377) | 48.05 units on a scale | Standard Deviation 8.65 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | General Health Perceptions Baseline(N=456,N=377) | 17.03 units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Component Summary Change to Endpoint | 0.03 units on a scale | Standard Deviation 7.63 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Vitality Baseline (N=457,N=377) | 13.84 units on a scale | Standard Deviation 3.79 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Component Summary Baseline (N=455,N=377) | 39.83 units on a scale | Standard Deviation 10.68 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | General Health Perceptions Change to Endpoint | 0.58 units on a scale | Standard Deviation 3.52 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Component Summary Change to Endpoint | 3.98 units on a scale | Standard Deviation 12.63 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Rate Current Health Change to Endpoint | -0.01 units on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Functioning Baseline (N=457,N=377) | 26.28 units on a scale | Standard Deviation 4.05 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Health Baseline (N=456,N=377) | 19.60 units on a scale | Standard Deviation 4.39 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Physical Functioning Change to Endpoint | 0.28 units on a scale | Standard Deviation 3.42 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Vitality Change from Baseline to Endpoint | 0.84 units on a scale | Standard Deviation 4.4 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Bodily Pain Baseline (N=460,N=377) | 8.61 units on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Mental Health Change from Baseline to Endpoint | 1.30 units on a scale | Standard Deviation 5.34 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Bodily Pain Change from Baseline to Endpoint | 0.07 units on a scale | Standard Deviation 2.39 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Health Compared to Year Ago Change to Endpoint | -0.34 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Physical Baseline (N=457,N=377) | 6.48 units on a scale | Standard Deviation 1.54 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Social Function Baseline (N=460,N=377) | 7.05 units on a scale | Standard Deviation 1.8 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Physical Change to Endpoint | 0.20 units on a scale | Standard Deviation 1.74 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Rate Current Health Baseline (N=460,N=377) | 3.03 units on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Emotional Baseline (N=456,N=377) | 4.65 units on a scale | Standard Deviation 1.25 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Social Function Change from Baseline to Endpoint | 0.65 units on a scale | Standard Deviation 2.19 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Role Limitations:Emotional Change to Endpoint | 0.34 units on a scale | Standard Deviation 1.49 |
p-value: <0.001t-test, 2 sided
p-value: 0.947t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.118t-test, 2 sided
p-value: 0.55t-test, 2 sided
p-value: 0.029t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.002t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.815t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Physical Component Summary | -0.45 units on a scale | Standard Error 0.7 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Mental Component Summary | -1.11 units on a scale | Standard Error 1.11 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Physical Functioning | 0.06 units on a scale | Standard Error 0.28 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Bodily Pain | -0.42 units on a scale | Standard Error 0.22 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Role Limitations: Physical | 0.01 units on a scale | Standard Error 0.14 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Role Limitations: Emotional | -0.03 units on a scale | Standard Error 0.11 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-General Health Perceptions | -0.23 units on a scale | Standard Error 0.33 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Mental Health | -0.44 units on a scale | Standard Error 0.49 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Social Function | -0.14 units on a scale | Standard Error 0.18 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Vitality | -0.77 units on a scale | Standard Error 0.38 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Rate Current Health | 0.03 units on a scale | Standard Error 0.08 |
| Duloxetine | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Health Compared to Year Ago | 0.19 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Rate Current Health | 0.08 units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Physical Component Summary | 0.33 units on a scale | Standard Error 0.76 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-General Health Perceptions | -0.61 units on a scale | Standard Error 0.36 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Mental Component Summary | -5.74 units on a scale | Standard Error 1.2 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Vitality | -1.38 units on a scale | Standard Error 0.41 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Physical Functioning | -0.07 units on a scale | Standard Error 0.31 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Mental Health | -2.60 units on a scale | Standard Error 0.53 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Bodily Pain | -0.19 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Health Compared to Year Ago | 0.34 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Role Limitations: Physical | -0.41 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Social Function | -0.50 units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Change from Baseline-Role Limitations: Emotional | -0.46 units on a scale | Standard Error 0.11 |
p-value: 0.24t-test, 2 sided
p-value: 0.142t-test, 2 sided
p-value: 0.415t-test, 2 sided
p-value: 0.002t-test, 2 sided
p-value: 0.731t-test, 2 sided
p-value: 0.438t-test, 2 sided
p-value: 0.029t-test, 2 sided
p-value: 0.003t-test, 2 sided
p-value: 0.391t-test, 2 sided
p-value: 0.001t-test, 2 sided
p-value: 0.615t-test, 2 sided
p-value: 0.218t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1 to 5 Baseline (N=220,N=197) | 21.41 units on a scale | Standard Deviation 5.17 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1 to 5 Change to Endpoint | -1.31 units on a scale | Standard Deviation 3.91 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1&2 Baseline (N=285,N=239) | 9.31 units on a scale | Standard Deviation 2.08 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1&2 Change to Endpoint | -0.69 units on a scale | Standard Deviation 1.91 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 1-Sex Drive Baseline (N=286,N=239) | 4.92 units on a scale | Standard Deviation 1.12 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 1-Sex Drive Change to Endpoint | -0.46 units on a scale | Standard Deviation 1.05 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 2-Arousal Baseline (N=286,N=239) | 4.40 units on a scale | Standard Deviation 1.13 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 2-Arousal Change to Endpoint | -0.22 units on a scale | Standard Deviation 1.07 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 3-Lubrication/Erection