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Trial record 5 of 15 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Latvia )

Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735709
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Vortioxetine
Drug: Placebo
Enrollment 560
Recruitment Details Participants took part in the study at 51 investigative sites in Australia, Croatia, France, Germany, Latvia, Lithuania, Malaysia, Netherlands, Poland, Republic of Korea, Russia, South Africa, Taiwan, and Ukraine from 14 August 2008 to 13 August 2009.
Pre-assignment Details Participants with a diagnosis of major depressive disorder were randomized equally in 1 of 4 treatment groups, once daily placebo, 1 mg, 5 mg, or 10 mg vortioxetine.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Period Title: Overall Study
Started 140 140 140 140
Treated 140 140 140 139
Completed 127 127 129 122
Not Completed 13 13 11 18
Reason Not Completed
Adverse Event             2             3             1             5
Lack of Efficacy             8             4             2             3
Noncompliance             0             0             1             0
Protocol deviations             1             2             1             1
Voluntary Withdrawal             1             3             5             7
Lost to Follow-up             0             1             1             1
Excluded medication             1             0             0             1
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg Total
Hide Arm/Group Description Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 140 140 140 140 560
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
46.4  (12.26) 45.4  (11.89) 47.3  (11.95) 46.4  (12.27) 46.4  (12.08)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
≤55 years 103 110 102 107 422
>55 years 37 30 38 33 138
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
Female
86
  61.4%
93
  66.4%
87
  62.1%
85
  60.7%
351
  62.7%
Male
54
  38.6%
47
  33.6%
53
  37.9%
55
  39.3%
209
  37.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
Caucasian 120 129 120 114 483
Black 5 1 2 2 10
Asian 14 8 17 23 62
Other 1 2 1 1 5
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
Hispanic/Latino 3 0 0 1 4
Non-Hispanic/Non-Latino 137 140 140 139 556
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
Australia 0 3 0 1 4
Croatia 2 5 5 1 13
France 5 2 1 5 13
Germany 63 50 64 56 233
Latvia 5 8 9 5 27
Lithuania 4 4 2 3 13
Malaysia 7 3 6 6 22
Netherlands 0 3 3 1 7
Poland 20 16 15 11 62
Republic of Korea 7 5 9 14 35
Russia 12 20 9 20 61
South Africa 5 6 5 3 19
Taiwan 0 0 1 3 4
Ukraine 10 15 11 11 47
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
75.18  (14.924) 75.63  (17.276) 75.41  (17.022) 74.58  (15.190) 75.20  (16.099)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
168.70  (8.907) 168.56  (8.264) 168.56  (9.126) 168.70  (10.209) 168.63  (9.129)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
26.36  (4.615) 26.53  (5.380) 26.41  (5.065) 26.16  (4.612) 26.36  (4.917)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
Never smoked 88 74 88 79 329
Current smoker 34 54 33 41 162
Ex-smoker 18 12 19 20 69
Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
Never 53 51 56 54 214
Once monthly or less often 57 60 59 51 227
Once per week 16 13 9 16 54
2-to-6 times/week 5 11 7 12 35
Daily 9 5 9 7 30
24-item Hamilton Depression Scale total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
32.7  (4.40) 32.5  (5.13) 32.1  (5.04) 33.1  (4.77) 32.6  (4.84)
[1]
Measure Description: 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.
Montgomery Åsberg Depression Rating Scale (MADRS) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
30.6  (2.89) 30.4  (3.01) 30.6  (2.83) 31.6  (3.83) 30.8  (3.19)
[1]
Measure Description: 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).
Hamilton Anxiety Scale total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
19.7  (7.07) 20.0  (6.41) 19.4  (6.77) 21.1  (7.39) 20.0  (6.93)
[1]
Measure Description: 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.
Clinical Global Impression - Severity scale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
4.8  (0.80) 4.7  (0.73) 4.8  (0.73) 4.9  (0.76) 4.8  (0.76)
[1]
Measure Description: 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.
Hospital Anxiety and Depression (HAD) – Anxiety subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
11.2  (3.99) 11.2  (3.83) 11.6  (4.02) 11.7  (3.97) 11.4  (3.95)
[1]
Measure Description: The HAD-anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity).
Hospital Anxiety and Depression – Depression subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 140 participants 140 participants 140 participants 140 participants 560 participants
13.7  (4.33) 13.8  (3.88) 13.4  (4.02) 13.8  (3.71) 13.7  (3.99)
[1]
Measure Description: The HAD - Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity).
