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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMFL | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients with major depressive disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine 60 mg with food | Experimental | Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks |
|
| Duloxetine 60 mg without food | Experimental | Duloxetine 60 mg capsule po QD without food for 8 weeks |
|
| Duloxetine 30 mg with food | Experimental | Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks |
|
| Duloxetine 30 mg without food | Experimental | Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine hydrochloride | Drug | po, QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea) | AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. | 1 week and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea) | Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cheong Ju-City | 361-711 |
Period 1 was a 3- to 30-day screening and washout period; Period 2 (Week 0-1) was a 1-week initial dosing period (randomization to duloxetine 30 mg with food, 30 mg without food, 60 mg with food, or 60 mg without food); Period 3 (Week 1-8) was a 7-week therapy period (treatment switched to duloxetine 60 mg once daily (QD) until study end.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine 60 mg With Food | Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks |
| FG001 | Duloxetine 60 mg Without Food | Duloxetine 60 mg capsule po QD without food for 8 weeks |
| FG002 | Duloxetine 30 mg With Food | Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks |
| FG003 | Duloxetine 30 mg Without Food | Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Screening and Washout) |
|
| ||||||||||||||||||
| Period 2 (1-week Initial Dosing Period) |
| |||||||||||||||||||
| Period 3 (7-week Therapy Period) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine 60 mg With Food | Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks |
| BG001 | Duloxetine 60 mg Without Food | Duloxetine 60 mg capsule po QD without food for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea) | AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. | The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 week and 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine 30 mg With Food | Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
Large number of protocol violations; bias due to unblinded, open-label design (participants were predisposed to expect an outcome of nausea as the primary endpoint); use of emetogenic medications; incorrect reporting and intake of food and drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Baseline, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score | Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | Baseline, 1 week and 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score | AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score | The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale | The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the "core" symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale | The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale | The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale | The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale | The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | Baseline, 1 week, 8 weeks |
| Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S) | The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix. | Baseline, 1 week, 8 weeks |
| Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks | The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix. | 1 week, 8 weeks |
| Time to Onset of Nausea | Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study. | Baseline to onset of nausea (Baseline up to 8 weeks) |
| Time to Resolve Nausea | Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study. | Nausea onset up to nausea resolve (Baseline up to 8 weeks) |
| Percentage of Participants Achieving Response | Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed). | Baseline up to 8 weeks |
| Percentage of Patients Achieving Remission | Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed). | Baseline up to 8 weeks |
| South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Goyang-si | 410-719 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seongnam-si | 463-707 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | 134-791 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sungnam-Si | 463-712 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Suwon | 442-721 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Yangsan | 626-770 | South Korea |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Duloxetine 30 mg With Food | Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks |
| BG003 | Duloxetine 30 mg Without Food | Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | BMI measures the participant's body weight divided by the square of his or her height. | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Previously diagnosed with major depressive disorder (MDD) | Number | participants |
|
| Duration since first major depressive disorder (MDD) episode | Median | Inter-Quartile Range | years |
|
| Age at first major depressive disorder (MDD) episode | Mean | Inter-Quartile Range | years |
|
| Number of previous MDD episodes/exacerbations in the last 24 months | Median | Inter-Quartile Range | number of episodes in last 24 months |
|
| Received previous therapy for current episode | Number | participants |
|
| 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score | The HAMD-17 measured depression severity. Each item was evaluated and scored using either a 5-point scale (for example, absent; mild; moderate; severe; very severe) or a 3-point scale (for example, absent; mild; marked). The total score ranged from 0 (not at all depressed)-52 (severely depressed). | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impression of Severity (CGI-S) Score | The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. | Mean | Inter-Quartile Range | units on a scale |
|
| Association for Methodology and Documentation in Psychiatry (AMDP-5) Item 112 (Nausea) Score | AMDP-5 Item 112 (nausea) measured nausea severity. The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. | Mean | Standard Deviation | units on a scale |
|
Duloxetine 60 mg capsule po QD without food for 8 weeks
| OG002 | Duloxetine 30 mg With Food | Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks |
| OG003 | Duloxetine 30 mg Without Food | Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks |
|
|
| Secondary | Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea) | Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. N = number of subjects with a baseline and post-baseline result at the Week 8 visit. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score | Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week and 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score | AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity. | The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score | The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale | The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the "core" symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale | The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale | The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale | The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale | The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S) | The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 1 week, 8 weeks |
|
|
|
| Secondary | Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks | The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix. | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Least Squares Mean | Standard Error | units on a scale | 1 week, 8 weeks |
|
|
|
| Secondary | Time to Onset of Nausea | Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study. | The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. | Posted | Median | 95% Confidence Interval | days | Baseline to onset of nausea (Baseline up to 8 weeks) |
|
|
|
| Secondary | Time to Resolve Nausea | Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study. | The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. | Posted | Median | 95% Confidence Interval | days | Nausea onset up to nausea resolve (Baseline up to 8 weeks) |
|
|
|
| Secondary | Percentage of Participants Achieving Response | Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed). | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Number | percentage of participants | Baseline up to 8 weeks |
|
|
|
| Secondary | Percentage of Patients Achieving Remission | Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed). | The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned. | Posted | Number | percentage of participants | Baseline up to 8 weeks |
|
|
|
| 1 |
| 63 |
| 52 |
| 63 |
| EG001 | Duloxetine 60 mg With Food | Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks | 1 | 59 | 55 | 59 |
| EG002 | Duloxetine 30 mg Without Food | Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks | 2 | 64 | 57 | 64 |
| EG003 | Duloxetine 60 mg Without Food | Duloxetine 60 mg capsule po QD without food for 8 weeks | 0 | 63 | 58 | 63 |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Muscle injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided
| D006571 |
| Heterocyclic Compounds |
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|
| 8-week change (n=28; n=37; n=39; n=37) |
|