Major Depressive Disorder
Conditions
Brief summary
Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.
Interventions
DRUGDuloxetine hydrochloride
DRUGPlacebo
Sponsors
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients * Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD) * Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2 * Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2 * Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion criteria
* Patients judged clinically to be at serious suicidal risk in the opinion of the investigator * Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia * Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD * Patients with uncontrolled narrow-angle glaucoma * Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) | baseline, 8 weeks | Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Baseline, 8 weeks, 12 weeks, 9 months | 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). Please see baseline demographics for subscale total scores. |
| Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | Baseline, 12 weeks, 9 months | — |
| Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | Baseline, 12 weeks, 9 months | Measures depressed mood on a scale of 0 (absent) to 4 (very depressed). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | Baseline, 12 weeks, 9 months | Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | Baseline, 12 weeks, 9 Months | Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | Baseline, 12 weeks, 9 months | Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | Baseline, 12 weeks, 9 months | Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | Baseline, 12 weeks, 9 months | Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed). |
| Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities | Baseline, 9 months | Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | Baseline, 12 weeks, 9 months | Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | Baseline, 12 weeks, 9 months | Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting) |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | Baseline, 12 weeks, 9 months | Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed) |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | Baseline, 12 weeks, 9 months | Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | Baseline, 12 weeks, 9 months | Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | Baseline, 12 weeks, 9 months | Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | Baseline, 12 weeks, 9 months | Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | Baseline, 12 weeks, 9 months | Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | Baseline, 12 weeks, 9 months | Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | Baseline, 12 weeks, 9 months | Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | Baseline, 12 weeks, 9 months | Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | Baseline, 12 weeks, 9 months | Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | Baseline, 12 weeks, 9 months | Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | Baseline, 12 weeks, 9 months | Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | Baseline, 12 weeks, 9 months | Measures paranoid symptoms on a scale of 0 (none) to 2 (severe). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | Baseline, 12 weeks, 9 months | Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled). |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | Baseline, 12 weeks, 9 months | Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe). |
| Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Baseline, 12 weeks | The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig). |
| Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Baseline, 9 months | The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig). |
| Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Baseline, 12 weeks | 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. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. |
| Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Baseline, 9 months | 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. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. |
| Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Over 12 weeks | Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis. |
| Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect | over 12 weeks | For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated. |
| Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | over 12 weeks | Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis. |
| Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect | Over 12 weeks | For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated. |
| Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | Baseline, 12 weeks, 9 months | A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. |
| Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 weeks, 9 months | Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. |
| Probability of Response at 12 Week Endpoint | 12 weeks | Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score. |
| Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Baseline, 12 weeks, 9 months | Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered). |
| Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | Baseline, 12 weeks, 9 months | 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 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | Baseline, 12 weeks, 9 months | A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. |
| Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | Baseline, 12 weeks, 9 months | A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60. |
| Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Baseline, 12 weeks, 9 months | Sitting systolic and diastolic blood pressure. |
| Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | Baseline, 12 weeks, 9 months | — |
| Change From Baseline to 12 Week and 9 Month Endpoints in Weight | Baseline, 12 weeks, 9 months | — |
| Abnormal Vital Signs at Anytime Over 12 Weeks | over 12 weeks | — |
| Abnormal Vital Signs at Anytime Over 9 Months | over 9 months | — |
| Abnormal Vital Signs at 12 Week Endpoint | 12 weeks | — |
| Abnormal Vital Signs at 9 Month Endpoint | 9 months | — |
| Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Baseline, 12 weeks, 9 months | — |
| Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Baseline, 12 weeks, 9 months | — |
| Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | Baseline, 12 weeks, 9 months | — |
| Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Baseline, 12 weeks, 9 months | — |
| Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | Baseline, 12 weeks, 9 months | Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe). |
| Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase | baseline, 9 months | — |
| Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin | Baseline, 9 months | — |
| Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | over 3 months | The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same. |
| Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | over 9 months | — |
| Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | 9 months | — |
| Summary of Adverse Events Leading to Discontinuation | over 9 months | — |
| Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | Baseline, 12 weeks, 9 months | — |
Countries
Puerto Rico, United States
Participant flow
Pre-assignment details
Study HMFS comprises two identical trials (identified as Group A and Group B). Study Period I was a screening period. Study Period II was a 9-month double-blind treatment period. Study Period III was an optional double-blind 2-week discontinuation/taper period.
Participants by arm
| Arm | Count |
|---|---|
| Group A - Duloxetine duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | 257 |
| Group A - Placebo placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | 127 |
| Group B - Duloxetine duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months | 261 |
| Group B - Placebo placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). | 131 |
| Total | 776 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 32 | 16 | 28 | 13 |
| Overall Study | Death | 0 | 0 | 1 | 2 |
| Overall Study | Lack of Efficacy | 17 | 18 | 11 | 9 |
| Overall Study | Lost to Follow-up | 48 | 23 | 48 | 22 |
| Overall Study | Physician Decision | 11 | 1 | 3 | 2 |
| Overall Study | Protocol Violation | 8 | 1 | 2 | 3 |
| Overall Study | Sponsor Decision | 0 | 1 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 40 | 24 | 43 | 21 |
Baseline characteristics
| Characteristic | Group A - Duloxetine | Group A - Placebo | Group B - Duloxetine | Group B - Placebo | Total |
|---|---|---|---|---|---|
| Age Continuous | 42.2 years STANDARD_DEVIATION 12.2 | 43.7 years STANDARD_DEVIATION 12.5 | 44.7 years STANDARD_DEVIATION 12.2 | 43.9 years STANDARD_DEVIATION 11.9 | 43.6 years STANDARD_DEVIATION 12.2 |
| Body Height | 168.1 centimeters STANDARD_DEVIATION 10.1 | 168.5 centimeters STANDARD_DEVIATION 9.2 | 169.0 centimeters STANDARD_DEVIATION 9.7 | 168.8 centimeters STANDARD_DEVIATION 9.4 | 168.6 centimeters STANDARD_DEVIATION 9.7 |
| Body Weight | 88.8 kilograms STANDARD_DEVIATION 23.7 | 84.9 kilograms STANDARD_DEVIATION 22.5 | 88.6 kilograms STANDARD_DEVIATION 26.6 | 86.4 kilograms STANDARD_DEVIATION 23.5 | 87.7 kilograms STANDARD_DEVIATION 24.5 |
| Evaluation - 16-Item Quick Inventory of Depressive Symptomatology (QIDS16) Total Score | 14.7 units on a scale STANDARD_DEVIATION 4.1 | 13.7 units on a scale STANDARD_DEVIATION 4.4 | 15.0 units on a scale STANDARD_DEVIATION 4.4 | 14.7 units on a scale STANDARD_DEVIATION 3.8 | 14.6 units on a scale STANDARD_DEVIATION 4.2 |
| Evaluation - 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score | 22.9 units on a scale STANDARD_DEVIATION 4.3 | 22.8 units on a scale STANDARD_DEVIATION 3.7 | 22.8 units on a scale STANDARD_DEVIATION 4.5 | 22.9 units on a scale STANDARD_DEVIATION 4.9 | 22.8 units on a scale STANDARD_DEVIATION 4.4 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Anxiety/Somatization Subscale Score | 6.8 units on a scale STANDARD_DEVIATION 2.1 | 6.9 units on a scale STANDARD_DEVIATION 1.9 | 7.1 units on a scale STANDARD_DEVIATION 2.3 | 7.3 units on a scale STANDARD_DEVIATION 2.4 | 7.0 units on a scale STANDARD_DEVIATION 2.2 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Bech Subscale Score | 12.6 units on a scale STANDARD_DEVIATION 2 | 12.5 units on a scale STANDARD_DEVIATION 1.7 | 12.4 units on a scale STANDARD_DEVIATION 1.9 | 12.3 units on a scale STANDARD_DEVIATION 2.2 | 12.5 units on a scale STANDARD_DEVIATION 2 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 10:Anxiety (Psychic) | 2.1 units on a scale STANDARD_DEVIATION 0.8 | 2.1 units on a scale STANDARD_DEVIATION 0.7 | 2.1 units on a scale STANDARD_DEVIATION 0.8 | 2.2 units on a scale STANDARD_DEVIATION 0.8 | 2.1 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 11:Anxiety (Somatic) | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 1.5 units on a scale STANDARD_DEVIATION 0.8 | 1.6 units on a scale STANDARD_DEVIATION 0.9 | 1.6 units on a scale STANDARD_DEVIATION 0.9 | 1.5 units on a scale STANDARD_DEVIATION 0.9 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 13:Somatic Symptoms/General | 1.6 units on a scale STANDARD_DEVIATION 0.6 | 1.7 units on a scale STANDARD_DEVIATION 0.5 | 1.7 units on a scale STANDARD_DEVIATION 0.5 | 1.7 units on a scale STANDARD_DEVIATION 0.6 | 1.7 units on a scale STANDARD_DEVIATION 0.5 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 14:Genital Symptoms | 1.3 units on a scale STANDARD_DEVIATION 0.8 | 1.2 units on a scale STANDARD_DEVIATION 0.9 | 1.3 units on a scale STANDARD_DEVIATION 0.8 | 1.1 units on a scale STANDARD_DEVIATION 0.9 | 1.2 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 15:Hypochondriasis | 0.7 units on a scale STANDARD_DEVIATION 0.8 | 0.7 units on a scale STANDARD_DEVIATION 0.8 | 1.0 units on a scale STANDARD_DEVIATION 0.9 | 1.1 units on a scale STANDARD_DEVIATION 0.9 | 0.9 units on a scale STANDARD_DEVIATION 0.9 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 16:Loss of Weight | 0.3 units on a scale STANDARD_DEVIATION 0.6 | 0.2 units on a scale STANDARD_DEVIATION 0.5 | 0.3 units on a scale STANDARD_DEVIATION 0.6 | 0.4 units on a scale STANDARD_DEVIATION 0.7 | 0.3 units on a scale STANDARD_DEVIATION 0.6 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 17:Insight | 0.2 units on a scale STANDARD_DEVIATION 0.4 | 0.2 units on a scale STANDARD_DEVIATION 0.4 | 0.1 units on a scale STANDARD_DEVIATION 0.2 | 0.0 units on a scale STANDARD_DEVIATION 0.2 | 0.1 units on a scale STANDARD_DEVIATION 0.4 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 18A:Diurnal Variation | 0.8 units on a scale STANDARD_DEVIATION 0.8 | 0.9 units on a scale STANDARD_DEVIATION 0.9 | 1.0 units on a scale STANDARD_DEVIATION 0.9 | 1.0 units on a scale STANDARD_DEVIATION 0.9 | 0.9 units on a scale STANDARD_DEVIATION 0.9 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 1:Depressed Mood | 3.0 units on a scale STANDARD_DEVIATION 0.6 | 2.9 units on a scale STANDARD_DEVIATION 0.6 | 2.9 units on a scale STANDARD_DEVIATION 0.6 | 2.9 units on a scale STANDARD_DEVIATION 0.5 | 2.9 units on a scale STANDARD_DEVIATION 0.6 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 20:Paranoid Symptoms | 0.2 units on a scale STANDARD_DEVIATION 0.5 | 0.2 units on a scale STANDARD_DEVIATION 0.5 | 0.2 units on a scale STANDARD_DEVIATION 0.5 | 0.2 units on a scale STANDARD_DEVIATION 0.4 | 0.2 units on a scale STANDARD_DEVIATION 0.5 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 22B:Helplessness | 1.4 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.7 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 23B:Hopelessness | 1.3 units on a scale STANDARD_DEVIATION 0.8 | 1.3 units on a scale STANDARD_DEVIATION 0.9 | 1.3 units on a scale STANDARD_DEVIATION 0.8 | 1.3 units on a scale STANDARD_DEVIATION 0.9 | 1.3 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 24B:Worthlessness | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.6 units on a scale STANDARD_DEVIATION 1.1 | 1.6 units on a scale STANDARD_DEVIATION 