Baseline (N=224,N=198) | 3.97 units on a scale | Standard Deviation 1.26 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 3-Lubrication/Erection Change to Endpoint | -0.19 units on a scale | Standard Deviation 0.98 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 4-Orgasm Baseline (N=224,N=198) | 4.33 units on a scale | Standard Deviation 1.19 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item4-Orgasm Change to Endpoint | -0.13 units on a scale | Standard Deviation 1.02 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 5-Satisfaction Baseline (N=226,N=198) | 3.93 units on a scale | Standard Deviation 1.39 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 5-Satisfaction Change to Endpoint | -0.18 units on a scale | Standard Deviation 1.18 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 4-Orgasm Baseline (N=224,N=198) | 4.06 units on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1 to 5 Baseline (N=220,N=197) | 19.31 units on a scale | Standard Deviation 4.94 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 2-Arousal Change to Endpoint | -0.25 units on a scale | Standard Deviation 1.02 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1 to 5 Change to Endpoint | -0.99 units on a scale | Standard Deviation 4.38 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 5-Satisfaction Baseline (N=226,N=198) | 3.58 units on a scale | Standard Deviation 1.31 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1&2 Baseline (N=285,N=239) | 8.42 units on a scale | Standard Deviation 2.28 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 3-Lubrication/Erection Baseline (N=224,N=198) | 3.57 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Sum Items 1&2 Change to Endpoint | -0.56 units on a scale | Standard Deviation 1.92 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item4-Orgasm Change to Endpoint | -0.28 units on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 1-Sex Drive Baseline (N=286,N=239) | 4.34 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 3-Lubrication/Erection Change to Endpoint | -0.10 units on a scale | Standard Deviation 1.07 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 1-Sex Drive Change to Endpoint | -0.31 units on a scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 5-Satisfaction Change to Endpoint | -0.10 units on a scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Item 2-Arousal Baseline (N=286,N=239) | 4.08 units on a scale | Standard Deviation 1.19 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.005t-test, 2 sided
p-value: 0.05t-test, 2 sided
p-value: 0.022t-test, 2 sided
p-value: 0.002t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.186t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.308t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1 to 5 Baseline (N=117,N=97) | 17.57 units on a scale | Standard Deviation 4.88 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1 to 5 Change to Endpoint | 0.13 units on a scale | Standard Deviation 5.08 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1&2 Baseline (N=135, N=109) | 7.47 units on a scale | Standard Deviation 2.19 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1&2 Change to Endpoint | -0.19 units on a scale | Standard Deviation 2.32 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 1-Sex Drive Baseline (N=136,N=109) | 3.91 units on a scale | Standard Deviation 1.2 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 1-Sex Drive Change to Endpoint | -0.15 units on a scale | Standard Deviation 1.3 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 2-Arousal Baseline (N=135, N=109) | 3.56 units on a scale | Standard Deviation 1.11 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 2-Arousal Change to Endpoint | -0.02 units on a scale | Standard Deviation 1.17 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 3-Lubrication/Erection Baseline (N=124,N=99) | 3.43 units on a scale | Standard Deviation 1.13 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 3-Lubrication Change to Endpoint | -0.02 units on a scale | Standard Deviation 1.15 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 4-Orgasm Baseline (N=120,N=98) | 3.38 units on a scale | Standard Deviation 1.1 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 4-Orgasm Change to Endpoint | 0.32 units on a scale | Standard Deviation 1.3 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 5-Satisfaction Baseline (N=118,N=97) | 3.36 units on a scale | Standard Deviation 1.17 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 5-Satisfaction Change to Endpoint | 0.05 units on a scale | Standard Deviation 1.29 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 4-Orgasm Baseline (N=120,N=98) | 3.60 units on a scale | Standard Deviation 1.03 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1 to 5 Baseline (N=117,N=97) | 17.26 units on a scale | Standard Deviation 4.51 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 2-Arousal Change to Endpoint | -0.18 units on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1 to 5 Change to Endpoint | -0.67 units on a scale | Standard Deviation 3.97 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 5-Satisfaction Baseline (N=118,N=97) | 3.32 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1&2 Baseline (N=135, N=109) | 7.16 units on a scale | Standard Deviation 1.96 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 3-Lubrication/Erection Baseline (N=124,N=99) | 3.27 units on a scale | Standard Deviation 1.02 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Sum Items 1&2 Change to Endpoint | -0.39 units on a scale | Standard Deviation 1.76 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 4-Orgasm Change to Endpoint | -0.15 units on a scale | Standard Deviation 1.01 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 1-Sex Drive Baseline (N=136,N=109) | 3.68 units on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 3-Lubrication Change to Endpoint | -0.04 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 1-Sex Drive Change to Endpoint | -0.21 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 5-Satisfaction Change to Endpoint | -0.15 units on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Item 2-Arousal Baseline (N=135, N=109) | 3.48 units on a scale | Standard Deviation 0.95 |
p-value: 0.785t-test, 2 sided
p-value: 0.354t-test, 2 sided
p-value: 0.17t-test, 2 sided
p-value: 0.825t-test, 2 sided
p-value: 0.877t-test, 2 sided
p-value: 0.009t-test, 2 sided
p-value: 0.67t-test, 2 sided
p-value: 0.1t-test, 2 sided
p-value: 0.021t-test, 2 sided
p-value: 0.047t-test, 2 sided
p-value: 0.023t-test, 2 sided
p-value: 0.668t-test, 2 sided
p-value: 0.136t-test, 2 sided