1.Primary Outcome
Title Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8
Hide Description 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 range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 128 124 129 122
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-11.30  (0.738) -14.82  (0.745) -15.42  (0.743) -16.23  (0.755)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.
Method Mixed model for repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.93
Confidence Interval (2-Sided) 95%
-6.99 to -2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.
Method Mixed model for repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.12
Confidence Interval (2-Sided) 95%
-6.17 to -2.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This treatment arm is not in the testing sequence, a nominal p-value is provided.
Method Mixed model for repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.52
Confidence Interval (2-Sided) 95%
-5.57 to -1.47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
Hide Description 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 94 90 97 83
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-6.54  (0.716) -6.58  (0.729) -7.65  (0.713) -8.08  (0.756)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments Pre-specified sequential statistical testing procedure indicates that when p-value >0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.
Method Mixed model repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-3.56 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.263
Comments [Not Specified]
Method Mixed model repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-3.07 to 0.84
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments [Not Specified]
Method Mixed model repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-2.03 to 1.94
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinical Global Impression Scale-Global Improvement at Week 8
Hide Description 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 128 124 129 122
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.84  (0.089) 2.37  (0.090) 2.37  (0.089) 2.29  (0.091)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-0.80 to -0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.71 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed model repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.72 to -0.23
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Responders in HAM-D24 Total Score at Week 8
Hide Description 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; last observation carried forward (LOCF) was used.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Measure Type: Number
Unit of Measure: percentage of participants
23.0 47.5 45.3 49.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Regression with explanatory variables for treatment and Baseline HAM-D24 score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.348
Confidence Interval (2-Sided) 95%
1.995 to 5.618
Estimation Comments Odds ratio versus placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Regression with explanatory variables for treatment and Baseline HAM-D24 score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.739
Confidence Interval (2-Sided) 95%
1.631 to 4.598
Estimation Comments Odds ratio versus placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Regression with explanatory variables for treatment and Baseline HAM-D24 score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.018
Confidence Interval (2-Sided) 95%
1.799 to 5.063
Estimation Comments Odds ratio versus placebo
5.Secondary Outcome
Title Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20
Hide Description 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. The 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 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 62 65 57 65
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-11.02  (1.017) -15.16  (0.991) -15.50  (1.063) -15.61  (0.984)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed model for repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.59
Confidence Interval (2-Sided) 95%
-7.34 to -1.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed model for repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.47
Confidence Interval (2-Sided) 95%
-7.32 to -1.62
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed model for repeated measurements
Comments P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.13
Confidence Interval (2-Sided) 95%
-6.90 to -1.37
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants in MADRS Remission at Week 8
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF was used.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Measure Type: Number
Unit of Measure: percentage of participants
16.5 25.9 28.8 26.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with explanatory variables for treatment and Baseline MADRS score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.951
Confidence Interval (2-Sided) 95%
1.082 to 3.517
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with explanatory variables for treatment and Baseline MADRS score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.056
Confidence Interval (2-Sided) 95%
1.150 to 3.673
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 1 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with explanatory variables for treatment and Baseline MADRS score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.753
Confidence Interval (2-Sided) 95%
0.973 to 3.158
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed
Hide Description 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 range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 137, 138, 138) -3.47  (0.321) -2.81  (0.323) -3.20  (0.322) -3.20  (0.321)
Week 2 (n=138, 138, 135, 135) -5.66  (0.485) -7.27  (0.485) -7.27  (0.490) -7.42  (0.489)
Week 4 (n=135, 133, 135, 127) -8.42  (0.634) -11.09  (0.637) -11.00  (0.639) -11.88  (0.646)
Week 6 (n=134, 130, 129, 126) -10.23  (0.690) -13.35  (0.695) -13.67  (0.697) -15.22  (0.705)
8.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed
Hide Description 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 104 103 106 99
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=104, 101, 105, 97) -1.22  (0.392) -1.13  (0.399) -1.78  (0.393) -1.43  (0.403)
Week 2 (n=102, 101, 100, 96) -2.53  (0.507) -3.44  (0.511) -4.14  (0.512) -3.40  (0.521)
Week 6 (n=99, 97, 97, 88) -5.95  (0.672) -5.69  (0.681) -6.92  (0.678) -8.27  (0.707)
9.Secondary Outcome
Title Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
Hide Description The Clinical Global Impression - global improvement 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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 137, 138, 138) 3.65  (0.053) 3.71  (0.054) 3.67  (0.053) 3.64  (0.053)
Week 2 (n=138, 138, 135, 135) 3.40  (0.069) 3.16  (0.070) 3.19  (0.070) 3.23  (0.070)
Week 4 (n=135, 133, 135, 127) 3.03  (0.082) 2.69  (0.083) 2.82  (0.083) 2.78  (0.084)
Week 6 (n=134, 130, 129, 126) 2.95  (0.087) 2.48  (0.088) 2.50  (0.088) 2.37  (0.089)
10.Secondary Outcome
Title Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed
Hide Description 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.