1.1 | 1.5 units on a scale STANDARD_DEVIATION 1 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 2:Feelings of Guilt | 1.8 units on a scale STANDARD_DEVIATION 0.7 | 2.0 units on a scale STANDARD_DEVIATION 0.7 | 1.8 units on a scale STANDARD_DEVIATION 0.6 | 1.7 units on a scale STANDARD_DEVIATION 0.8 | 1.8 units on a scale STANDARD_DEVIATION 0.7 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 3:Suicide | 0.6 units on a scale STANDARD_DEVIATION 0.7 | 0.7 units on a scale STANDARD_DEVIATION 0.7 | 0.6 units on a scale STANDARD_DEVIATION 0.8 | 0.6 units on a scale STANDARD_DEVIATION 0.8 | 0.6 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 4:Insomnia Early | 1.5 units on a scale STANDARD_DEVIATION 0.8 | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 1.4 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 5:Insomnia Middle | 1.5 units on a scale STANDARD_DEVIATION 0.7 | 1.5 units on a scale STANDARD_DEVIATION 0.6 | 1.4 units on a scale STANDARD_DEVIATION 0.8 | 1.5 units on a scale STANDARD_DEVIATION 0.7 | 1.5 units on a scale STANDARD_DEVIATION 0.7 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 6:Insomnia Late | 1.2 units on a scale STANDARD_DEVIATION 0.8 | 1.3 units on a scale STANDARD_DEVIATION 0.8 | 1.1 units on a scale STANDARD_DEVIATION 0.8 | 1.1 units on a scale STANDARD_DEVIATION 0.8 | 1.2 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 7:Work and Activities | 2.9 units on a scale STANDARD_DEVIATION 0.5 | 2.8 units on a scale STANDARD_DEVIATION 0.6 | 2.8 units on a scale STANDARD_DEVIATION 0.5 | 2.8 units on a scale STANDARD_DEVIATION 0.5 | 2.8 units on a scale STANDARD_DEVIATION 0.5 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 8:Retardation | 1.1 units on a scale STANDARD_DEVIATION 0.7 | 1.0 units on a scale STANDARD_DEVIATION 0.7 | 1.1 units on a scale STANDARD_DEVIATION 0.8 | 1.1 units on a scale STANDARD_DEVIATION 0.9 | 1.1 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 9:Agitation | 0.9 units on a scale STANDARD_DEVIATION 0.9 | 0.9 units on a scale STANDARD_DEVIATION 0.8 | 0.9 units on a scale STANDARD_DEVIATION 0.9 | 1.0 units on a scale STANDARD_DEVIATION 0.9 | 0.9 units on a scale STANDARD_DEVIATION 0.9 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Maier Subscale Score | 11.8 units on a scale STANDARD_DEVIATION 2.2 | 11.7 units on a scale STANDARD_DEVIATION 1.9 | 11.6 units on a scale STANDARD_DEVIATION 2.2 | 11.6 units on a scale STANDARD_DEVIATION 2.4 | 11.7 units on a scale STANDARD_DEVIATION 2.2 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Retardation Subscale Score | 8.2 units on a scale STANDARD_DEVIATION 1.6 | 8.0 units on a scale STANDARD_DEVIATION 1.6 | 8.0 units on a scale STANDARD_DEVIATION 1.6 | 7.9 units on a scale STANDARD_DEVIATION 1.6 | 8.1 units on a scale STANDARD_DEVIATION 1.6 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Sleep Subscale Score | 4.2 units on a scale STANDARD_DEVIATION 1.6 | 4.3 units on a scale STANDARD_DEVIATION 1.5 | 3.9 units on a scale STANDARD_DEVIATION 1.7 | 4.0 units on a scale STANDARD_DEVIATION 1.5 | 4.1 units on a scale STANDARD_DEVIATION 1.6 |
| Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Total Score | 28.6 units on a scale STANDARD_DEVIATION 6 | 28.6 units on a scale STANDARD_DEVIATION 5.5 | 28.7 units on a scale STANDARD_DEVIATION 6.2 | 29.0 units on a scale STANDARD_DEVIATION 6.7 | 28.7 units on a scale STANDARD_DEVIATION 6.1 |
| Evaluation - 24-Item Hamilton Depression Rating Scale - Item 12:Somatic Symptoms/Gastrointestinal | 0.7 units on a scale STANDARD_DEVIATION 0.7 | 0.6 units on a scale STANDARD_DEVIATION 0.7 | 0.6 units on a scale STANDARD_DEVIATION 0.7 | 0.7 units on a scale STANDARD_DEVIATION 0.7 | 0.7 units on a scale STANDARD_DEVIATION 0.7 |
| Evaluation - 24-Item Hamilton Depression Rating Scale - Item 18B:Diurnal Variation-Severity | 0.8 units on a scale STANDARD_DEVIATION 0.8 | 0.9 units on a scale STANDARD_DEVIATION 0.9 | 0.9 units on a scale STANDARD_DEVIATION 0.8 | 1.0 units on a scale STANDARD_DEVIATION 0.9 | 0.9 units on a scale STANDARD_DEVIATION 0.8 |
| Evaluation - 24-Item Hamilton Depression Rating Scale - Item 19: Depersonalization and Derealization | 0.2 units on a scale STANDARD_DEVIATION 0.6 | 0.3 units on a scale STANDARD_DEVIATION 0.6 | 0.2 units on a scale STANDARD_DEVIATION 0.5 | 0.2 units on a scale STANDARD_DEVIATION 0.5 | 0.2 units on a scale STANDARD_DEVIATION 0.6 |
| Evaluation - 24-Item Hamilton Depression Rating Scale - Item 21:Obsessional and Compulsive Symptoms | 0.1 units on a scale STANDARD_DEVIATION 0.4 | 0.1 units on a scale STANDARD_DEVIATION 0.4 | 0.1 units on a scale STANDARD_DEVIATION 0.4 | 0.1 units on a scale STANDARD_DEVIATION 0.4 | 0.1 units on a scale STANDARD_DEVIATION 0.4 |
| Evaluation - Brief Profile of Mood States (BPOMS) Anger-Hostility Score | 8.9 units on a scale STANDARD_DEVIATION 5.4 | 9.0 units on a scale STANDARD_DEVIATION 5.4 | 9.5 units on a scale STANDARD_DEVIATION 5.1 | 9.5 units on a scale STANDARD_DEVIATION 5.4 | 9.2 units on a scale STANDARD_DEVIATION 5.3 |
| Evaluation - Brief Profile of Mood States (BPOMS) Confusion-Bewilderment Score | 9.7 units on a scale STANDARD_DEVIATION 4 | 9.6 units on a scale STANDARD_DEVIATION 3.9 | 9.8 units on a scale STANDARD_DEVIATION 4.1 | 10.1 units on a scale STANDARD_DEVIATION 3.8 | 9.8 units on a scale STANDARD_DEVIATION 4 |
| Evaluation - Brief Profile of Mood States (BPOMS) Depression-Dejection Score | 11.8 units on a scale STANDARD_DEVIATION 4.8 | 11.5 units on a scale STANDARD_DEVIATION 4.8 | 12.3 units on a scale STANDARD_DEVIATION 4.6 | 12.0 units on a scale STANDARD_DEVIATION 4.2 | 12.0 units on a scale STANDARD_DEVIATION 4.7 |
| Evaluation - Brief Profile of Mood States (BPOMS) Fatigue-Inertia Score | 12.8 units on a scale STANDARD_DEVIATION 4.6 | 12.3 units on a scale STANDARD_DEVIATION 4.8 | 13.5 units on a scale STANDARD_DEVIATION 4.7 | 13.2 units on a scale STANDARD_DEVIATION 4.5 | 13.0 units on a scale STANDARD_DEVIATION 4.7 |
| Evaluation - Brief Profile of Mood States (BPOMS) Tension-Anxiety Score | 9.5 units on a scale STANDARD_DEVIATION 4.6 | 9.2 units on a scale STANDARD_DEVIATION 4.6 | 10.0 units on a scale STANDARD_DEVIATION 5 | 10.4 units on a scale STANDARD_DEVIATION 4.6 | 9.8 units on a scale STANDARD_DEVIATION 4.7 |
| Evaluation - Brief Profile of Mood States (BPOMS) Total Score | 49.0 units on a scale STANDARD_DEVIATION 19.2 | 47.5 units on a scale STANDARD_DEVIATION 18.7 | 51.8 units on a scale STANDARD_DEVIATION 19.3 | 51.8 units on a scale STANDARD_DEVIATION 18.7 | 50.2 units on a scale STANDARD_DEVIATION 19.1 |
| Evaluation - Brief Profile of Mood States (BPOMS) Vigor-Activity Score | 3.4 units on a scale STANDARD_DEVIATION 3.1 | 3.9 units on a scale STANDARD_DEVIATION 3.1 | 3.6 units on a scale STANDARD_DEVIATION 3.5 | 3.4 units on a scale STANDARD_DEVIATION 3 | 3.5 units on a scale STANDARD_DEVIATION 3.2 |
| Evaluation - Clinical Global Impressions of Severity Scale (CGI-S) Score | 4.6 units on a scale STANDARD_DEVIATION 0.6 | 4.5 units on a scale STANDARD_DEVIATION 0.6 | 4.7 units on a scale STANDARD_DEVIATION 0.7 | 4.7 units on a scale STANDARD_DEVIATION 0.7 | 4.6 units on a scale STANDARD_DEVIATION 0.7 |
| Evaluation - Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire | 28.4 units on a scale STANDARD_DEVIATION 6 | 26.8 units on a scale STANDARD_DEVIATION 6.1 | 28.6 units on a scale STANDARD_DEVIATION 6.1 | 28.6 units on a scale STANDARD_DEVIATION 5.4 | 28.2 units on a scale STANDARD_DEVIATION 6 |
| Evaluation - Pain Numerical Rating Scale (NRS) Score Item 1 | 4.3 units on a scale STANDARD_DEVIATION 2.8 | 4.1 units on a scale STANDARD_DEVIATION 2.7 | 4.5 units on a scale STANDARD_DEVIATION 3.1 | 4.5 units on a scale STANDARD_DEVIATION 2.8 | 4.4 units on a scale STANDARD_DEVIATION 2.9 |
| Evaluation - Pain Numerical Rating Scale (NRS) Score Item 7 | 4.7 units on a scale STANDARD_DEVIATION 3 | 4.5 units on a scale STANDARD_DEVIATION 3.1 | 4.7 units on a scale STANDARD_DEVIATION 3.2 | 4.9 units on a scale STANDARD_DEVIATION 3.2 | 4.7 units on a scale STANDARD_DEVIATION 3.1 |
| Evaluation - Sheehan Disability Scale (SDS) Item 1 | 5.5 units on a scale STANDARD_DEVIATION 2.8 | 5.4 units on a scale STANDARD_DEVIATION 2.7 | 5.6 units on a scale STANDARD_DEVIATION 2.7 | 5.3 units on a scale STANDARD_DEVIATION 2.8 | 5.5 units on a scale STANDARD_DEVIATION 2.7 |
| Evaluation - Sheehan Disability Scale (SDS) Item 2 | 6.6 units on a scale STANDARD_DEVIATION 2.4 | 6.2 units on a scale STANDARD_DEVIATION 2.8 | 6.4 units on a scale STANDARD_DEVIATION 2.8 | 5.9 units on a scale STANDARD_DEVIATION 2.5 | 6.3 units on a scale STANDARD_DEVIATION 2.6 |
| Evaluation - Sheehan Disability Scale (SDS) Item 3 | 6.5 units on a scale STANDARD_DEVIATION 2.5 | 6.0 units on a scale STANDARD_DEVIATION 2.6 | 6.2 units on a scale STANDARD_DEVIATION 2.6 | 6.0 units on a scale STANDARD_DEVIATION 2.5 | 6.2 units on a scale STANDARD_DEVIATION 2.6 |
| Evaluation - Sheehan Disability Scale (SDS) Total Score | 19.0 units on a scale STANDARD_DEVIATION 6.5 | 17.8 units on a scale STANDARD_DEVIATION 7.3 | 18.4 units on a scale STANDARD_DEVIATION 7.1 | 17.5 units on a scale STANDARD_DEVIATION 7 | 18.3 units on a scale STANDARD_DEVIATION 6.9 |
| Evaluation - Social Adaptation Self-Evaluation Scale (SASS) Total | 27.2 units on a scale STANDARD_DEVIATION 7.3 | 29.1 units on a scale STANDARD_DEVIATION 8.4 | 27.6 units on a scale STANDARD_DEVIATION 8.2 | 29.3 units on a scale STANDARD_DEVIATION 8.2 | 28.0 units on a scale STANDARD_DEVIATION 8 |
| History - Age at First Episode | 30.0 years STANDARD_DEVIATION 13.2 | 31.2 years STANDARD_DEVIATION 13.7 | 30.7 years STANDARD_DEVIATION 13.6 | 30.0 years STANDARD_DEVIATION 12.6 | 30.4 years STANDARD_DEVIATION 13.3 |
| History - Atypical Depression No | 250 participants | 122 participants | 242 participants | 124 participants | 738 participants |
| History - Atypical Depression Yes | 7 participants | 5 participants | 19 participants | 7 participants | 38 participants |
| History - How Long was Last Major Depressive Disorder (MDD) Episode | 4.7 weeks STANDARD_DEVIATION 6.3 | 5.0 weeks STANDARD_DEVIATION 7.4 | 5.2 weeks STANDARD_DEVIATION 6.9 | 6.5 weeks STANDARD_DEVIATION 14.5 | 5.2 weeks STANDARD_DEVIATION 8.6 |
| History - Interval Between Start of Current and Remission of Last MDD Episode | 13.2 weeks STANDARD_DEVIATION 20.1 | 12.5 weeks STANDARD_DEVIATION 24.3 | 13.1 weeks STANDARD_DEVIATION 22.1 | 13.1 weeks STANDARD_DEVIATION 22.2 | 13.0 weeks STANDARD_DEVIATION 21.8 |
| History - Melancholic Depression No | 123 participants | 56 participants | 114 participants | 60 participants | 353 participants |
| History - Melancholic Depression Yes | 134 participants | 71 participants | 147 participants | 71 participants | 423 participants |
| History - Number of Previous Episodes | 4.0 number of previous episodes STANDARD_DEVIATION 4.8 | 3.8 number of previous episodes STANDARD_DEVIATION 4.3 | 4.9 number of previous episodes STANDARD_DEVIATION 5.4 | 5.2 number of previous episodes STANDARD_DEVIATION 5.4 | 4.5 number of previous episodes STANDARD_DEVIATION 5.1 |
| History - Seasonal Pattern in Major Depressive Disorder (MDD) if ≥3 Previous MDD Episodes Missing Response | 34 participants | 19 participants | 20 participants | 15 participants | 88 participants |
| History - Seasonal Pattern in Major Depressive Disorder (MDD) if ≥3 Previous MDD Episodes No | 220 participants | 105 participants | 232 participants | 112 participants | 669 participants |
| History - Seasonal Pattern in Major Depressive Disorder (MDD) if ≥3 Previous MDD Episodes Yes | 3 participants | 3 participants | 9 participants | 4 participants | 19 participants |
| History - Time Since First Episode Date | 12.3 years STANDARD_DEVIATION 11.6 | 12.5 years STANDARD_DEVIATION 11.6 | 14.0 years STANDARD_DEVIATION 11.5 | 14.0 years STANDARD_DEVIATION 12 | 13.2 years STANDARD_DEVIATION 11.7 |
| History - Time Since Most Recent Episode | 44.0 weeks STANDARD_DEVIATION 60.2 | 48.8 weeks STANDARD_DEVIATION 69.5 | 51.4 weeks STANDARD_DEVIATION 103.3 | 59.2 weeks STANDARD_DEVIATION 111.2 | 49.8 weeks STANDARD_DEVIATION 87.3 |
| Race/Ethnicity African | 63 participants | 36 participants | 30 participants | 16 participants | 145 participants |
| Race/Ethnicity Caucasian | 160 participants | 73 participants | 172 participants | 81 participants | 486 participants |
| Race/Ethnicity East Asian | 3 participants | 5 participants | 3 participants | 1 participants | 12 participants |
| Race/Ethnicity Hispanic | 29 participants | 11 participants | 55 participants | 30 participants | 125 participants |
| Race/Ethnicity Native American | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity West Asian (Indian sub-continent) | 2 participants | 2 participants | 1 participants | 2 participants | 7 participants |
| Region of Enrollment Puerto Rico | 8 participants | 4 participants | 39 participants | 21 participants | 72 participants |
| Region of Enrollment United States | 249 participants | 123 participants | 222 participants | 110 participants | 704 participants |
| Sex: Female, Male Female | 155 Participants | 78 Participants | 169 Participants | 87 Participants | 489 Participants |
| Sex: Female, Male Male | 102 Participants | 49 Participants | 92 Participants | 44 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 497 / — | 237 / — |
| serious Total, serious adverse events | 18 / — | 14 / — |
Outcome results
Primary
Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)
Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
Time frame: baseline, 8 weeks
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) | -1.32 units on a scale | Standard Error 0.07 |
| Group A - Placebo | Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) | -1.07 units on a scale | Standard Error 0.11 |
| Group B - Duloxetine | Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) | -1.37 units on a scale | Standard Error 0.07 |
| Group B - Placebo | Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities) | -0.93 units on a scale | Standard Error 0.09 |
p-value: 0.051Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
Abnormal Vital Signs at 12 Week Endpoint
Time frame: 12 weeks