p-value: 0.152t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 1 - Sex Drive (N=77,N=79) | -0.08 units on a scale | Standard Error 1.11 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 3 - Lubrication/Erection (N=63,N=67) | -0.21 units on a scale | Standard Error 0.92 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Change from Baseline:Sum Items 1&2 (N=77,N=79) | -0.19 units on a scale | Standard Error 1.9 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 4 - Orgasm (N=63,N=67) | -0.10 units on a scale | Standard Error 0.96 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 2 - Arousal (N=77,N=79) | -0.12 units on a scale | Standard Error 0.95 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 5 - Satisfaction (N=63,N=67) | -0.05 units on a scale | Standard Error 1.25 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Change from Baseline:Sum Items 1 to 5 (N=63,N=66) | -0.65 units on a scale | Standard Error 4.14 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 5 - Satisfaction (N=63,N=67) | -0.40 units on a scale | Standard Error 1.21 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Change from Baseline:Sum Items 1 to 5 (N=63,N=66) | -0.47 units on a scale | Standard Error 4.34 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Change from Baseline:Sum Items 1&2 (N=77,N=79) | 0.34 units on a scale | Standard Error 1.91 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 1 - Sex Drive (N=77,N=79) | 0.18 units on a scale | Standard Error 1.07 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 2 - Arousal (N=77,N=79) | 0.16 units on a scale | Standard Error 1.06 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 3 - Lubrication/Erection (N=63,N=67) | -0.15 units on a scale | Standard Error 1.21 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Item 4 - Orgasm (N=63,N=67) | -0.15 units on a scale | Standard Error 1.06 |
p-value: 0.979t-test, 2 sided
p-value: 0.132t-test, 2 sided
p-value: 0.18t-test, 2 sided
p-value: 0.163t-test, 2 sided
p-value: 0.844t-test, 2 sided
p-value: 0.609t-test, 2 sided
p-value: 0.071t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 1-Sex Drive (N=39,N=29) | -0.17 units on a scale | Standard Error 0.13 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 3-Lubrication/Erection (N=38,N=29) | -0.32 units on a scale | Standard Error 0.14 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Change from Baseline: Sum Items 1&2 (N=39,N=29) | -0.25 units on a scale | Standard Error 0.22 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 4-Orgasm (N=36,N=29) | -0.08 units on a scale | Standard Error 0.14 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 2-Arousal (N=39,N=29) | -0.09 units on a scale | Standard Error 0.12 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 5-Satisfaction (N=35,N=29) | -0.13 units on a scale | Standard Error 0.11 |
| Duloxetine | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Change from Baseline: Sum Items 1 to 5 (N=35,N=29) | -0.97 units on a scale | Standard Error 0.47 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 5-Satisfaction (N=35,N=29) | -0.04 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Change from Baseline: Sum Items 1 to 5 (N=35,N=29) | -0.77 units on a scale | Standard Error 0.58 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Change from Baseline: Sum Items 1&2 (N=39,N=29) | 0.03 units on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 1-Sex Drive (N=39,N=29) | -0.02 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 2-Arousal (N=39,N=29) | 0.07 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 3-Lubrication/Erection (N=38,N=29) | -0.10 units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Item 4-Orgasm (N=36,N=29) | -0.43 units on a scale | Standard Error 0.17 |
p-value: 0.384t-test, 2 sided
p-value: 0.268t-test, 2 sided
p-value: 0.773t-test, 2 sided
p-value: 0.405t-test, 2 sided
p-value: 0.443t-test, 2 sided
p-value: 0.093t-test, 2 sided
p-value: 0.566t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Baseline | 4.49 units on a scale | Standard Deviation 0.6 |
| Duloxetine | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Change from Baseline to Endpoint | -2.30 units on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Baseline | 1.83 units on a scale | Standard Deviation 0.39 |
| Placebo | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Change from Baseline to Endpoint | -0.07 units on a scale | Standard Deviation 0.93 |
p-value: <0.001t-test, 2 sided
p-value: 0.153t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase | 0.24 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase | 0.84 units on a scale | Standard Error 0.1 |
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Anxiety Baseline | 7.71 units on a scale | Standard Deviation 1.99 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Anxiety Change from Baseline to Endpoint | -4.52 units on a scale | Standard Deviation 2.63 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Core Baseline | 8.81 units on a scale | Standard Deviation 1.78 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Core Change from Baseline to Endpoint | -5.97 units on a scale | Standard Deviation 2.69 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Maier Baseline | 11.44 units on a scale | Standard Deviation 1.95 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Maier Change from Baseline to Endpoint | -7.46 units on a scale | Standard Deviation 3.29 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Retardation Baseline | 7.76 units on a scale | Standard Deviation 1.53 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Retardation Change from Baseline to Endpoint | -4.61 units on a scale | Standard Deviation 2.37 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Sleep Baseline | 3.80 units on a scale | Standard Deviation 1.59 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Sleep Change from Baseline to Endpoint | -2.37 units on a scale | Standard Deviation 1.92 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Depressed Mood Baseline | 2.78 units on a scale | Standard Deviation 0.58 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Depressed Mood Change from Baseline to Endpoint | -1.86 units on a scale | Standard Deviation 0.98 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Depressed Mood Baseline | 0.64 units on a scale | Standard Deviation 0.57 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Anxiety Baseline | 2.51 units on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Retardation Baseline | 2.43 units on a scale | Standard Deviation 1.37 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Anxiety Change from Baseline to Endpoint | -0.11 units on a scale | Standard Deviation 2.24 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Sleep Change from Baseline to Endpoint | -0.07 units on a scale | Standard Deviation 1.38 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Core Baseline | 2.00 units on a scale | Standard Deviation 1.35 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Retardation Change from Baseline to Endpoint | -0.48 units on a scale | Standard Deviation 2.22 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Core Change from Baseline to Endpoint | -0.29 units on a scale | Standard Deviation 2.47 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Depressed Mood Change from Baseline to Endpoint | -0.05 units on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Maier Baseline | 2.91 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Sleep Baseline | 1.11 units on a scale | Standard Deviation 1.11 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Maier Change from Baseline to Endpoint | -0.29 units on a scale | Standard Deviation 2.97 |
p-value: <0.001t-test, 2 sided
p-value: 0.334t-test, 2 sided
p-value: 0.019t-test, 2 sided
p-value: 0.046t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.319t-test, 2 sided
p-value: 0.275t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Anxiety | 0.46 units on a scale | Standard Error 0.2 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Core | 0.75 units on a scale | Standard Error 0.22 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Maier | 0.91 units on a scale | Standard Error 0.29 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Retardation | 0.59 units on a scale | Standard Error 0.2 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Sleep | 0.13 units on a scale | Standard Error 0.12 |