Time Frame Baseline and Weeks 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n=139, 137, 138, 138) 0.7 0.7 0.7 1.4
Week 2 (n=139, 139, 139, 139) 5.0 7.9 7.2 8.6
Week 4 (n=139, 139, 139, 139) 18.0 27.3 24.5 26.6
Week 6 (n=139, 139, 139, 139) 23.7 38.1 36.0 43.9
11.Secondary Outcome
Title Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20
Hide Description 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 range from 0 to 74 where a higher score indicates a greater depressive state. The 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 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 66 70 62 75
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=66, 70, 62, 75) -3.79  (0.473) -2.94  (0.463) -3.55  (0.491) -3.19  (0.447)
Week 2 (n=65, 70, 59, 72) -5.76  (0.637) -7.21  (0.618) -6.58  (0.667) -7.74  (0.607)
Week 4 (n=64, 68, 60, 69) -8.56  (0.874) -11.41  (0.850) -10.20  (0.910) -12.06  (0.841)
Week 6 (n=64, 67, 57, 68) -10.25  (0.958) -13.68  (0.932) -13.23  (1.002) -15.10  (0.923)
12.Secondary Outcome
Title Percentage of Participants in MADRS Remission at Other Weeks Assessed
Hide Description 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.
Time Frame Weeks 1, 2, 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n=139, 137, 138, 138) 0.7 0.7 0 0
Week 2 (n=139, 139, 139, 139) 2.2 2.2 1.4 1.4
Week 4 (n=139, 139, 139, 139) 6.5 11.5 11.5 10.8
Week 6 (n=139, 139, 139, 139) 10.1 20.1 20.9 22.3
13.Secondary Outcome
Title Percentage of Participants With a Sustained Response in HAM-D24 Total Score
Hide Description 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.
Time Frame From Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Measure Type: Number
Unit of Measure: percentage of participants
10.1 9.4 10.1 10.8
14.Secondary Outcome
Title Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week
Hide Description 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 a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 137, 138, 138) -2.90  (0.324) -2.55  (0.326) -2.66  (0.324) -2.57  (0.328)
Week 2 (n=138, 138, 135, 135) -4.92  (0.463) -6.65  (0.463) -6.40  (0.467) -6.51  (0.472)
Week 4 (n=135, 133, 135, 127) -7.85  (0.619) -10.79  (0.622) -10.30  (0.622) -10.89  (0.635)
Week 6 (n=134, 130, 129, 126) -9.72  (0.675) -13.16  (0.680) -13.10  (0.680) -14.19  (0.694)
Week 8 (n=128, 124, 129, 122) -10.91  (0.708) -14.89  (0.715) -15.09  (0.712) -15.65  (0.728)
15.Secondary Outcome
Title Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed
Hide Description 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 a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 137, 138, 138) -1.58  (0.260) -1.27  (0.261) -1.41  (0.261) -1.56  (0.261)
Week 2 (n=138, 138, 135, 135) -3.06  (0.343) -3.72  (0.343) -3.09  (0.346) -3.77  (0.347)
Week 4 (n=135, 133, 135, 127) -4.54  (0.416) -5.95  (0.418) -5.60  (0.418) -6.11  (0.425)
Week 6 (n=134, 130, 129, 126) -5.44  (0.471) -7.29  (0.475) -7.21  (0.476) -8.33  (0.483)
Week 8 (n=128, 124, 129, 122) -5.98  (0.498) -8.08  (0.503) -8.11  (0.501) -8.86  (0.511)
16.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed
Hide Description The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant'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 are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 1, 2, 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 137, 138, 138) -0.24  (0.044) -0.20  (0.045) -0.22  (0.044) -0.24  (0.044)