Population: Number of participants with a normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Sitting Systolic Blood Pressure - High | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Weight - Gain | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Weight - Loss | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Sitting Pulse Rate - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Weight - Loss | 1 participants |
| Group A - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Sitting Systolic Blood Pressure - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Weight - Gain | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Sitting Pulse Rate - High | 0 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Weight - Loss | 2 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Sitting Pulse Rate - High | 1 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Weight - Gain | 0 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Sitting Systolic Blood Pressure - High | 4 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 12 Week Endpoint | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Sitting Systolic Blood Pressure - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Weight - Gain | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Sitting Pulse Rate - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Weight - Loss | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 12 Week Endpoint | Sitting Diastolic Blood Pressure - High | 1 participants |
Secondary
Abnormal Vital Signs at 9 Month Endpoint
Time frame: 9 months
Population: Number of participants with a normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Sitting Systolic Blood Pressure - High | 1 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Weight - Gain | 2 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Weight - Loss | 5 participants |
| Group A - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Sitting Pulse - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Weight - Loss | 1 participants |
| Group A - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Sitting Systolic Blood Pressure - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Weight - Gain | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Sitting Pulse - High | 0 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Weight - Loss | 4 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Sitting Pulse - High | 1 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Weight - Gain | 3 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Sitting Systolic Blood Pressure - High | 4 participants |
| Group B - Duloxetine | Abnormal Vital Signs at 9 Month Endpoint | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Sitting Systolic Blood Pressure - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Weight - Gain | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Sitting Pulse - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Weight - Loss | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at 9 Month Endpoint | Sitting Diastolic Blood Pressure - High | 1 participants |
Secondary
Abnormal Vital Signs at Anytime Over 12 Weeks
Time frame: over 12 weeks
Population: Number of participants wtih a normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Systolic Blood Pressure - High | 3 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Gain | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Diastolic Blood Pressure - High | 2 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Loss | 0 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Pulse Rate - High | 1 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Loss | 1 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Systolic Blood Pressure - High | 1 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Gain | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Pulse Rate - High | 0 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Loss | 2 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Pulse Rate - High | 1 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Gain | 0 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Systolic Blood Pressure - High | 6 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Diastolic Blood Pressure - High | 2 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Systolic Blood Pressure - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Gain | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Pulse Rate - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Weight - Loss | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 12 Weeks | Sitting Diastolic Blood Pressure - High | 3 participants |
Secondary
Abnormal Vital Signs at Anytime Over 9 Months
Time frame: over 9 months
Population: Number of participants with a normal baseline and at least oone post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Loss | 5 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Pulse - High | 1 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Systolic Blood Pressure - High | 4 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Gain | 2 participants |
| Group A - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Diastolic Blood Pressure - High | 2 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Loss | 1 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Gain | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Systolic Blood Pressure - High | 2 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Pulse - High | 0 participants |
| Group A - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Diastolic Blood Pressure - High | 0 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Diastolic Blood Pressure - High | 4 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Pulse - High | 2 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Gain | 3 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Loss | 5 participants |
| Group B - Duloxetine | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Systolic Blood Pressure - High | 7 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Diastolic Blood Pressure - High | 3 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Systolic Blood Pressure - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Gain | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Sitting Pulse - High | 0 participants |
| Group B - Placebo | Abnormal Vital Signs at Anytime Over 9 Months | Weight - Loss | 0 participants |
Secondary
Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
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: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 12 Week Change | -1.93 units on a scale | Standard Error 0.08 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 9 Month Change (n=29, n=9, n=33, n=10) | -2.14 units on a scale | Standard Error 0.22 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.97 units on a scale | Standard Error 0.4 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 12 Week Change | -1.58 units on a scale | Standard Error 0.14 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 12 Week Change | -1.97 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 9 Month Change (n=29, n=9, n=33, n=10) | -2.61 units on a scale | Standard Error 0.21 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 12 Week Change | -1.25 units on a scale | Standard Error 0.15 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | 9 Month Change (n=29, n=9, n=33, n=10) | -2.23 units on a scale | Standard Error 0.37 |
p-value: 0.032Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.705Mixed Models Analysis
p-value: 0.388Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score
A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 12 Week Change | -6.31 units on a scale | Standard Deviation 0.34 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 9 Month Change (n=29, n=9, n=33, n=9) | -8.41 units on a scale | Standard Deviation 0.77 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 9 Month Change (n=29, n=9, n=33, n=9) | -6.85 units on a scale | Standard Deviation 1.36 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 12 Week Change | -5.65 units on a scale | Standard Deviation 0.55 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 12 Week Change | -6.54 units on a scale | Standard Deviation 0.33 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 9 Month Change (n=29, n=9, n=33, n=9) | -7.17 units on a scale | Standard Deviation 0.59 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 12 Week Change | -5.21 units on a scale | Standard Deviation 0.52 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score | 9 Month Change (n=29, n=9, n=33, n=9) | -6.15 units on a scale | Standard Deviation 1.11 |
p-value: 0.302Mixed Models Analysis
p-value: 0.029Mixed Models Analysis
p-value: 0.325Mixed Models Analysis
p-value: 0.423Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure
Sitting systolic and diastolic blood pressure.
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Systolic Blood Pressure (SBP) - 12 Week Change | -0.12 mm Hg | Standard Error 0.78 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Diastolic Blood Pressure (DBP) - 12 Week Change | 0.48 mm Hg | Standard Error 0.51 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | SBP - 9 Month Change (n=28, n=9, n=33, n=10) | -1.18 mm Hg | Standard Error 2.31 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | DBP - 9 Month Change (n=28, n=9, n=33, n=10) | -2.25 mm Hg | Standard Error 1.25 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Diastolic Blood Pressure (DBP) - 12 Week Change | -0.58 mm Hg | Standard Error 0.88 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | SBP - 9 Month Change (n=28, n=9, n=33, n=10) | -0.44 mm Hg | Standard Error 4.02 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | DBP - 9 Month Change (n=28, n=9, n=33, n=10) | 1.46 mm Hg | Standard Error 2.18 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Systolic Blood Pressure (SBP) - 12 Week Change | 0.05 mm Hg | Standard Error 1.33 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | SBP - 9 Month Change (n=28, n=9, n=33, n=10) | -2.22 mm Hg | Standard Error 1.63 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Diastolic Blood Pressure (DBP) - 12 Week Change | 1.97 mm Hg | Standard Error 0.61 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | DBP - 9 Month Change (n=28, n=9, n=33, n=10) | -1.52 mm Hg | Standard Error 1.47 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Systolic Blood Pressure (SBP) - 12 Week Change | 0.73 mm Hg | Standard Error 0.76 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | DBP - 9 Month Change (n=28, n=9, n=33, n=10) | -1.05 mm Hg | Standard Error 2.69 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Diastolic Blood Pressure (DBP) - 12 Week Change | -0.50 mm Hg | Standard Error 1 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | Systolic Blood Pressure (SBP) - 12 Week Change | -2.95 mm Hg | Standard Error 1.25 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure | SBP - 9 Month Change (n=28, n=9, n=33, n=10) | -0.54 mm Hg | Standard Error 2.91 |
p-value: 0.914Mixed Models Analysis
p-value: 0.011Mixed Models Analysis
p-value: 0.296Mixed Models Analysis
p-value: 0.034Mixed Models Analysis
p-value: 0.874Mixed Models Analysis
p-value: 0.614Mixed Models Analysis
p-value: 0.146Mixed Models Analysis
p-value: 0.877Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)
Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 12 Week Change | -1.15 units on a scale | Standard Error 0.06 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.23 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.13 units on a scale | Standard Error 0.2 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 12 Week Change | -0.90 units on a scale | Standard Error 0.1 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 12 Week Change | -1.15 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.41 units on a scale | Standard Error 0.12 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 12 Week Change | -0.81 units on a scale | Standard Error 0.1 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.70 units on a scale | Standard Error 0.22 |
p-value: 0.038Mixed Models Analysis
p-value: 0.002Mixed Models Analysis
p-value: 0.665Mixed Models Analysis
p-value: 0.253Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)
Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 12 Week Change | -0.61 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 9 Month Change (n=29, n=9, n=33, n=10) | -0.98 units on a scale | Standard Error 0.11 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 9 Month Change (n=29, n=9, n=33, n=10) | -0.94 units on a scale | Standard Error 0.19 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 12 Week Change | -0.65 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 12 Week Change | -0.68 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.20 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 12 Week Change | -0.57 units on a scale | Standard Error 0.1 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic) | 9 Month Change (n=29, n=9, n=33, n=10) | -1.18 units on a scale | Standard Error 0.14 |
p-value: 0.723Mixed Models Analysis
p-value: 0.312Mixed Models Analysis
p-value: 0.853Mixed Models Analysis
p-value: 0.913Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal
Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 12 Week Change | -0.44 units on a scale | Standard Error 0.03 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 9 Month Change (n=29, n=9, n=33, n=10) | -0.98 units on a scale | Standard Error 0.11 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 9 Month Change (n=29, n=9, n=33, n=10) | -0.94 units on a scale | Standard Error 0.19 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 12 Week Change | -0.52 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 12 Week Change | -0.40 units on a scale | Standard Error 0.03 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 9 Month Change (n=29, n=9, n=33, n=10) | -0.46 units on a scale | Standard Error 0.05 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 12 Week Change | -0.32 units on a scale | Standard Error 0.05 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal | 9 Month Change (n=29, n=9, n=33, n=10) | -0.47 units on a scale | Standard Error 0.09 |