| Duloxetine | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Depressed Mood | 0.27 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Sleep | 0.71 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Anxiety | 1.54 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Retardation | 1.49 units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Core | 1.74 units on a scale | Standard Error 0.24 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Depressed Mood | 0.67 units on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Change from Baseline to Endpoint in Maier | 2.25 units on a scale | Standard Error 0.31 |
p-value: <0.001t-test, 2 sided
p-value: 0.002t-test, 2 sided
p-value: 0.002t-test, 2 sided
p-value: 0.003t-test, 2 sided
p-value: 0.001t-test, 2 sided
p-value: 0.003t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Global Score Baseline (N=449,N=378) | 19.30 units on a scale | Standard Deviation 6.58 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Global Score Change from Baseline to Endpoint | -7.88 units on a scale | Standard Deviation 8.06 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Work/School Item Baseline (N=452,N=378) | 6.52 units on a scale | Standard Deviation 2.52 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Work/School Item Change from Baseline to Endpoint | -2.61 units on a scale | Standard Deviation 2.87 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Social Life Item Baseline (N=452,N=378) | 6.45 units on a scale | Standard Deviation 2.42 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Social Life Item Change from Baseline to Endpoint | -2.69 units on a scale | Standard Deviation 2.9 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Family Life Item Baseline (N=452,N=378) | 6.35 units on a scale | Standard Deviation 2.44 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Family Life Item Change from Baseline to Endpoint | -2.59 units on a scale | Standard Deviation 3.07 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Family Life Item Change from Baseline to Endpoint | -0.63 units on a scale | Standard Deviation 2.72 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Global Score Baseline (N=449,N=378) | 10.72 units on a scale | Standard Deviation 7.21 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Social Life Item Baseline (N=452,N=378) | 3.50 units on a scale | Standard Deviation 2.53 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Global Score Change from Baseline to Endpoint | -2.01 units on a scale | Standard Deviation 7.67 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Family Life Item Baseline (N=452,N=378) | 3.54 units on a scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Work/School Item Baseline (N=452,N=378) | 3.64 units on a scale | Standard Deviation 2.64 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Social Life Item Change from Baseline to Endpoint | -0.64 units on a scale | Standard Deviation 2.79 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Work/School Item Change from Baseline to Endpoint | -0.71 units on a scale | Standard Deviation 2.86 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Global Score | -0.05 units on a scale | Standard Error 0.71 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Work/School | 0.03 units on a scale | Standard Error 0.26 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Social Life | 0.02 units on a scale | Standard Error 0.25 |
| Duloxetine | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Family Life | -0.10 units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Family Life | 0.67 units on a scale | Standard Error 0.27 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Global Score | 2.06 units on a scale | Standard Error 0.77 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Social Life | 0.56 units on a scale | Standard Error 0.27 |
| Placebo | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Change from Baseline to Endpoint in Work/School | 0.83 units on a scale | Standard Error 0.28 |
p-value: 0.029t-test, 2 sided
p-value: 0.022t-test, 2 sided
p-value: 0.11t-test, 2 sided
p-value: 0.021t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases
The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | Baseline | 12.64 units on a scale | Standard Deviation 5.09 |
| Duloxetine | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | Change from Baseline to Endpoint | -5.37 units on a scale | Standard Deviation 5.42 |
| Placebo | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | Baseline | 6.88 units on a scale | Standard Deviation 5.13 |
| Placebo | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | Change from Baseline to Endpoint | -0.35 units on a scale | Standard Deviation 4.8 |
p-value: <0.001t-test, 2 sided
p-value: 0.157t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase
The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase | 0.79 units on a scale | Standard Error 0.39 |
| Placebo | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase | 0.81 units on a scale | Standard Error 0.4 |
p-value: 0.979t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Overall Pain Baseline (N=450, N=410) | 34.36 units on a scale | Standard Deviation 26.16 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Overall Pain Change from Baseline to Endpoint | -16.34 units on a scale | Standard Deviation 26.95 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Headache Baseline (N=450, N=410) | 29.74 units on a scale | Standard Deviation 28.08 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Headache Change from Baseline to Endpoint | -14.83 units on a scale | Standard Deviation 28.04 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Back Pain Baseline (N=450, N=410) | 28.79 units on a scale | Standard Deviation 27.8 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Back Pain Change from Baseline to Endpoint | -13.64 units on a scale | Standard Deviation 25.66 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Shoulder Pain Baseline (N=446, N=410) | 24.06 units on a scale | Standard Deviation 27.23 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Shoulder Pain Change from Baseline to Endpoint | -10.47 units on a scale | Standard Deviation 24.25 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Interference-DailyActivities Baseline(N=445,N=410) | 33.28 units on a scale | Standard Deviation 28.31 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Intereference Change from Baseline to Endpoint | -16.79 units on a scale | Standard Deviation 29.77 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Pain While Awake Baseline (N=446, N=410) | 38.18 units on a scale | Standard Deviation 29.29 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Pain While Awake Change from Baseline to Endpoint | -17.66 units on a scale | Standard Deviation 31.22 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Pain While Awake Baseline (N=446, N=410) | 19.22 units on a scale | Standard Deviation 25.63 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Overall Pain Baseline (N=450, N=410) | 17.29 units on a scale | Standard Deviation 20.2 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Shoulder Pain Baseline (N=446, N=410) | 13.49 units on a scale | Standard Deviation 21.95 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Overall Pain Change from Baseline to Endpoint | 1.16 units on a scale | Standard Deviation 21.33 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Intereference Change from Baseline to Endpoint | 1.00 units on a scale | Standard Deviation 21.43 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Headache Baseline (N=450, N=410) | 14.80 units on a scale | Standard Deviation 20.53 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Shoulder Pain Change from Baseline to Endpoint | -0.39 units on a scale | Standard Deviation 20.84 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Headache Change from Baseline to Endpoint | 0.04 units on a scale | Standard Deviation 21.88 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Pain While Awake Change from Baseline to Endpoint | 0.06 units on a scale | Standard Deviation 25.61 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Back Pain Baseline (N=450, N=410) | 15.61 units on a scale | Standard Deviation 22.63 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Interference-DailyActivities Baseline(N=445,N=410) | 15.59 units on a scale | Standard Deviation 21.62 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Back Pain Change from Baseline to Endpoint | -0.00 units on a scale | Standard Deviation 20.95 |
p-value: <0.001t-test, 2 sided
p-value: 0.273t-test, 2 sided
p-value: 0.968t-test, 2 sided
p-value: 0.998t-test, 2 sided
p-value: 0.703t-test, 2 sided
p-value: 0.346t-test, 2 sided
p-value: 0.963t-test, 2 sided
Secondary
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Overall Pain | 3.92 units on a scale | Standard Error 1.78 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Headache | 4.77 units on a scale | Standard Error 1.72 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Back Pain | 1.77 units on a scale | Standard Error 1.65 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Shoulder Pain | 0.51 units on a scale | Standard Error 1.55 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change: Interference with Daily Activities | 3.16 units on a scale | Standard Error 1.74 |
| Duloxetine | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline in Pain While Awake | 3.64 units on a scale | Standard Error 2.1 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change: Interference with Daily Activities | 2.81 units on a scale | Standard Error 1.82 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Overall Pain | 4.57 units on a scale | Standard Error 1.86 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Shoulder Pain | 3.02 units on a scale | Standard Error 1.62 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Headache | 2.80 units on a scale | Standard Error 1.8 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline in Pain While Awake | 4.69 units on a scale | Standard Error 2.19 |
| Placebo | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Change from Baseline to Endpoint in Back Pain | 3.40 units on a scale | Standard Error 1.72 |
p-value: 0.792t-test, 2 sided
p-value: 0.407t-test, 2 sided
p-value: 0.475t-test, 2 sided
p-value: 0.241t-test, 2 sided
p-value: 0.885t-test, 2 sided
p-value: 0.717t-test, 2 sided
Secondary
Loss of Response at Any Time
Loss of response was defined as a HAMD-17 total score \>9 and a CGI-Severity score \>2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.
Time frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)
Population: Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Loss of Response at Any Time | 44 participants |
| Placebo | Loss of Response at Any Time | 66 participants |
p-value: 0.003Cochran-Mantel-Haenszel
Secondary
Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases | 2.12 units on a scale | Standard Deviation 0.86 |
| Placebo | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases | 1.76 units on a scale | Standard Deviation 0.91 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: Week 86 (Maintenance Phase)
Population: Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase | 1.72 units on a scale | Standard Error 0.11 |
| Placebo | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase | 2.34 units on a scale | Standard Error 0.11 |
p-value: <0.001t-test, 2 sided
Secondary
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
Worsening occurs if patient had a \>=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score \>=3 at any time during the double-blind maintenance therapy phase.
Time frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Population: Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=7 days (N=142, N=140) | 2.07 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=14 days (N=140, N=138) | 3.45 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=21 days (N=136, N=130) | 5.53 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=28 days (N=132, N=125) | 7.63 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=56 days (N=124, N=105) | 11.89 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=84 days (N=114, N=88) | 16.99 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=112 days (N=105, N=81) | 21.48 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=140 days (N=100, N=72) | 23.02 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=168 days (N=95, N=70) | 24.61 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=196 days (N=93, N=67) | 26.19 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=224 days (N=90, N=65) | 28.57 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=252 days (N=84, N=60) | 31.04 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=280 days (N=81, N=60) | 31.88 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=308 days (N=78, N=59) | 31.88 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=336 days (N=77, N=56) | 31.88 percentage of participants |
| Duloxetine | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=364 days (N=75, N=51) | 33.65 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=364 days (N=75, N=51) | 51.33 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=7 days (N=142, N=140) | 1.41 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=168 days (N=95, N=70) | 42.47 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=14 days (N=140, N=138) | 1.41 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=280 days (N=81, N=60) | 45.80 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=21 days (N=136, N=130) | 7.12 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=196 days (N=93, N=67) | 44.14 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=28 days (N=132, N=125) | 9.30 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=336 days (N=77, N=56) | 49.42 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=56 days (N=124, N=105) | 22.57 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=224 days (N=90, N=65) | 45.80 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=84 days (N=114, N=88) | 31.86 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=308 days (N=78, N=59) | 46.71 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=112 days (N=105, N=81) | 35.07 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=252 days (N=84, N=60) | 45.80 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | t=140 days (N=100, N=72) | 40.82 percentage of participants |
p-value: 0.003Log Rank
Secondary
Recurrence Count
Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.