Week 2 (n=138, 138, 135, 135) -0.46  (0.062) -0.58  (0.062) -0.61  (0.062) -0.60  (0.062)
Week 4 (n=135, 133, 135, 127) -0.75  (0.080) -1.07  (0.081) -1.10  (0.081) -1.06  (0.082)
Week 6 (n=134, 130, 129, 126) -0.96  (0.092) -1.41  (0.093) -1.38  (0.093) -1.55  (0.094)
Week 8 (n=128, 124, 129, 122) -1.12  (0.101) -1.50  (0.102) -1.63  (0.101) -1.74  (0.103)
17.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed
Hide Description The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis
Time Frame Baseline and Weeks 1, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 138
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Anxiety Scale at Week 1 (n=139, 137, 138, 137) -0.46  (0.190) -1.14  (0.190) -0.87  (0.189) -0.91  (0.190)
Anxiety Scale at Week 4 (n=137, 138, 135, 134) -1.95  (0.277) -2.83  (0.276) -2.81  (0.278) -2.80  (0.279)
Anxiety Scale at Week 8 (n=129, 129, 127, 122) -2.55  (0.315) -3.79  (0.315) -3.70  (0.317) -4.38  (0.321)
Depression Scale at Week 1 (n=139, 137, 138, 137) -0.32  (0.217) -0.90  (0.217) -0.74  (0.216) -0.92  (0.218)
Depression Scale at Week 4 (n=137, 138, 135, 134) -2.32  (0.348) -3.45  (0.347) -3.32  (0.350) -3.80  (0.352)
Depression Scale at Week 8 (n=129, 129, 127, 122) -3.19  (0.392) -4.67  (0.393) -5.02  (0.396) -5.49  (0.401)
18.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138,139,136,136) 2.24  (1.279) 5.39  (1.273) 7.55  (1.285) 3.34  (1.289)
Week 4 (n=135,132,135,128) 5.10  (1.354) 7.77  (1.364) 9.35  (1.356) 6.92  (1.385)
Week 8 (n=129,129,128,122) 8.77  (1.407) 9.59  (1.408) 12.31  (1.411) 11.28  (1.441)
19.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 0.74  (1.511) 6.09  (1.505) 7.38  (1.520) 5.00  (1.525)
Week 4 (n=135, 132, 135, 128) 4.53  (1.706) 10.62  (1.721) 12.97  (1.709) 8.28  (1.748)
Week 8 (n=129, 129, 128, 122) 8.46  (1.830) 14.09  (1.833) 15.64  (1.835) 15.76  (1.878)
20.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 2.99  (1.630) 5.06  (1.624) 4.52  (1.644) 7.22  (1.644)
Week 4 (n=135, 132, 135, 128) 4.45  (1.738) 5.33  (1.752) 7.75  (1.744) 10.66  (1.778)
Week 8 (n=129, 129, 128, 122) 7.17  (1.920) 11.99  (1.920) 9.63  (1.928) 12.89  (1.970)
21.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 2.83  (1.048) 5.54  (1.044) 5.64  (1.054) 5.47  (1.056)
Week 4 (n=135, 132, 135, 128) 6.51  (1.235) 8.98  (1.245) 9.96  (1.238) 10.99  (1.263)
Week 8 (n=129, 129, 128, 121) 8.68  (1.392) 12.46  (1.395) 13.67  (1.396) 13.87  (1.429)
22.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 5.97  (1.199) 10.39  (1.193) 8.83  (1.205) 8.03  (1.208)
Week 4 (n=135, 132, 135, 128) 12.06  (1.523) 16.69  (1.536) 16.04  (1.526) 16.07  (1.560)
Week 8 (n=129, 129, 128, 122) 16.14  (1.748) 22.34  (1.752) 21.21  (1.753) 24.17  (1.793)
23.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 6.38  (1.479) 9.71  (1.473) 12.02  (1.486) 10.03  (1.491)
Week 4 (n=135, 132, 135, 128) 12.34  (1.760) 15.71  (1.775) 18.57  (1.762) 15.84  (1.804)
Week 8 (n=129, 129, 128, 122) 15.60  (1.989) 21.71  (1.991) 21.87  (1.993) 24.94  (2.040)
24.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 6.84  (1.570) 8.78  (1.563) 10.87  (1.579) 9.93  (1.581)
Week 4 (n=135, 132, 135, 128) 12.05  (1.755) 17.01  (1.772) 18.08  (1.758) 14.58  (1.797)
Week 8 (n=129, 129, 128, 122) 15.96  (1.941) 23.06  (1.946) 22.89  (1.947) 24.71  (1.990)
25.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed
Hide Description The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.