p-value: 0.234Mixed Models Analysis
p-value: 0.216Mixed Models Analysis
p-value: 0.853Mixed Models Analysis
p-value: 0.908Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General
Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 12 Week Change | -0.91 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 9 Month Change (n=29, n=9, n=33, n=10) | -1.36 units on a scale | Standard Error 0.11 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 9 Month Change (n=29, n=9, n=33, n=10) | -1.18 units on a scale | Standard Error 0.2 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 12 Week Change | -0.88 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 12 Week Change | -0.75 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 9 Month Change (n=29, n=9, n=33, n=10) | -0.94 units on a scale | Standard Error 0.13 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 12 Week Change | -0.49 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General | 9 Month Change (n=29, n=9, n=33, n=10) | -0.83 units on a scale | Standard Error 0.25 |
p-value: 0.789Mixed Models Analysis
p-value: 0.012Mixed Models Analysis
p-value: 0.414Mixed Models Analysis
p-value: 0.717Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms
Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 12 Week Change | -0.57 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.89 units on a scale | Standard Error 0.13 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.77 units on a scale | Standard Error 0.22 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 12 Week Change | -0.54 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 12 Week Change | -0.55 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.68 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 12 Week Change | -0.40 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.30 units on a scale | Standard Error 0.15 |
p-value: 0.78Mixed Models Analysis
p-value: 0.152Mixed Models Analysis
p-value: 0.637Mixed Models Analysis
p-value: 0.024Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis
Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 12 Week Change | -0.36 units on a scale | Standard Error 0.04 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 9 Month Change (n=29, n=9, n=33, n=10) | -0.44 units on a scale | Standard Error 82.99 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 9 Month Change (n=29, n=9, n=33, n=10) | -0.53 units on a scale | Standard Error 144.4 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 12 Week Change | -0.41 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 12 Week Change | -0.52 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 9 Month Change (n=29, n=9, n=33, n=10) | -0.61 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 12 Week Change | -0.41 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis | 9 Month Change (n=29, n=9, n=33, n=10) | -0.41 units on a scale | Standard Error 0.16 |
p-value: 0.517Mixed Models Analysis
p-value: 0.256Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.268Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight
Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 12 Week Change | -0.21 units on a scale | Standard Error 0.02 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.44 units on a scale | Standard Error 82.99 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.53 units on a scale | Standard Error 144.4 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 12 Week Change | -0.20 units on a scale | Standard Error 0.04 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 12 Week Change | -0.25 units on a scale | Standard Error 0.02 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.61 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 12 Week Change | -0.24 units on a scale | Standard Error 0.04 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.41 units on a scale | Standard Error 0.16 |
p-value: 0.741Mixed Models Analysis
p-value: 0.722Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.268Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight
Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 12 Week Change | -0.08 units on a scale | Standard Error 0.01 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.44 units on a scale | Standard Error 82.99 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.53 units on a scale | Standard Error 144.4 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 12 Week Change | -0.07 units on a scale | Standard Error 0.02 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 12 Week Change | -0.01 units on a scale | Standard Error 0.01 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.61 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 12 Week Change | -0.01 units on a scale | Standard Error 0.02 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight | 9 Month Change (n=29, n=9, n=33, n=10) | -0.41 units on a scale | Standard Error 0.16 |
p-value: 0.723Mixed Models Analysis
p-value: 0.949Mixed Models Analysis
p-value: 1Mixed Models Analysis
p-value: 0.268Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation
Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 12 Week Change | -0.32 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.56 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.26 units on a scale | Standard Error 0.2 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 12 Week Change | -0.36 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 12 Week Change | -0.45 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.77 units on a scale | Standard Error 0.13 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 12 Week Change | -0.13 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.70 units on a scale | Standard Error 0.25 |
p-value: 0.682Mixed Models Analysis
p-value: 0.001Mixed Models Analysis
p-value: 0.2Mixed Models Analysis
p-value: 0.813Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity
Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 12 Week Change | -0.43 units on a scale | Standard Error 0.04 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 9 Month Change (n=29, n=8, n=32, n=10) | -0.60 units on a scale | Standard Error 0.07 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 9 Month Change (n=29, n=8, n=32, n=10) | -0.54 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 12 Week Change | -0.49 units on a scale | Standard Error 0.07 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 12 Week Change | -0.42 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 9 Month Change (n=29, n=8, n=32, n=10) | -0.63 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 12 Week Change | -0.21 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity | 9 Month Change (n=29, n=8, n=32, n=10) | -0.56 units on a scale | Standard Error 0.14 |
p-value: 0.438Mixed Models Analysis
p-value: 0.018Mixed Models Analysis
p-value: 0.692Mixed Models Analysis
p-value: 0.668Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization
Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 12 Week Change | -0.19 units on a scale | Standard Error 0.02 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 9 Month Change (n=29, n=9, n=33, n=10) | -0.60 units on a scale | Standard Error 0.07 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 9 Month Change (n=29, n=9, n=33, n=10) | -0.54 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 12 Week Change | -0.21 units on a scale | Standard Error 0.03 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 12 Week Change | -0.15 units on a scale | Standard Error 0.02 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 9 Month Change (n=29, n=9, n=33, n=10) | -0.63 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 12 Week Change | -0.14 units on a scale | Standard Error 0.03 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization | 9 Month Change (n=29, n=9, n=33, n=10) | -0.56 units on a scale | Standard Error 0.14 |
p-value: 0.588Mixed Models Analysis
p-value: 0.758Mixed Models Analysis
p-value: 0.692Mixed Models Analysis
p-value: 0.668Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms
Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 12 Week Change | -0.15 units on a scale | Standard Error 0.02 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.60 units on a scale | Standard Error 0.07 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.54 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 12 Week Change | -0.12 units on a scale | Standard Error 0.04 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 12 Week Change | -0.13 units on a scale | Standard Error 0.02 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.63 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 12 Week Change | -0.11 units on a scale | Standard Error 0.03 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.56 units on a scale | Standard Error 0.14 |
p-value: 0.507Mixed Models Analysis
p-value: 0.466Mixed Models Analysis
p-value: 0.692Mixed Models Analysis
p-value: 0.668Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms
Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.60 units on a scale | Standard Error 0.07 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 12 Week Change | -0.08 units on a scale | Standard Error 0.02 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.54 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 12 Week Change | -0.06 units on a scale | Standard Error 0.03 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 12 Week Change | -0.04 units on a scale | Standard Error 0.02 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.63 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 12 Week Change | -0.06 units on a scale | Standard Error 0.03 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms | 9 Month Change (n=29, n=9, n=33, n=10) | -0.56 units on a scale | Standard Error 0.14 |
p-value: 0.487Mixed Models Analysis
p-value: 0.678Mixed Models Analysis
p-value: 0.692Mixed Models Analysis
p-value: 0.668Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness
Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 12 Week Change | -0.95 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.16 units on a scale | Standard Error 0.09 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 9 Month Change (n=29, n=9, n=33, n=10) | -0.90 units on a scale | Standard Error 0.16 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 12 Week Change | -0.88 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 12 Week Change | -0.98 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.34 units on a scale | Standard Error 9.63 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 12 Week Change | -0.81 units on a scale | Standard Error 0.1 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.24 units on a scale | Standard Error 17.77 |
p-value: 0.505Mixed Models Analysis
p-value: 0.135Mixed Models Analysis
p-value: 0.175Mixed Models Analysis
p-value: 1Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness
Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 12 Week Change | -0.87 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.23 units on a scale | Standard Error 0.08 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.34 units on a scale | Standard Error 0.15 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 12 Week Change | -0.74 units on a scale | Standard Error 0.08 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 12 Week Change | -0.80 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 9 Month Change (n=29, n=9, n=33, n=10) | -0.92 units on a scale | Standard Error 0.07 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 12 Week Change | -0.51 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness | 9 Month Change (n=29, n=9, n=33, n=10) | -0.85 units on a scale | Standard Error 0.14 |
p-value: 0.175Mixed Models Analysis
p-value: 0.002Mixed Models Analysis
p-value: 0.576Mixed Models Analysis
p-value: 0.676Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness
Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 12 Week Change | -1.00 units on a scale | Standard Error 0.06 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.23 units on a scale | Standard Error 0.08 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 9 Month Change (n=29, n=9, n=33, n=10) | -1.34 units on a scale | Standard Error 0.15 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 12 Week Change | -0.95 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 12 Week Change | -0.95 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 9 Month Change (n=29, n=9, n=33, n=10) | -0.92 units on a scale | Standard Error 0.07 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 12 Week Change | -0.79 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness | 9 Month Change (n=29, n=9, n=33, n=10) | -0.85 units on a scale | Standard Error 0.14 |
p-value: 0.675Mixed Models Analysis
p-value: 0.139Mixed Models Analysis
p-value: 0.576Mixed Models Analysis
p-value: 0.676Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt
Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 12 Week Change | -1.19 units on a scale | Standard Error 0.06 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 9 Month Change (n=29, n=9, n=33, n=10) | -1.32 units on a scale | Standard Error 0.1 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 9 Month Change (n=29, n=9, n=33, n=10) | -1.21 units on a scale | Standard Error 0.17 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 12 Week Change | -1.06 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 12 Week Change | -1.15 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 9 Month Change (n=29, n=9, n=33, n=10) | -1.37 units on a scale | Standard Error 0.06 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 12 Week Change | -0.89 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt | 9 Month Change (n=29, n=9, n=33, n=10) | -1.16 units on a scale | Standard Error 0.13 |
p-value: 0.204Mixed Models Analysis
p-value: 0.011Mixed Models Analysis
p-value: 0.571Mixed Models Analysis
p-value: 0.133Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide
Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).