Time frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)
Population: Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Duloxetine | Recurrence Count | 21 participants |
| Placebo | Recurrence Count | 47 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Average Number of Hours Worked In a Week Baseline | 0.36 hours | Standard Deviation 0.1 |
| Duloxetine | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Change in Average Number of Hours Worked In a Week | 0.00 hours | Standard Deviation 0.06 |
| Placebo | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Average Number of Hours Worked In a Week Baseline | 0.36 hours | Standard Deviation 0.1 |
| Placebo | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Change in Average Number of Hours Worked In a Week | 0.01 hours | Standard Deviation 0.08 |
p-value: 0.506t-test, 2 sided
p-value: 0.057t-test, 2 sided
Secondary
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients who work for pay. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase | -0.00 hours | Standard Error 0.01 |
| Placebo | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase | -0.00 hours | Standard Error 0.01 |
p-value: 0.826t-test, 2 sided
Secondary
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Number of Missed Paid Work Hours Baseline | 1.77 hours | Standard Deviation 2.07 |
| Duloxetine | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Change in Number of Missed Paid Work Hours | 0.46 hours | Standard Deviation 2.25 |
| Placebo | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Number of Missed Paid Work Hours Baseline | 2.67 hours | Standard Deviation 2.27 |
| Placebo | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Change in Number of Missed Paid Work Hours | -0.52 hours | Standard Deviation 2.01 |
p-value: 0.105t-test, 2 sided
p-value: 0.174t-test, 2 sided
Secondary
Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase | 0.27 hours | Standard Error 0.28 |
| Placebo | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase | -0.75 hours | Standard Error 0.35 |
p-value: 0.037t-test, 2 sided
Secondary
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Time frame: Week 0 through Week10 (Acute) through Week 34 (Continuation)
Population: Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: Other Mental Health Care Worker wasn't included in table (1 patient in Acute). Other Health Care Worker wasn't included in table (2 patients in Continuation).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Psychiatrist Visits (N=91,N=65) | 0.03 visits | Standard Deviation 0.03 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Other Specialist Physician Visits (N=42,N=38) | -0.00 visits | Standard Deviation 0.02 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Psychologist/Therapist Visits (N=19,N=11) | 0.01 visits | Standard Deviation 0.04 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Other (Specified by Patient) Visits (N=3,N=3) | 0.04 visits | Standard Deviation 0.07 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Primary Health Care Provider Visits (N=94,N=99) | -0.00 visits | Standard Deviation 0.03 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Other (Specified by Patient) Visits (N=3,N=3) | -0.07 visits | Standard Deviation 0.1 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Primary Health Care Provider Visits (N=94,N=99) | -0.00 visits | Standard Deviation 0.03 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Psychiatrist Visits (N=91,N=65) | -0.03 visits | Standard Deviation 0.04 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Psychologist/Therapist Visits (N=19,N=11) | -0.00 visits | Standard Deviation 0.06 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Other Specialist Physician Visits (N=42,N=38) | 0.01 visits | Standard Deviation 0.03 |
p-value: 0.838t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.236t-test, 2 sided
p-value: 0.145t-test, 2 sided
p-value: 0.423t-test, 2 sided
p-value: 0.325t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.915t-test, 2 sided
p-value: 0.223t-test, 2 sided
p-value: 0.362t-test, 2 sided
Secondary
Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.
Time frame: Week 34 through Week 86 (Maintenance Phase)
Population: Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Psychiatrist Visits (N=33,N=23) | -0.01 visits | Standard Error 0 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Other Specialist Physician Visits (N=25,N=25) | 0.00 visits | Standard Error 0.01 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Psychologist/Therapist Visits (N=8,N=7) | -0.02 visits | Standard Error 0.01 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Other (Specified by Patient) Visits (N=5,N=3) | 0.04 visits | Standard Error 0.02 |
| Duloxetine | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Primary Health Care Provider Visits (N=47,N=47) | -0.00 visits | Standard Error 0 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Other (Specified by Patient) Visits (N=5,N=3) | 0.00 visits | Standard Error 0 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Primary Health Care Provider Visits (N=47,N=47) | -0.00 visits | Standard Error 0 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Psychiatrist Visits (N=33,N=23) | -0.01 visits | Standard Error 0.01 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Psychologist/Therapist Visits (N=8,N=7) | -0.01 visits | Standard Error 0.01 |
| Placebo | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Other Specialist Physician Visits (N=25,N=25) | -0.00 visits | Standard Error 0 |
p-value: 0.462t-test, 2 sided
p-value: 0.668t-test, 2 sided
p-value: 0.746t-test, 2 sided
p-value: 0.511t-test, 2 sided
p-value: 0.271t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | Baseline | 21.81 Units per Liter | Standard Deviation 11.56 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | Change to Endpoint | 2.52 Units per Liter | Standard Deviation 15.4 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | Baseline | 22.12 Units per Liter | Standard Deviation 11.11 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | Change to Endpoint | -0.38 Units per Liter | Standard Deviation 12.53 |
p-value: 0.035ANOVA
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase | Baseline | 43.05 grams per Liter | Standard Deviation 3.31 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase | Change to Endpoint | -0.61 grams per Liter | Standard Deviation 2.9 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase | Baseline | 42.43 grams per Liter | Standard Deviation 3.04 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase | Change to Endpoint | -0.57 grams per Liter | Standard Deviation 2.81 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase | Baseline | 24.41 millimoles per Liter | Standard Deviation 2.64 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase | Change to Endpoint | 1.04 millimoles per Liter | Standard Deviation 2.93 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase | Baseline | 2.03 micromoles per Liter | Standard Deviation 1.04 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase | Change to Endpoint | -0.12 micromoles per Liter | Standard Deviation 0.85 |
