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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-3497 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.
The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 2.5 mg | Experimental | Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
|
| Vortioxetine 5 mg | Experimental | Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
|
| Duloxetine 60 mg | Active Comparator | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period. |
|
| Placebo | Placebo Comparator | Placebo-matching capsules, orally, once daily for up to 9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Encapsulated vortioxetine immediate-release tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 | The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate. |
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Inclusion Criteria:
Exclusion Criteria:
Has 1 or more the following:
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23252878 | Result | Mahableshwarkar AR, Jacobsen PL, Chen Y. A randomized, double-blind trial of 2.5 mg and 5 mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin. 2013 Mar;29(3):217-26. doi: 10.1185/03007995.2012.761600. Epub 2013 Jan 17. |
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Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 2.5 mg, 5 mg vortioxetine, or 60 mg duloxetine.
Participants took part in the study at 47 investigative sites in the United States from 10 April 2008 to 30 December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching capsules, orally, once daily for up to 9 weeks. |
| FG001 | Vortioxetine 2.5 mg | Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Duloxetine | Drug | Duloxetine capsules |
|
|
| Placebo | Drug | Placebo-matching capsules |
|
| Baseline and Weeks 1, 2, 4, and 6 |
| Percentage of Responders in HAM-D 24 Total Score by Study Visit | A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. | Baseline and Weeks 1, 2, 4, 6 and 8. |
| Percentage of Participants With a Sustained Response in HAM-D24 | A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8. | Baseline to Week 8 |
| Percentage of Participants in MADRS Remission at Week 8 | Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Week 8 |
| Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Baseline and Weeks 1, 2, 4, 6 and 8 |
| Clinical Global Impression Scale-Global Improvement Scale | The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on 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. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate. | Baseline and Weeks 1, 2, 4, 6 and 8. |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) | The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Baseline and Weeks 1, 4 and 8 |
| Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Baseline and Weeks 1, 2, 4, 6 and 8. |
| Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following 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. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Baseline and Weeks 1, 2, 4, 6 and 8. |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Baseline and Week 8 |
| Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. | Baseline and Week 8 |
| Irvine |
| California |
| United States |
| Santa Ana | California | United States |
| Torrance | California | United States |
| Upland | California | United States |
| Bradenton | Florida | United States |
| Coral Springs | Florida | United States |
| Fort Walton Beach | Florida | United States |
| Gainesville | Florida | United States |
| Jacksonville | Florida | United States |
| Maitland | Florida | United States |
| Orlando | Florida | United States |
| South Miami | Florida | United States |
| West Palm Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Smyrna | Georgia | United States |
| Chicago | Illinois | United States |
| Libertyville | Illinois | United States |
| Oak Brook | Illinois | United States |
| Prairie Village | Kansas | United States |
| Owensboro | Kentucky | United States |
| Baltimore | Maryland | United States |
| Pittsfield | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Flowood | Mississippi | United States |
| New York | New York | United States |
| Olean | New York | United States |
| Beachwood | Ohio | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Allenport | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Austin | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Seattle | Washington | United States |
| Milwaukee | Wisconsin | United States |
| FG002 | Vortioxetine 5 mg | Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| FG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching capsules, orally, once daily for up to 9 weeks. |
| BG001 | Vortioxetine 2.5 mg | Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| BG002 | Vortioxetine 5 mg | Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| BG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number of participants for whom Race data were available were 153, 153, 151 and 151 respectively. | Number | participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Number of participants for whom Ethnicity data were available were 153, 153, 152 and 151 respectively. | Number | participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Smoking Classification | Number | participants |
| ||||||||||||||||
| Alcohol consumption | Number | participants |
| ||||||||||||||||
| 24-item Hamilton Depression Scale total score | The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Montgomery Åsberg Depression Rating Scale (MADRS) total score | The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Hamilton Anxiety Scale Total Score | Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Clinical Global Impression - Severity scale score | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following 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 | Standard Deviation | scores on a scale |
|
| 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 | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 | The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate. | The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug and had at least 1 valid postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 8 |
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| Secondary | Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed | The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate. | Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Weeks 1, 2, 4, and 6 |
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| Secondary | Percentage of Responders in HAM-D 24 Total Score by Study Visit | A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state. | Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Number | percentage of participants | Baseline and Weeks 1, 2, 4, 6 and 8. |
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| Secondary | Percentage of Participants With a Sustained Response in HAM-D24 | A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8. | Full analysis set with available data. | Posted | Number | percentage of participants | Baseline to Week 8 |
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| Secondary | Percentage of Participants in MADRS Remission at Week 8 | Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. | Full analysis set; LOCF was used. | Posted | Number | percentage of participants | Week 8 |
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| Secondary | Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Weeks 1, 2, 4, 6 and 8 |
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| Secondary | Clinical Global Impression Scale-Global Improvement Scale | The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on 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. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate. | Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Weeks 1, 2, 4, 6 and 8. |
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| Secondary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) | The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Full analysis set with available data at Baseline; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Weeks 1, 4 and 8 |
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| Secondary | Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score | The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Weeks 1, 2, 4, 6 and 8. |
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| Secondary | Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following 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. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Full analysis set; LOCF was used. "n" indicates the number of patients included in the analysis at each time point. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Weeks 1, 2, 4, 6 and 8. |
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| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate. | Full analysis set with available data at Baseline; LOCF was used. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 8 |
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| Secondary | Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire | Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks. | Full analysis set | Posted | Number | participants | Baseline and Week 8 |
|
Adverse events were collected during the 8-week treatment period and a 4-week follow-up period.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo-matching capsules, orally, once daily for up to 9 weeks. | 2 | 151 | 81 | 151 | ||
| EG001 | Vortioxetine 2.5 mg | Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. | 0 | 149 | 83 | 149 | ||
| EG002 | Vortioxetine 5 mg | Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. | 3 | 153 | 87 | 153 | ||
| EG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. | 2 | 150 | 120 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Orgasm abnormal | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >55 years |
|
| Male |
|
| Black |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian/ Other Pacific Islander |
|
| Non-Hispanic/Non-Latino |
|
| Current smoker |
|
| Ex-smoker |
|
| Once monthly or less often |
|
| Once per week |
|
| 2-to-6 times/week |
|
| Daily |
|
| No |
| Superiority or Other |
| ANCOVA | ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate. | 0.138 | LS Mean Difference | -1.54 | Standard Error of the Mean | 1.038 | 2-Sided | 95 | -3.58 | 0.50 | No | Superiority or Other |
| ANCOVA | ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate. | 0.005 | LS Mean Difference | -2.96 | Standard Error of the Mean | 1.047 | 2-Sided | 95 | -5.02 | -0.91 | No | Superiority or Other |
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
|
|
| Duloxetine 60 mg |
Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. |
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
| OG003 | Duloxetine 60 mg | Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|
Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period. |
|
|