Time frame: Baseline, 12 weeks, 9 Months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 12 Week Change | -0.46 units on a scale | Standard Error 0.04 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 9 Month Change (n=29, n= 9, n=33, n=10) | -1.32 units on a scale | Standard Error 0.1 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 9 Month Change (n=29, n= 9, n=33, n=10) | -1.21 units on a scale | Standard Error 0.17 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 12 Week Change | -0.30 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 12 Week Change | -0.40 units on a scale | Standard Error 0.04 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 9 Month Change (n=29, n= 9, n=33, n=10) | -1.37 units on a scale | Standard Error 0.06 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 12 Week Change | -0.29 units on a scale | Standard Error 0.06 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide | 9 Month Change (n=29, n= 9, n=33, n=10) | -1.16 units on a scale | Standard Error 0.13 |
p-value: 0.023Mixed Models Analysis
p-value: 0.1Mixed Models Analysis
p-value: 0.571Mixed Models Analysis
p-value: 0.133Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early
Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 12 Week Change | -0.72 units on a scale | Standard Error 0.06 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 9 Month Change (n=29, n=9, n=33, n=10) | -0.85 units on a scale | Standard Error 0.13 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 9 Month Change (n=29, n=9, n=33, n=10) | -0.77 units on a scale | Standard Error 0.23 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 12 Week Change | -0.61 units on a scale | Standard Error 0.1 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 12 Week Change | -0.68 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 9 Month Change (n=29, n=9, n=33, n=10) | -0.71 units on a scale | Standard Error 0.13 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 12 Week Change | -0.46 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early | 9 Month Change (n=29, n=9, n=33, n=10) | -0.86 units on a scale | Standard Error 0.24 |
p-value: 0.332Mixed Models Analysis
p-value: 0.041Mixed Models Analysis
p-value: 0.775Mixed Models Analysis
p-value: 0.588Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle
Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 12 Week Change | -0.69 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 9 Month Change (n=29, n=9, n=33, n=10) | -0.99 units on a scale | Standard Error 0.11 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 9 Month Change (n=29, n=9, n=33, n=10) | -0.92 units on a scale | Standard Error 0.19 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 12 Week Change | -0.74 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 12 Week Change | -0.66 units on a scale | Standard Error 0.06 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 9 Month Change (n=29, n=9, n=33, n=10) | -0.99 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 12 Week Change | -0.59 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle | 9 Month Change (n=29, n=9, n=33, n=10) | -0.67 units on a scale | Standard Error 0.16 |
p-value: 0.624Mixed Models Analysis
p-value: 0.473Mixed Models Analysis
p-value: 0.787Mixed Models Analysis
p-value: 0.086Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late
Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 12 Week Change | -0.66 units on a scale | Standard Error 0.05 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 9 Month Change (n=29, n=9, n=33, n=10) | -0.94 units on a scale | Standard Error 0.05 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 9 Month Change (n=29, n=9, n=33, n=10) | -0.87 units on a scale | Standard Error 0.08 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 12 Week Change | -0.49 units on a scale | Standard Error 0.09 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 12 Week Change | -0.57 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 9 Month Change (n=29, n=9, n=33, n=10) | -0.78 units on a scale | Standard Error 0.1 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 12 Week Change | -0.45 units on a scale | Standard Error 0.08 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late | 9 Month Change (n=29, n=9, n=33, n=10) | -0.52 units on a scale | Standard Error 0.19 |
p-value: 0.099Mixed Models Analysis
p-value: 0.223Mixed Models Analysis
p-value: 0.473Mixed Models Analysis
p-value: 0.233Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation
Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 12 Week Change | -0.72 units on a scale | Standard Error 0.04 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.89 units on a scale | Standard Error 0.05 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.90 units on a scale | Standard Error 0.09 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 12 Week Change | -0.69 units on a scale | Standard Error 0.07 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 12 Week Change | -0.66 units on a scale | Standard Error 0.04 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 9 Month Change (n=29, n=9, n=33, n=10) | -1.66 units on a scale | Standard Error 0.13 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 12 Week Change | -0.51 units on a scale | Standard Error 0.07 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation | 9 Month Change (n=29, n=9, n=33, n=10) | -1.50 units on a scale | Standard Error 0.25 |
p-value: 0.67Mixed Models Analysis
p-value: 0.059Mixed Models Analysis
p-value: 0.93Mixed Models Analysis
p-value: 0.567Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation
Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 12 Week Change | -0.47 units on a scale | Standard Error 0.04 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.53 units on a scale | Standard Error 0.07 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.61 units on a scale | Standard Error 0.12 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 12 Week Change | -0.48 units on a scale | Standard Error 0.07 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 12 Week Change | -0.44 units on a scale | Standard Error 0.05 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.57 units on a scale | Standard Error 0.11 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 12 Week Change | -0.41 units on a scale | Standard Error 0.09 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation | 9 Month Change (n=29, n=9, n=33, n=10) | -0.78 units on a scale | Standard Error 0.21 |
p-value: 0.896Mixed Models Analysis
p-value: 0.796Mixed Models Analysis
p-value: 0.571Mixed Models Analysis
p-value: 0.381Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)
Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 12 Week Change | -1.14 units on a scale | Standard Deviation 0.16 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 12 Week Change | -1.33 units on a scale | Standard Deviation 0.17 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 9 Month Change (n=29, n=9, n=33, n=10) | -1.30 units on a scale | Standard Deviation 0.41 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 9 Month Change (n=29, n=9, n=33, n=10) | -1.56 units on a scale | Standard Deviation 0.42 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 12 Week Change | -1.73 units on a scale | Standard Deviation 0.27 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 9 Month Change (n=29, n=9, n=33, n=10) | -0.10 units on a scale | Standard Deviation 0.73 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 9 Month Change (n=29, n=9, n=33, n=10) | -0.42 units on a scale | Standard Deviation 0.74 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 12 Week Change | -1.35 units on a scale | Standard Deviation 0.26 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 9 Month Change (n=29, n=9, n=33, n=10) | -2.10 units on a scale | Standard Deviation 0.41 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 12 Week Change | -1.14 units on a scale | Standard Deviation 0.18 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 9 Month Change (n=29, n=9, n=33, n=10) | -2.24 units on a scale | Standard Deviation 0.35 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 12 Week Change | -0.96 units on a scale | Standard Deviation 0.18 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 9 Month Change (n=29, n=9, n=33, n=10) | -2.11 units on a scale | Standard Deviation 0.64 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 7 - 12 Week Change | -1.36 units on a scale | Standard Deviation 0.3 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 12 Week Change | -1.16 units on a scale | Standard Deviation 0.3 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS) | Item 1 - 9 Month Change (n=29, n=9, n=33, n=10) | -2.36 units on a scale | Standard Deviation 0.75 |
p-value: 0.475Mixed Models Analysis
p-value: 0.561Mixed Models Analysis
p-value: 0.213Mixed Models Analysis
p-value: 0.536Mixed Models Analysis
p-value: 0.158Mixed Models Analysis
p-value: 0.759Mixed Models Analysis
p-value: 0.19Mixed Models Analysis
p-value: 0.852Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 12 Week Change | 1.40 beats per minute | Standard Error 0.57 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 9 Month Change (n=28, n=9, n=33, n=10) | 1.08 beats per minute | Standard Error 1.79 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 9 Month Change (n=28, n=9, n=33, n=10) | -0.30 beats per minute | Standard Error 3.11 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 12 Week Change | -1.52 beats per minute | Standard Error 1.01 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 12 Week Change | 0.68 beats per minute | Standard Error 0.7 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 9 Month Change (n=28, n=9, n=33, n=10) | 1.18 beats per minute | Standard Error 1.17 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 12 Week Change | -2.05 beats per minute | Standard Error 1.18 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate | 9 Month Change (n=28, n=9, n=33, n=10) | -3.04 beats per minute | Standard Error 2.05 |
p-value: 0.012Mixed Models Analysis
p-value: 0.045Mixed Models Analysis
p-value: 0.701Mixed Models Analysis
p-value: 0.081Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)
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). Please see baseline demographics for subscale total scores.
Time frame: Baseline, 8 weeks, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 12 Week Change (n=194,n=59,n=195,n=64) | -12.64 units on a scale | Standard Error 0.5 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 12 Week Change (n=194,n=59,n=195,n=64) | -7.38 units on a scale | Standard Error 0.29 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 9 Month Change (n=29,n=9,n=33,n=10) | -4.09 units on a scale | Standard Error 0.3 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Maier 8 Week Change (n=214,n=102,n=220,n=110) | -6.11 units on a scale | Standard Error 0.27 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 9 Month Change (n=29,n=9,n=33,n=10) | -14.38 units on a scale | Standard Error 1.02 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 12 Week Change (n=194,n=59,n=195,n=64) | -4.72 units on a scale | Standard Error 0.19 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 12 Week Change (n=194,n=59,n=195,n=64) | -3.52 units on a scale | Standard Error 0.16 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 9 Month Change (n=29,n=9,n=33,n=10) | -2.77 units on a scale | Standard Error 0.23 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 9 Month Change (n=29,n=9,n=33,n=10) | -5.35 units on a scale | Standard Error 0.4 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 12 Week Change (n=194,n=59,n=195,n=64) | -2.08 units on a scale | Standard Error 0.13 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 9 Month Change (n=29,n=9,n=33,n=10) | -8.56 units on a scale | Standard Error 0.58 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 12 Week Change (n=194,n=59,n=195,n=64) | -1.72 units on a scale | Standard Error 0.22 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 9 Month Change (n=29,n=9,n=33,n=10) | -8.02 units on a scale | Standard Error 1.04 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 9 Month Change (n=29,n=9,n=33,n=10) | -13.38 units on a scale | Standard Error 1.86 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 9 Month Change (n=29,n=9,n=33,n=10) | -3.88 units on a scale | Standard Error 0.56 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 12 Week Change (n=194,n=59,n=195,n=64) | -3.12 units on a scale | Standard Error 0.27 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 9 Month Change (n=29,n=9,n=33,n=10) | -2.56 units on a scale | Standard Error 0.4 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 12 Week Change (n=194,n=59,n=195,n=64) | -6.17 units on a scale | Standard Error 0.47 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 9 Month Change (n=29,n=9,n=33,n=10) | -5.83 units on a scale | Standard Error 0.72 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 12 Week Change (n=194,n=59,n=195,n=64) | -4.06 units on a scale | Standard Error 0.32 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Maier 8 Week Change (n=214,n=102,n=220,n=110) | -4.69 units on a scale | Standard Error 0.38 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 12 Week Change (n=194,n=59,n=195,n=64) | -10.33 units on a scale | Standard Error 0.79 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 9 Month Change (n=29,n=9,n=33,n=10) | -3.68 units on a scale | Standard Error 0.44 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 12 Week Change (n=194,n=59,n=195,n=64) | -12.11 units on a scale | Standard Error 0.47 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Maier 8 Week Change (n=214,n=102,n=220,n=110) | -6.13 units on a scale | Standard Error 0.24 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 12 Week Change (n=194,n=59,n=195,n=64) | -3.52 units on a scale | Standard Error 0.17 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 12 Week Change (n=194,n=59,n=195,n=64) | -6.98 units on a scale | Standard Error 0.27 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 12 Week Change (n=194,n=59,n=195,n=64) | -4.49 units on a scale | Standard Error 0.19 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 12 Week Change (n=194,n=59,n=195,n=64) | -1.91 units on a scale | Standard Error 0.12 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 9 Month Change (n=29,n=9,n=33,n=10) | -9.56 units on a scale | Standard Error 1.26 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 9 Month Change (n=29,n=9,n=33,n=10) | -3.44 units on a scale | Standard Error 0.35 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 9 Month Change (n=29,n=9,n=33,n=10) | -5.80 units on a scale | Standard Error 0.7 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 9 Month Change (n=29,n=9,n=33,n=10) | -2.55 units on a scale | Standard Error 0.26 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 12 Week Change (n=194,n=59,n=195,n=64) | -1.48 units on a scale | Standard Error 0.2 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Sleep 9 Month Change (n=29,n=9,n=33,n=10) | -1.95 units on a scale | Standard Error 0.48 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 9 Month Change (n=29,n=9,n=33,n=10) | -4.35 units on a scale | Standard Error 1.3 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 12 Week Change (n=194,n=59,n=195,n=64) | -3.05 units on a scale | Standard Error 0.31 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Bech 12 Week Change (n=194,n=59,n=195,n=64) | -4.70 units on a scale | Standard Error 0.43 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 12 Week Change (n=194,n=59,n=195,n=64) | -2.44 units on a scale | Standard Error 0.27 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Retardation 9 Month Change (n=29,n=9,n=33,n=10) | -2.52 units on a scale | Standard Error 0.81 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Maier 8 Week Change (n=214,n=102,n=220,n=110) | -4.45 units on a scale | Standard Error 0.33 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 12 Week Change (n=194,n=59,n=195,n=64) | -8.48 units on a scale | Standard Error 0.75 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Anxiety 9 Month Change (n=29,n=9,n=33,n=10) | -2.77 units on a scale | Standard Error 0.65 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale) | Total Score 9 Month Change (n=29,n=9,n=33,n=10) | -5.92 units on a scale | Standard Error 2.32 |
p-value: 0.013Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.026Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.202Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.027Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.076Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.149Mixed Models Analysis
p-value: 0.062Mixed Models Analysis
p-value: 0.629Mixed Models Analysis
p-value: 0.194Mixed Models Analysis
p-value: 0.525Mixed Models Analysis
p-value: 0.595Mixed Models Analysis
p-value: 0.736Mixed Models Analysis
p-value: 0.368Mixed Models Analysis
p-value: 0.66Mixed Models Analysis
p-value: 0.334Mixed Models Analysis
p-value: 0.568Mixed Models Analysis
p-value: 0.216Mixed Models Analysis
p-value: 0.646Mixed Models Analysis
p-value: 0.275Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood
Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 12 Week Change | -1.86 units on a scale | Standard Error 0.07 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 9 Month Change (n=29, n=9, n=33, n=10) | -1.44 units on a scale | Standard Error 0.2 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 9 Month Change (n=29, n=9, n=33, n=10) | -1.26 units on a scale | Standard Error 0.34 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 12 Week Change | -1.52 units on a scale | Standard Error 0.12 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 12 Week Change | -1.78 units on a scale | Standard Error 0.07 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 9 Month Change (n=29, n=9, n=33, n=10) | -1.98 units on a scale | Standard Error 0.19 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 12 Week Change | -1.15 units on a scale | Standard Error 0.12 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood | 9 Month Change (n=29, n=9, n=33, n=10) | -1.65 units on a scale | Standard Error 0.35 |
p-value: 0.016Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.653Mixed Models Analysis
p-value: 0.417Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 12 Week Change | -16.24 units on a scale | Standard Error 0.62 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 9 Month Change (n=29, n=8, n=32, n=10) | -17.05 units on a scale | Standard Error 1.15 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 9 Month Change (n=29, n=8, n=32, n=10) | -15.22 units on a scale | Standard Error 2.14 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 12 Week Change | -13.24 units on a scale | Standard Error 1.01 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 12 Week Change | -15.60 units on a scale | Standard Error 0.61 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 9 Month Change (n=29, n=8, n=32, n=10) | -13.49 units on a scale | Standard Error 1.45 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 12 Week Change | -10.94 units on a scale | Standard Error 0.96 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score | 9 Month Change (n=29, n=8, n=32, n=10) | -9.12 units on a scale | Standard Error 2.64 |
p-value: 0.011Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: 0.449Mixed Models Analysis
p-value: 0.167Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)
A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 12 Week Change | -7.60 units on a scale | Standard Error 0.46 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 9 Month Change (n=29, n=9, n=32, n=10) | -7.17 units on a scale | Standard Error 0.88 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 9 Month Change (n=29, n=9, n=32, n=10) | -7.13 units on a scale | Standard Error 1.54 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 12 Week Change | -6.39 units on a scale | Standard Error 0.74 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 12 Week Change | -7.96 units on a scale | Standard Error 0.47 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 9 Month Change (n=29, n=9, n=32, n=10) | -8.19 units on a scale | Standard Error 0.84 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 12 Week Change | -6.85 units on a scale | Standard Error 0.74 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) | 9 Month Change (n=29, n=9, n=32, n=10) | -6.77 units on a scale | Standard Error 1.48 |
p-value: 0.161Mixed Models Analysis
p-value: 0.198Mixed Models Analysis
p-value: 0.982Mixed Models Analysis
p-value: 0.407Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score
A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 12 Week Change | 7.18 units on a scale | Standard Error 0.62 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 9 Month Change (n=28, n=9, n=30, n=10) | 8.00 units on a scale | Standard Error 1.14 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 9 Month Change (n=28, n=9, n=30, n=10) | 5.30 units on a scale | Standard Error 1.92 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 12 Week Change | 3.40 units on a scale | Standard Error 0.99 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 12 Week Change | 7.54 units on a scale | Standard Error 0.61 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 9 Month Change (n=28, n=9, n=30, n=10) | 13.81 units on a scale | Standard Error 1.04 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 12 Week Change | 4.52 units on a scale | Standard Error 0.92 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score | 9 Month Change (n=28, n=9, n=30, n=10) | 9.28 units on a scale | Standard Error 1.92 |
p-value: 0.001Mixed Models Analysis
p-value: 0.006Mixed Models Analysis
p-value: 0.231Mixed Models Analysis
p-value: 0.04Mixed Models Analysis
Secondary
Change From Baseline to 12 Week and 9 Month Endpoints in Weight
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 12 Week Change | -0.54 kilograms | Standard Error 0.2 |
| Group A - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 9 Month Change (n=28, n=9, n=33, n=10) | -1.18 kilograms | Standard Error 2.31 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 9 Month Change (n=28, n=9, n=33, n=10) | -0.44 kilograms | Standard Error 4.02 |
| Group A - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 12 Week Change | 0.38 kilograms | Standard Error 0.31 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 12 Week Change | -0.38 kilograms | Standard Error 0.2 |
| Group B - Duloxetine | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 9 Month Change (n=28, n=9, n=33, n=10) | -0.94 kilograms | Standard Error 0.55 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 12 Week Change | -0.23 kilograms | Standard Error 0.3 |
| Group B - Placebo | Change From Baseline to 12 Week and 9 Month Endpoints in Weight | 9 Month Change (n=28, n=9, n=33, n=10) | 0.06 kilograms | Standard Error 1.02 |
p-value: 0.013Mixed Models Analysis
p-value: 0.672Mixed Models Analysis
p-value: 0.874Mixed Models Analysis
p-value: 0.39Mixed Models Analysis
Secondary
Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).