p-value: 0.004t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase | Baseline | 8.68 micromoles per Liter | Standard Deviation 5.1 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase | Change to Endpoint | -0.50 micromoles per Liter | Standard Deviation 3.84 |
p-value: 0.01t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase | Baseline | 2.46 millimoles per Liter | Standard Deviation 0.1 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase | Change to Endpoint | -0.01 millimoles per Liter | Standard Deviation 0.1 |
p-value: 0.007t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase | Baseline | 2.45 millimoles per Liter | Standard Deviation 0.1 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase | Change to Endpoint | -0.01 millimoles per Liter | Standard Deviation 0.1 |
p-value: 0.003t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | Baseline | 2.43 millimoles per Liter | Standard Deviation 0.1 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | Change to Endpoint | -0.04 millimoles per Liter | Standard Deviation 0.1 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | Baseline | 2.43 millimoles per Liter | Standard Deviation 0.08 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | Change to Endpoint | -0.01 millimoles per Liter | Standard Deviation 0.09 |
p-value: 0.011ANOVA
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase | Baseline | 103.73 millimoles per Liter | Standard Deviation 2.66 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase | Change to Endpoint | -0.29 millimoles per Liter | Standard Deviation 2.81 |
p-value: 0.035t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase | Baseline | 0.13 Giga per Liter | Standard Deviation 0.09 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase | Change to Endpoint | 0.01 Giga per Liter | Standard Deviation 0.09 |
p-value: 0.021t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase | Baseline | 4.74 Tera per Liter | Standard Deviation 0.45 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase | Change to Endpoint | -0.06 Tera per Liter | Standard Deviation 0.25 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase | Baseline | 29.25 Units per Liter | Standard Deviation 36.3 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase | Change to Endpoint | -5.12 Units per Liter | Standard Deviation 20.53 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase | Baseline | 24.13 Units per Liter | Standard Deviation 24.96 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase | Change to Endpoint | 2.11 Units per Liter | Standard Deviation 17.11 |
p-value: 0.015t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Fasting Glucose Baseline (N=120,N=112) | 5.40 millimoles per Liter | Standard Deviation 0.72 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Fasting Glucose Change to Endpoint | 0.07 millimoles per Liter | Standard Deviation 0.71 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Non-Fasting Glucose Baseline (N=41,N=39) | 5.68 millimoles per Liter | Standard Deviation 0.91 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Non-Fasting Glucose Change to Endpoint | -0.20 millimoles per Liter | Standard Deviation 1.18 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Non-Fasting Glucose Change to Endpoint | 0.62 millimoles per Liter | Standard Deviation 1.67 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Fasting Glucose Baseline (N=120,N=112) | 5.47 millimoles per Liter | Standard Deviation 1.09 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Non-Fasting Glucose Baseline (N=41,N=39) | 5.74 millimoles per Liter | Standard Deviation 2.34 |
| Placebo | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Fasting Glucose Change to Endpoint | 0.03 millimoles per Liter | Standard Deviation 1.01 |
p-value: 0.744ANOVA
p-value: 0.03ANOVA
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase | Baseline | 0.43 actual count | Standard Deviation 0.04 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase | Change to Endpoint | -0.00 actual count | Standard Deviation 0.03 |
p-value: 0.019t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase | Baseline | 0.42 Actual count | Standard Deviation 0.04 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase | Change to Endpoint | -0.00 Actual count | Standard Deviation 0.03 |
p-value: 0.021t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase | Baseline | 8.81 millimoles per Liter | Standard Deviation 0.8 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase | Change to Endpoint | -0.07 millimoles per Liter | Standard Deviation 0.48 |
p-value: 0.005t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase | Baseline | 8.73 millimoles per Liter | Standard Deviation 0.8 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase | Change to Endpoint | -0.14 millimoles per Liter | Standard Deviation 0.47 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase | Baseline | 6.40 Giga per Liter | Standard Deviation 1.69 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase | Change to Endpoint | 0.17 Giga per Liter | Standard Deviation 1.57 |
p-value: 0.032t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase | Baseline | 3.61 millimoles per Liter | Standard Deviation 1.07 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase | Change to Endpoint | -0.14 millimoles per Liter | Standard Deviation 0.73 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase | Baseline | 20.73 millimoles per Liter | Standard Deviation 0.87 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase | Change to Endpoint | -0.18 millimoles per Liter | Standard Deviation 0.99 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase | Baseline | 89.33 femtoliters | Standard Deviation 5.1 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase | Change to Endpoint | 0.45 femtoliters | Standard Deviation 4 |
p-value: 0.028t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase | Baseline | 0.35 Giga per Liter | Standard Deviation 0.12 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase | Change to Endpoint | 0.02 Giga per Liter | Standard Deviation 0.12 |
p-value: 0.008t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase | Baseline | 261.08 Giga per Liter | Standard Deviation 60.89 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase | Change to Endpoint | 4.23 Giga per Liter | Standard Deviation 40.22 |
p-value: 0.031t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase | Baseline | 141.21 millimoles per Liter | Standard Deviation 2.65 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase | Change to Endpoint | -0.64 millimoles per Liter | Standard Deviation 2.96 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase | Baseline | 73.59 grams per Liter | Standard Deviation 4.4 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase | Change to Endpoint | -1.18 grams per Liter | Standard Deviation 4.11 |
p-value: <0.001t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase
Time frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase | Baseline | 72.47 grams per Liter | Standard Deviation 3.93 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase | Change to Endpoint | -0.38 grams per Liter | Standard Deviation 3.77 |
p-value: 0.046t-test, 2 sided
Secondary
Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase
Time frame: Week 0 and Week 10
Population: Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase | Baseline | 297.05 micromoles per Liter | Standard Deviation 81.68 |
| Duloxetine | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase | Change to Endpoint | -10.64 micromoles per Liter | Standard Deviation 49.42 |
p-value: <0.001t-test, 2 sided
Secondary
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
Time frame: Every Visit from Week 0 up to Week 10 (Acute)
Population: Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Patients with >= 1 Adverse Event | 349 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Nausea | 150 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Headache | 79 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Dry mouth | 76 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Hyperhidrosis | 76 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Fatigue | 60 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Constipation | 48 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Dizziness | 41 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Diarrhoea | 38 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Vomiting | 28 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Insomnia | 27 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Decreased appetite | 26 participants |
Secondary
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
Time frame: Every Visit from Week 10 up to Week 34 (Continuation)
Population: Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Back pain | 7 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Nasopharyngitis | 7 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Diarrhoea | 10 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Patients with >= 1 Adverse Event | 102 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Hyperhidrosis | 8 participants |
| Duloxetine | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Headache | 21 participants |
| Placebo | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Hyperhidrosis | 12 participants |
| Placebo | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Back pain | 4 participants |
| Placebo | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Diarrhoea | 6 participants |
| Placebo | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Headache | 12 participants |
| Placebo | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Patients with >= 1 Adverse Event | 83 participants |
| Placebo | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Nasopharyngitis | 10 participants |
| Duloxetine 120 mg | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Diarrhoea | 2 participants |
| Duloxetine 120 mg | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Patients with >= 1 Adverse Event | 59 participants |
| Duloxetine 120 mg | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Headache | 6 participants |
| Duloxetine 120 mg | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Nasopharyngitis | 9 participants |
| Duloxetine 120 mg | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Hyperhidrosis | 5 participants |
| Duloxetine 120 mg | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Back pain | 8 participants |
Secondary
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Systolic Blood Pressure Baseline | 125.03 mm Hg | Standard Deviation 14.65 |
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Systolic Blood Pressure Change to Endpoint | 0.25 mm Hg | Standard Deviation 12.62 |
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Diastolic Blood Pressure Baseline | 77.52 mm Hg | Standard Deviation 9.54 |
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Diastolic Blood Pressure Change to Endpoint | 0.72 mm Hg | Standard Deviation 8.68 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Diastolic Blood Pressure Change to Endpoint | -0.57 mm Hg | Standard Deviation 9.18 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Systolic Blood Pressure Baseline | 124.72 mm Hg | Standard Deviation 13.84 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Diastolic Blood Pressure Baseline | 78.28 mm Hg | Standard Deviation 9.19 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Systolic Blood Pressure Change to Endpoint | 0.77 mm Hg | Standard Deviation 12.83 |
p-value: 0.659t-test, 2 sided
p-value: 0.064t-test, 2 sided
p-value: 0.224t-test, 2 sided
p-value: 0.21t-test, 2 sided
Secondary
Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | Change from Baseline: Systolic Blood Pressure | 1.70 mm Hg | Standard Error 13.44 |
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | Change from Baseline: Diastolic Blood Pressure | -0.23 mm Hg | Standard Error 9.72 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | Change from Baseline: Systolic Blood Pressure | -1.11 mm Hg | Standard Error 11.59 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | Change from Baseline: Diastolic Blood Pressure | -0.11 mm Hg | Standard Error 8.69 |
p-value: 0.134t-test, 2 sided
p-value: 0.816t-test, 2 sided
Secondary
Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | Pulse Baseline | 71.76 beats per minute | Standard Deviation 9.26 |
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | Pulse Change from Baseline to Endpoint | 1.42 beats per minute | Standard Deviation 9.18 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | Pulse Baseline | 72.79 beats per minute | Standard Deviation 9.5 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | Pulse Change from Baseline to Endpoint | 1.75 beats per minute | Standard Deviation 10.39 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase | -1.86 beats per minute | Standard Error 0.76 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase | -1.72 beats per minute | Standard Error 0.78 |
p-value: 0.891t-test, 2 sided
Secondary
Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases
Time frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Population: Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | Weight Baseline | 74.74 kilograms | Standard Deviation 16.25 |
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | Weight Change from Baseline to Endpoint | -0.69 kilograms | Standard Deviation 2.12 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | Weight Baseline | 74.22 kilograms | Standard Deviation 15.89 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | Weight Change from Baseline to Endpoint | 0.88 kilograms | Standard Deviation 3.29 |
p-value: <0.001t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase
Time frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
Population: Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase | 0.88 kilograms | Standard Error 0.36 |
| Placebo | Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase | 0.39 kilograms | Standard Error 0.37 |
p-value: 0.314t-test, 2 sided