Time frame: Baseline, 12 weeks
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Total Score (n=192,n=54,n=185,n=61) | -26.41 units on a scale | Standard Error 1.44 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Fatigue-Inertia (n=193,n=57,n=190,n=63) | -5.30 units on a scale | Standard Error 0.36 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Vigor-Activity (n=192,n=55,192,n=63) | 2.55 units on a scale | Standard Error 0.29 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Tension-Anxiety (n=193,n=58,n=193,n=62) | -4.37 units on a scale | Standard Error 0.26 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Confusion-Bewilderment (n=192,n=58,n=189,n=62) | -3.62 units on a scale | Standard Error 0.23 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Depression-Dejection (n=193,n=58,n=191,n=62) | -6.30 units on a scale | Standard Error 0.33 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Anger-Hostility (n=193,n=58,n=192,n=63) | -4.46 units on a scale | Standard Error 0.28 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Fatigue-Inertia (n=193,n=57,n=190,n=63) | -4.68 units on a scale | Standard Error 0.59 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Anger-Hostility (n=193,n=58,n=192,n=63) | -3.09 units on a scale | Standard Error 0.46 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Depression-Dejection (n=193,n=58,n=191,n=62) | -4.64 units on a scale | Standard Error 0.55 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Vigor-Activity (n=192,n=55,192,n=63) | 1.82 units on a scale | Standard Error 0.49 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Confusion-Bewilderment (n=192,n=58,n=189,n=62) | -2.86 units on a scale | Standard Error 0.39 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Tension-Anxiety (n=193,n=58,n=193,n=62) | -3.20 units on a scale | Standard Error 0.44 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Total Score (n=192,n=54,n=185,n=61) | -18.88 units on a scale | Standard Error 2.38 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Anger-Hostility (n=193,n=58,n=192,n=63) | -4.94 units on a scale | Standard Error 0.3 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Total Score (n=192,n=54,n=185,n=61) | -28.67 units on a scale | Standard Error 1.52 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Tension-Anxiety (n=193,n=58,n=193,n=62) | -4.61 units on a scale | Standard Error 0.3 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Depression-Dejection (n=193,n=58,n=191,n=62) | -6.78 units on a scale | Standard Error 0.34 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Vigor-Activity (n=192,n=55,192,n=63) | 2.57 units on a scale | Standard Error 0.32 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Fatigue-Inertia (n=193,n=57,n=190,n=63) | -6.08 units on a scale | Standard Error 0.37 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Confusion-Bewilderment (n=192,n=58,n=189,n=62) | -3.56 units on a scale | Standard Error 0.25 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Depression-Dejection (n=193,n=58,n=191,n=62) | -5.03 units on a scale | Standard Error 0.53 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Confusion-Bewilderment (n=192,n=58,n=189,n=62) | -3.10 units on a scale | Standard Error 0.4 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Fatigue-Inertia (n=193,n=57,n=190,n=63) | -5.54 units on a scale | Standard Error 0.59 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Tension-Anxiety (n=193,n=58,n=193,n=62) | -4.05 units on a scale | Standard Error 0.49 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Total Score (n=192,n=54,n=185,n=61) | -22.67 units on a scale | Standard Error 2.37 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Vigor-Activity (n=192,n=55,192,n=63) | 1.48 units on a scale | Standard Error 0.51 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment). | Anger-Hostility (n=193,n=58,n=192,n=63) | -3.63 units on a scale | Standard Error 0.48 |
p-value: 0.007Mixed Models Analysis
p-value: 0.031Mixed Models Analysis
p-value: 0.02Mixed Models Analysis
p-value: 0.324Mixed Models Analysis
p-value: 0.01Mixed Models Analysis
p-value: 0.005Mixed Models Analysis
p-value: 0.01Mixed Models Analysis
p-value: 0.019Mixed Models Analysis
p-value: 0.201Mixed Models Analysis
p-value: 0.069Mixed Models Analysis
p-value: 0.368Mixed Models Analysis
p-value: 0.435Mixed Models Analysis
p-value: 0.09Mixed Models Analysis
p-value: 0.313Mixed Models Analysis
Secondary
Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores
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. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.
Time frame: Baseline, 12 weeks
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=133,n=43,n=140,n=49) | -2.47 units on a scale | Standard Error 0.22 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=194,n=59,n=195,n=63) | -2.93 units on a scale | Standard Error 0.19 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=194,n=59,n=195,n=63) | -2.81 units on a scale | Standard Error 0.19 |
| Group A - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=195,n=59,n=195,n=63) | -8.32 units on a scale | Standard Error 0.53 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=194,n=59,n=195,n=63) | -2.50 units on a scale | Standard Error 0.31 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=194,n=59,n=195,n=63) | -2.19 units on a scale | Standard Error 0.32 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=195,n=59,n=195,n=63) | -6.84 units on a scale | Standard Error 0.87 |
| Group A - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=133,n=43,n=140,n=49) | -2.12 units on a scale | Standard Error 0.34 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=194,n=59,n=195,n=63) | -2.66 units on a scale | Standard Error 0.19 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=194,n=59,n=195,n=63) | -2.67 units on a scale | Standard Error 0.19 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=195,n=59,n=195,n=63) | -7.70 units on a scale | Standard Error 0.52 |
| Group B - Duloxetine | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=133,n=43,n=140,n=49) | -1.98 units on a scale | Standard Error 0.22 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=195,n=59,n=195,n=63) | -4.94 units on a scale | Standard Error 0.84 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=194,n=59,n=195,n=63) | -1.97 units on a scale | Standard Error 0.3 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=133,n=43,n=140,n=49) | -1.22 units on a scale | Standard Error 0.36 |
| Group B - Placebo | Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=194,n=59,n=195,n=63) | -1.56 units on a scale | Standard Error 0.31 |
p-value: 0.229Mixed Models Analysis
p-value: 0.044Mixed Models Analysis
p-value: 0.092Mixed Models Analysis
p-value: 0.002Mixed Models Analysis
p-value: 0.366Mixed Models Analysis
p-value: 0.065Mixed Models Analysis
p-value: 0.142Mixed Models Analysis
p-value: 0.005Mixed Models Analysis
Secondary
Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)
The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).
Time frame: Baseline, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Total Score | -25.67 units on a scale | Standard Error 2.83 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Fatigue-Inertia | -7.43 units on a scale | Standard Error 0.73 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Vigor-Activity | 2.63 units on a scale | Standard Error 0.78 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Tension-Anxiety | -5.36 units on a scale | Standard Error 0.51 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Confusion-Bewilderment | -3.95 units on a scale | Standard Error 0.45 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Depression-Dejection | -7.60 units on a scale | Standard Error 0.6 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Anger-Hostility | -4.34 units on a scale | Standard Error 0.6 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Fatigue-Inertia | -7.40 units on a scale | Standard Error 1.26 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Anger-Hostility | -3.38 units on a scale | Standard Error 1.04 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Depression-Dejection | -6.49 units on a scale | Standard Error 1.04 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Vigor-Activity | 3.11 units on a scale | Standard Error 1.39 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Confusion-Bewilderment | -2.47 units on a scale | Standard Error 0.79 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Tension-Anxiety | -4.18 units on a scale | Standard Error 0.88 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Total Score | -22.99 units on a scale | Standard Error 4.89 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Anger-Hostility | -5.98 units on a scale | Standard Error 0.4 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Total Score | -28.39 units on a scale | Standard Error 2.46 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Tension-Anxiety | -4.68 units on a scale | Standard Error 0.5 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Depression-Dejection | -7.18 units on a scale | Standard Error 0.63 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Vigor-Activity | 2.00 units on a scale | Standard Error 0.74 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Fatigue-Inertia | -6.34 units on a scale | Standard Error 0.59 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Confusion-Bewilderment | -3.54 units on a scale | Standard Error 0.35 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Depression-Dejection | -5.56 units on a scale | Standard Error 1.24 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Confusion-Bewilderment | -3.07 units on a scale | Standard Error 0.64 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Fatigue-Inertia | -7.03 units on a scale | Standard Error 1.17 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Tension-Anxiety | -3.50 units on a scale | Standard Error 0.94 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Total Score | -25.51 units on a scale | Standard Error 4.68 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Vigor-Activity | 3.04 units on a scale | Standard Error 1.42 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment) | Anger-Hostility | -4.99 units on a scale | Standard Error 0.73 |
p-value: 0.639Mixed Models Analysis
p-value: 0.584Mixed Models Analysis
p-value: 0.251Mixed Models Analysis
p-value: 0.265Mixed Models Analysis
p-value: 0.366Mixed Models Analysis
p-value: 0.257Mixed Models Analysis
p-value: 0.426Mixed Models Analysis
p-value: 0.234Mixed Models Analysis
p-value: 0.765Mixed Models Analysis
p-value: 0.522Mixed Models Analysis
p-value: 0.986Mixed Models Analysis
p-value: 0.602Mixed Models Analysis
p-value: 0.11Mixed Models Analysis
p-value: 0.505Mixed Models Analysis
Secondary
Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities
Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
Time frame: Baseline, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities | -2.43 units on a scale | Standard Error 0.1 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities | -2.55 units on a scale | Standard Error 0.19 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities | -1.66 units on a scale | Standard Error 0.13 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities | -1.50 units on a scale | Standard Error 0.25 |
p-value: 0.577Mixed Models Analysis
p-value: 0.567Mixed Models Analysis
Secondary
Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores
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. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.
Time frame: Baseline, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=22, n=8, n=22, n=7) | -3.88 units on a scale | Standard Error 0.69 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=29, n=9, n=33, n=10) | -4.15 units on a scale | Standard Error 0.37 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=29, n=9, n=33, n=10) | -3.46 units on a scale | Standard Error 0.36 |
| Group A - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=29, n=9, n=33, n=10) | -11.60 units on a scale | Standard Error 1.02 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=29, n=9, n=33, n=10) | -4.35 units on a scale | Standard Error 0.65 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=29, n=9, n=33, n=10) | -2.99 units on a scale | Standard Error 0.64 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=29, n=9, n=33, n=10) | -11.15 units on a scale | Standard Error 1.79 |
| Group A - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=22, n=8, n=22, n=7) | -4.01 units on a scale | Standard Error 1.1 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=29, n=9, n=33, n=10) | -3.30 units on a scale | Standard Error 0.34 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=29, n=9, n=33, n=10) | -3.88 units on a scale | Standard Error 0.33 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=29, n=9, n=33, n=10) | -9.42 units on a scale | Standard Error 0.97 |
| Group B - Duloxetine | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=22, n=8, n=22, n=7) | -2.26 units on a scale | Standard Error 0.37 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Total Score (n=29, n=9, n=33, n=10) | -8.67 units on a scale | Standard Error 1.88 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Social Life (n=29, n=9, n=33, n=10) | -3.66 units on a scale | Standard Error 0.62 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Work Life (n=22, n=8, n=22, n=7) | -2.16 units on a scale | Standard Error 0.66 |
| Group B - Placebo | Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores | Family Life (n=29, n=9, n=33, n=10) | -3.07 units on a scale | Standard Error 0.66 |
p-value: 0.921Mixed Models Analysis
p-value: 0.895Mixed Models Analysis
p-value: 0.789Mixed Models Analysis
p-value: 0.761Mixed Models Analysis
p-value: 0.519Mixed Models Analysis
p-value: 0.755Mixed Models Analysis
p-value: 0.829Mixed Models Analysis
p-value: 0.723Mixed Models Analysis
Secondary
Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7
Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.
Time frame: Over 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Direct Treatment Effect | -0.032 coefficient |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Total Treatment Effect | 0.343 coefficient |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Indirect Treatment Effect from BPOMS Total Score | 0.376 coefficient |
| Group A - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Direct Treatment Effect | -0.012 coefficient |
| Group A - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Total Treatment Effect | 0.132 coefficient |
| Group A - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Indirect Treatment Effect from BPOMS Total Score | 0.145 coefficient |
| Group B - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Indirect Treatment Effect from BPOMS Total Score | 0.209 coefficient |
| Group B - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Direct Treatment Effect | 0.219 coefficient |
| Group B - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Total Treatment Effect | 0.428 coefficient |
| Group B - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Direct Treatment Effect | 0.087 coefficient |
| Group B - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Total Treatment Effect | 0.170 coefficient |
| Group B - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 | Indirect Treatment Effect from BPOMS Total Score | 0.083 coefficient |
p-value: 0.753Regression, Linear
p-value: 0.036Regression, Linear
Secondary
Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect
For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.
Time frame: over 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect | Direct Treatment Effect | 51.14 percent of total effect |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect | Indirect Treatment Effect from BPOMS Total Score | 48.86 percent of total effect |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect | Total Treatment Effect | 100.00 percent of total effect |
Secondary
Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect
For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.
Time frame: Over 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect | Direct Treatment Effect | 35.17 percent of total effect |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect | Indirect Treatment Effect from BPOMS Total Score | 64.83 percent of total effect |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect | Total Treatment Effect | 100.00 percent of total effect |
Secondary
Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score
Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.
Time frame: over 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Total Treatment Effect | 2.177 coefficient |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Direct Treatment Effect | -0.577 coefficient |
| Group A - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Indirect Treatment Effect from BPOMS Total Score | 2.754 coefficient |
| Group A - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Indirect Treatment Effect from BPOMS Total Score | 0.151 coefficient |
| Group A - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Direct Treatment Effect | -0.032 coefficient |
| Group A - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Total Treatment Effect | 0.120 coefficient |
| Group B - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Indirect Treatment Effect from BPOMS Total Score | 1.761 coefficient |
| Group B - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Direct Treatment Effect | 0.955 coefficient |
| Group B - Duloxetine | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Total Treatment Effect | 2.716 coefficient |
| Group B - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Direct Treatment Effect | 0.052 coefficient |
| Group B - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Total Treatment Effect | 0.147 coefficient |
| Group B - Placebo | Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score | Indirect Treatment Effect from BPOMS Total Score | 0.095 coefficient |
p-value: 0.342Regression, Linear
p-value: 0.111Regression, Linear
Secondary
Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint
Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.
Time frame: 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week HAMD-17 Total (n=194,n=59,n=195,n=64) | 0.38 probability of remission | Standard Error 0.21 |
| Group A - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.30 probability of remission | Standard Error 0.19 |
| Group A - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month HAMD-17 Total Score (n=29,n=9,n=33,n=10) | 0.63 probability of remission | Standard Error 0.35 |
| Group A - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month QIDS16 Total Score (n=29,n=9,n=33,n=9) | 0.71 probability of remission | Standard Error 0.31 |
| Group A - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.30 probability of remission | Standard Error 0.3 |
| Group A - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month HAMD-17 Total Score (n=29,n=9,n=33,n=10) | 0.62 probability of remission | Standard Error 0.63 |
| Group A - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month QIDS16 Total Score (n=29,n=9,n=33,n=9) | 0.54 probability of remission | Standard Error 0.51 |
| Group A - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week HAMD-17 Total (n=194,n=59,n=195,n=64) | 0.35 probability of remission | Standard Error 0.31 |
| Group B - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month HAMD-17 Total Score (n=29,n=9,n=33,n=10) | 0.70 probability of remission | Standard Error 0.36 |
| Group B - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.33 probability of remission | Standard Error 0.17 |
| Group B - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month QIDS16 Total Score (n=29,n=9,n=33,n=9) | 0.71 probability of remission | Standard Error 0.35 |
| Group B - Duloxetine | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week HAMD-17 Total (n=194,n=59,n=195,n=64) | 0.35 probability of remission | Standard Error 0.19 |
| Group B - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month QIDS16 Total Score (n=29,n=9,n=33,n=9) | 0.64 probability of remission | Standard Error 0.66 |
| Group B - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.19 probability of remission | Standard Error 0.3 |
| Group B - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 12 Week HAMD-17 Total (n=194,n=59,n=195,n=64) | 0.18 probability of remission | Standard Error 0.34 |
| Group B - Placebo | Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint | 9 Month HAMD-17 Total Score (n=29,n=9,n=33,n=10) | 0.57 probability of remission | Standard Error 0.65 |
p-value: 0.731Mixed Models Analysis
p-value: 0.022Mixed Models Analysis
p-value: 0.948Mixed Models Analysis
p-value: 0.022Mixed Models Analysis
p-value: 0.95Mixed Models Analysis
p-value: 0.442Mixed Models Analysis
p-value: 0.218Mixed Models Analysis
p-value: 0.648Mixed Models Analysis
Secondary
Probability of Response at 12 Week Endpoint
Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.
Time frame: 12 weeks
Population: Number of participants with non-missing data at baseline and post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Probability of Response at 12 Week Endpoint | HAMD-17 Total Score (n=194,n=59,n=195,n=64) | 0.63 probability of response | Standard Error 0.16 |
| Group A - Duloxetine | Probability of Response at 12 Week Endpoint | QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.44 probability of response | Standard Error 0.15 |
| Group A - Placebo | Probability of Response at 12 Week Endpoint | QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.41 probability of response | Standard Error 0.26 |
| Group A - Placebo | Probability of Response at 12 Week Endpoint | HAMD-17 Total Score (n=194,n=59,n=195,n=64) | 0.60 probability of response | Standard Error 0.27 |
| Group B - Duloxetine | Probability of Response at 12 Week Endpoint | HAMD-17 Total Score (n=194,n=59,n=195,n=64) | 0.63 probability of response | Standard Error 0.16 |
| Group B - Duloxetine | Probability of Response at 12 Week Endpoint | QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.45 probability of response | Standard Error 0.16 |
| Group B - Placebo | Probability of Response at 12 Week Endpoint | HAMD-17 Total Score (n=194,n=59,n=195,n=64) | 0.46 probability of response | Standard Error 0.26 |
| Group B - Placebo | Probability of Response at 12 Week Endpoint | QIDS16 Total Score (n=194,n=58,n=194,n=62) | 0.34 probability of response | Standard Error 0.26 |
p-value: 0.653Mixed Models Analysis
p-value: 0.016Mixed Models Analysis
p-value: 0.665Mixed Models Analysis
p-value: 0.127Mixed Models Analysis
Secondary
Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint
Time frame: 9 months
Population: Number of participants with a normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Lymphocytes - High (n=189,n=59,n=196,n=66) | 1 participants |
| Group A - Duloxetine | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Hemoglobin - Low (n=184,n=54,n=184,n=63) | 5 participants |
| Group A - Placebo | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Hemoglobin - Low (n=184,n=54,n=184,n=63) | 2 participants |
| Group A - Placebo | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Lymphocytes - High (n=189,n=59,n=196,n=66) | 4 participants |
| Group B - Duloxetine | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Lymphocytes - High (n=189,n=59,n=196,n=66) | 1 participants |
| Group B - Duloxetine | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Hemoglobin - Low (n=184,n=54,n=184,n=63) | 2 participants |
| Group B - Placebo | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Lymphocytes - High (n=189,n=59,n=196,n=66) | 1 participants |
| Group B - Placebo | Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint | Hemoglobin - Low (n=184,n=54,n=184,n=63) | 4 participants |
p-value: 0.012Fisher Exact
p-value: 0.038Fisher Exact
Secondary
Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint
The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.
Time frame: over 3 months
Population: Number of participants with a normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Lymphocytes - High (n=186,n=57,n=195,n=66) | 1 participants |
| Group A - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Potassium - Low (n=191,n=57,n=201,n=66) | 0 participants |
| Group A - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Potassium - Low (n=191,n=57,n=201,n=66) | 0 participants |
| Group A - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Lymphocytes - High (n=186,n=57,n=195,n=66) | 3 participants |
| Group B - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Potassium - Low (n=191,n=57,n=201,n=66) | 1 participants |
| Group B - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Lymphocytes - High (n=186,n=57,n=195,n=66) | 2 participants |
| Group B - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Potassium - Low (n=191,n=57,n=201,n=66) | 3 participants |
| Group B - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint | Lymphocytes - High (n=186,n=57,n=195,n=66) | 1 participants |
p-value: 0.041Fisher Exact
p-value: 0.048Fisher Exact
Secondary
Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months
Time frame: over 9 months
Population: Number of participants with a normal baseline at at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Lymphocytes - High (n=189,n=59,n=196,n=66) | 1 participants |
| Group A - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Potassium - Low (n=194,n=59,n=202,n=67) | 0 participants |
| Group A - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Potassium - Low (n=194,n=59,n=202,n=67) | 0 participants |
| Group A - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Lymphocytes - High (n=189,n=59,n=196,n=66) | 4 participants |
| Group B - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Lymphocytes - High (n=189,n=59,n=196,n=66) | 2 participants |
| Group B - Duloxetine | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Potassium - Low (n=194,n=59,n=202,n=67) | 1 participants |
| Group B - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Lymphocytes - High (n=189,n=59,n=196,n=66) | 1 participants |
| Group B - Placebo | Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months | Potassium - Low (n=194,n=59,n=202,n=67) | 3 participants |
p-value: 0.012Fisher Exact
p-value: 0.049Fisher Exact
Secondary
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and at least one post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 9 Month Change (n=193,n=60,n=202,n=66) | -0.13 micromole per Liter | Standard Deviation 4.04 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Creatinine - 12 Week Change | -1.56 micromole per Liter | Standard Deviation 9.55 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 9 Month Change (n=193,n=60,n=202,n=66) | -2.11 micromole per Liter | Standard Deviation 48.77 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 12 Week Change | -2.77 micromole per Liter | Standard Deviation 48.2 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 12 Week Change | 0.10 micromole per Liter | Standard Deviation 4.09 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 12 Week Change | 5.74 micromole per Liter | Standard Deviation 41.92 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 9 Month Change (n=193,n=60,n=202,n=66) | -0.12 micromole per Liter | Standard Deviation 2.94 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 9 Month Change (n=193,n=60,n=202,n=66) | -2.25 micromole per Liter | Standard Deviation 42.59 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Creatinine - 12 Week Change | -0.85 micromole per Liter | Standard Deviation 8.27 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 12 Week Change | -0.19 micromole per Liter | Standard Deviation 3.63 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 12 Week Change | -12.36 micromole per Liter | Standard Deviation 46.02 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 12 Week Change | -0.51 micromole per Liter | Standard Deviation 3.92 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Creatinine - 12 Week Change | -1.21 micromole per Liter | Standard Deviation 8.95 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 9 Month Change (n=193,n=60,n=202,n=66) | -0.56 micromole per Liter | Standard Deviation 3.77 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 9 Month Change (n=193,n=60,n=202,n=66) | -8.66 micromole per Liter | Standard Deviation 47.85 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 9 Month Change (n=193,n=60,n=202,n=66) | 0.25 micromole per Liter | Standard Deviation 3.56 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Creatinine - 12 Week Change | 0.82 micromole per Liter | Standard Deviation 7.85 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Bilirubin - 12 Week Change | 0.13 micromole per Liter | Standard Deviation 3.64 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 12 Week Change | 7.05 micromole per Liter | Standard Deviation 44.2 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid | Uric Acid - 9 Month Change (n=193,n=60,n=202,n=66) | 6.50 micromole per Liter | Standard Deviation 44.8 |
p-value: 0.046ANOVA
p-value: 0.031ANOVA
p-value: 0.003ANOVA
p-value: 0.033ANOVA
p-value: 0.013ANOVA
Secondary
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and at least one post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Cholesterol - 9 Month (n=193,n=60,n=202,n=66) | -0.06 millimole per Liter | Standard Deviation 0.7 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Urea Nitrogen - 12 Week Change | -0.06 millimole per Liter | Standard Deviation 1.29 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Sodium - 9 Month Change (n=193,n=60,n=202,n=66) | -1.67 millimole per Liter | Standard Deviation 3.3 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 9 Month Change (n=193,n=60,n=202,n=66) | -0.74 millimole per Liter | Standard Deviation 2.92 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 12 Week Change | -0.80 millimole per Liter | Standard Deviation 2.85 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 9 Month Change (n=193,n=60,n=202,n=66) | 0.54 millimole per Liter | Standard Deviation 2.44 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Cholesterol - 9 Month (n=193,n=60,n=202,n=66) | -0.30 millimole per Liter | Standard Deviation 0.78 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Sodium - 9 Month Change (n=193,n=60,n=202,n=66) | -0.73 millimole per Liter | Standard Deviation 2.47 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Urea Nitrogen - 12 Week Change | 0.26 millimole per Liter | Standard Deviation 1.04 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 12 Week Change | 0.24 millimole per Liter | Standard Deviation 2.62 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 9 Month Change (n=193,n=60,n=202,n=66) | -0.82 millimole per Liter | Standard Deviation 2.71 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 12 Week Change | -0.91 millimole per Liter | Standard Deviation 2.75 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Urea Nitrogen - 12 Week Change | 0.01 millimole per Liter | Standard Deviation 1.2 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Cholesterol - 9 Month (n=193,n=60,n=202,n=66) | 0.04 millimole per Liter | Standard Deviation 0.75 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Sodium - 9 Month Change (n=193,n=60,n=202,n=66) | -1.86 millimole per Liter | Standard Deviation 3.16 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Cholesterol - 9 Month (n=193,n=60,n=202,n=66) | -0.08 millimole per Liter | Standard Deviation 0.51 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Urea Nitrogen - 12 Week Change | 0.15 millimole per Liter | Standard Deviation 1.38 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 12 Week Change | -0.39 millimole per Liter | Standard Deviation 2.51 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Chloride - 9 Month Change (n=193,n=60,n=202,n=66) | -0.31 millimole per Liter | Standard Deviation 2.4 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium | Sodium - 9 Month Change (n=193,n=60,n=202,n=66) | -1.73 millimole per Liter | Standard Deviation 3.12 |
p-value: 0.022ANOVA
p-value: 0.044ANOVA
p-value: 0.004ANOVA
p-value: 0.045ANOVA
p-value: 0.043ANOVA
Secondary
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and at least one post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 12 Week Change | -0.00 Proportion of 1.0 | Standard Deviation 0.03 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 9 Month Change (n=194,n=59,=197,n=67) | -0.00 Proportion of 1.0 | Standard Deviation 0.03 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 9 Month Change (n=194,n=59,=197,n=67) | -0.00 Proportion of 1.0 | Standard Deviation 0.03 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 12 Week Change | -0.01 Proportion of 1.0 | Standard Deviation 0.03 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 12 Week Change | 0.00 Proportion of 1.0 | Standard Deviation 0.03 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 9 Month Change (n=194,n=59,=197,n=67) | 0.00 Proportion of 1.0 | Standard Deviation 0.03 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 12 Week Change | -0.01 Proportion of 1.0 | Standard Deviation 0.03 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit | Hematocrit - 9 Month Change (n=194,n=59,=197,n=67) | -0.01 Proportion of 1.0 | Standard Deviation 0.03 |
p-value: 0.037ANOVA
p-value: 0.029ANOVA
Secondary
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and at least one post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 9 Month Change (n=194,n=59,n=197,n=67) | 1.07 femtoliter | Standard Deviation 2.9 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 12 Week Change | 0.98 femtoliter | Standard Deviation 2.85 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 12 Week Change | 1.30 femtoliter | Standard Deviation 3.3 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 9 Month Change (n=194,n=59,n=197,n=67) | 1.66 femtoliter | Standard Deviation 3.08 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 12 Week Change | 0.71 femtoliter | Standard Deviation 3.23 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 9 Month Change (n=194,n=59,n=197,n=67) | 0.88 femtoliter | Standard Deviation 3.36 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 9 Month Change (n=194,n=59,n=197,n=67) | -0.31 femtoliter | Standard Deviation 3.48 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV) | MCV - 12 Week Change | -0.47 femtoliter | Standard Deviation 3.18 |
p-value: 0.013ANOVA
p-value: 0.014ANOVA
Secondary
Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count
Time frame: Baseline, 12 weeks, 9 months
Population: Number of participants with non-missing data at baseline and at least post-baseline visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 12 Week Change | 8.11 Billions per Liter | Standard Deviation 37 |
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 9 Month Change (n=191, n=58, n=194, n=67) | 8.06 Billions per Liter | Standard Deviation 37.62 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 9 Month Change (n=191, n=58, n=194, n=67) | -10.17 Billions per Liter | Standard Deviation 35.73 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 12 Week Change | -7.10 Billions per Liter | Standard Deviation 38.83 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 12 Week Change | 10.55 Billions per Liter | Standard Deviation 37.53 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 9 Month Change (n=191, n=58, n=194, n=67) | 5.96 Billions per Liter | Standard Deviation 39.44 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 12 Week Change | 12.02 Billions per Liter | Standard Deviation 51.41 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count | 9 Month Change (n=191, n=58, n=194, n=67) | 10.18 Billions per Liter | Standard Deviation 51.19 |
p-value: 0.017ANOVA
p-value: 0.003ANOVA
Secondary
Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase
Time frame: baseline, 9 months
Population: Number of participants with non-missing data at baseline and at least one post baseline visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase | -0.18 Units per Liter | Standard Deviation 10.61 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase | -2.30 Units per Liter | Standard Deviation 10.2 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase | 0.23 Units per Liter | Standard Deviation 10.94 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase | -3.75 Units per Liter | Standard Deviation 8.19 |
p-value: 0.033ANOVA
Secondary
Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin
Time frame: Baseline, 9 months
Population: Number of participants with non-missing data at baseline and at least one post-baseline visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group A - Duloxetine | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin | -0.13 millimoles per Liter (iron) | Standard Deviation 0.45 |
| Group A - Placebo | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin | -0.19 millimoles per Liter (iron) | Standard Deviation 0.54 |
| Group B - Duloxetine | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin | -0.01 millimoles per Liter (iron) | Standard Deviation 0.47 |
| Group B - Placebo | Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin | -0.17 millimoles per Liter (iron) | Standard Deviation 0.53 |
p-value: 0.045ANOVA
Secondary
Summary of Adverse Events Leading to Discontinuation
Time frame: over 9 months
Population: Number of randomized participants in each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Muscular weakness | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Constipation | 2 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Cardiac failure congestive | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Mania | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Suicide attempt | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Crying | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Depressive symptom | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Lower limb fracture | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Rash | 2 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Depression | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Night sweats | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Lower gastrointestinal haemorrhage | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Wound infection staphylococcal | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Diarrhoea | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Tremor | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Disturbance in attention | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Pneumonia | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Irritability | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Influenza | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dry mouth | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Myocardial infarction | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Insomnia | 2 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Nausea | 5 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dysgeusia | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Abnormal dreams | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hypertension | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Fatigue | 2 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hepatic function abnormal | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Abdominal pain lower | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hyperhidrosis | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Headache | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hernia | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Nightmare | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Gamma-glutamyltransferase increased | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Ruptured cerebral aneurysm | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Chest pain | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Palpitations | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Astigmatism | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dizziness | 2 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Urinary retention | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Pruritus | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Anorgasmia | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Road traffic accident | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Restlessness | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Sexual dysfunction | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hepatic enzyme increased | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Pregnancy | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Asthma | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Somnolence | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Urinary hesitation | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Weight increased | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Completed suicide | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Sedation | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Blood pressure increased | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Paranoia | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Libido decreased | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Vomiting | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dyspepsia | 0 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Migraine | 1 participants |
| Group A - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Non-cardiac chest pain | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Tremor | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Cardiac failure congestive | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Depressive symptom | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Asthma | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Dyspepsia | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Gamma-glutamyltransferase increased | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Migraine | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Hepatic enzyme increased | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Libido decreased | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Blood pressure increased | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Night sweats | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Myocardial infarction | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Nightmare | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Palpitations | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Chest pain | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Pruritus | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Sexual dysfunction | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Headache | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Somnolence | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Sedation | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Completed suicide | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Vomiting | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Constipation | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Crying | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Depression | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Rash | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Diarrhoea | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Disturbance in attention | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Dry mouth | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Dysgeusia | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Hepatic function abnormal | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Fatigue | 2 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Hernia | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Hyperhidrosis | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Nausea | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Hypertension | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Influenza | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Insomnia | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Irritability | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Lower gastrointestinal haemorrhage | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Lower limb fracture | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Mania | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Suicide attempt | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Muscular weakness | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Non-cardiac chest pain | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Paranoia | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Pregnancy | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Weight increased | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Restlessness | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Road traffic accident | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Ruptured cerebral aneurysm | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Pneumonia | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Abdominal pain lower | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Urinary hesitation | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Dizziness | 1 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Urinary retention | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Wound infection staphylococcal | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Abnormal dreams | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Anorgasmia | 0 participants |
| Group A - Placebo | Summary of Adverse Events Leading to Discontinuation | Astigmatism | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Astigmatism | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Mania | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Migraine | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Urinary hesitation | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Headache | 2 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Anorgasmia | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Muscular weakness | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Suicide attempt | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Completed suicide | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Gamma-glutamyltransferase increased | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Non-cardiac chest pain | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Vomiting | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Sedation | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Abnormal dreams | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Paranoia | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Somnolence | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Sexual dysfunction | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Urinary retention | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Pregnancy | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Asthma | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Chest pain | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dyspepsia | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Restlessness | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Weight increased | 2 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Pruritus | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Cardiac failure congestive | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Road traffic accident | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Palpitations | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Nightmare | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Wound infection staphylococcal | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Ruptured cerebral aneurysm | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Myocardial infarction | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Blood pressure increased | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hernia | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Fatigue | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hepatic function abnormal | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dizziness | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hyperhidrosis | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Pneumonia | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dysgeusia | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Depressive symptom | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hypertension | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Dry mouth | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Rash | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Night sweats | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Influenza | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Libido decreased | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Disturbance in attention | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Tremor | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Irritability | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Insomnia | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Depression | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Abdominal pain lower | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Lower gastrointestinal haemorrhage | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Nausea | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Crying | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Hepatic enzyme increased | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Lower limb fracture | 1 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Diarrhoea | 0 participants |
| Group B - Duloxetine | Summary of Adverse Events Leading to Discontinuation | Constipation | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Vomiting | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Mania | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Nausea | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Dizziness | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Headache | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Rash | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Fatigue | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Insomnia | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Suicide attempt | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Weight increased | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Abdominal pain lower | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Abnormal dreams | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Asthma | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Blood pressure increased | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Chest pain | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Completed suicide | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Constipation | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Crying | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Depression | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Disturbance in attention | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Dry mouth | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Dysgeusia | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Hepatic function abnormal | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Hernia | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Hyperhidrosis | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Hypertension | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Influenza | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Irritability | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Lower gastrointestinal haemorrhage | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Lower limb fracture | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Migraine | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Muscular weakness | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Non-cardiac chest pain | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Paranoia | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Pregnancy | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Restlessness | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Road traffic accident | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Ruptured cerebral aneurysm | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Pneumonia | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Tremor | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Urinary hesitation | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Urinary retention | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Wound infection staphylococcal | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Anorgasmia | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Astigmatism | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Cardiac failure congestive | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Depressive symptom | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Dyspepsia | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Gamma-glutamyltransferase increased | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Hepatic enzyme increased | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Libido decreased | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Night sweats | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Myocardial infarction | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Nightmare | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Palpitations | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Pruritus | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Sexual dysfunction | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Somnolence | 0 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Sedation | 1 participants |
| Group B - Placebo | Summary of Adverse Events Leading to Discontinuation | Diarrhoea | 1 participants |