Time Frame Baseline and Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 137 136
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=138, 139, 136, 136) 6.98  (1.199) 10.62  (1.192) 9.56  (1.205) 10.26  (1.207)
Week 4 (n= 135, 132, 135, 128) 13.06  (1.418) 16.78  (1.429) 16.56  (1.421) 16.38  (1.451)
Week 8 (n=129, 129, 128, 122) 16.28  (1.625) 23.61  (1.628) 22.24  (1.631) 24.89  (1.667)
26.Secondary Outcome
Title Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.
Hide Description Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the 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.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
Overall Number of Participants Analyzed 139 139 139 139
Measure Type: Number
Unit of Measure: participants
Baseline: Any resource use 62 64 71 61
Baseline: Any hospitalization-related services 4 3 6 4
Baseline: Hospitalization related to depression 3 3 4 2
Baseline: Any sick leave 17 7 14 21
Baseline: Sick leave related to depression 12 6 10 18
Week 8: Any resource use 31 13 25 25
Week 8: Any hospitalization-related service 3 0 1 2
Week 8: Hospitalization related to depression 0 0 1 0
Week 8: Any sick leave 16 6 11 18
Week 8: Sick leave related to depression 13 6 9 14
Time Frame Treatment-emergent adverse events are defined as adverse events whose onset occurred or intensity increased after the first dose of double-blind study drug through 30 days after permanent discontinuation of double-blind study drug.
Adverse Event Reporting Description 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.
 
Arm/Group Title Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Hide Arm/Group Description Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
All-Cause Mortality
Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/140 (1.43%)   1/140 (0.71%)   1/140 (0.71%)   2/139 (1.44%) 
Cardiac disorders         
Tachycardia  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/139 (0.00%) 
Gastrointestinal disorders         
Pancreatitis  1  1/140 (0.71%)  0/140 (0.00%)  0/140 (0.00%)  1/139 (0.72%) 
Nervous system disorders         
Dizziness  1  1/140 (0.71%)  0/140 (0.00%)  0/140 (0.00%)  0/139 (0.00%) 
Psychiatric disorders         
Suicide attempt  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  1/139 (0.72%) 
Vascular disorders         
Hypertensive crisis  1  0/140 (0.00%)  1/140 (0.71%)  0/140 (0.00%)  0/139 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Vortioxetine 1 mg Vortioxetine 5 mg Vortioxetine 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/140 (27.86%)   36/140 (25.71%)   56/140 (40.00%)   39/139 (28.06%) 
Cardiac disorders         
Tachycardia  1  3/140 (2.14%)  0/140 (0.00%)  0/140 (0.00%)  1/139 (0.72%) 
Ear and labyrinth disorders         
Vertigo  1  1/140 (0.71%)  3/140 (2.14%)  4/140 (2.86%)  3/139 (2.16%) 
Gastrointestinal disorders         
Nausea  1  6/140 (4.29%)  11/140 (7.86%)  22/140 (15.71%)  18/139 (12.95%) 
Abdominal pain upper  1  5/140 (3.57%)  2/140 (1.43%)  1/140 (0.71%)  1/139 (0.72%) 
Diarrhoea  1  2/140 (1.43%)  2/140 (1.43%)  3/140 (2.14%)  4/139 (2.88%) 
Dry mouth  1  3/140 (2.14%)  2/140 (1.43%)  3/140 (2.14%)  3/139 (2.16%) 
Constipation  1  1/140 (0.71%)  2/140 (1.43%)  3/140 (2.14%)  1/139 (0.72%) 
General disorders         
Fatigue  1  0/140 (0.00%)  3/140 (2.14%)  5/140 (3.57%)  1/139 (0.72%) 
Infections and infestations         
Nasopharyngitis  1  8/140 (5.71%)  5/140 (3.57%)  7/140 (5.00%)  3/139 (2.16%) 
Influenza  1  2/140 (1.43%)  2/140 (1.43%)  5/140 (3.57%)  2/139 (1.44%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  5/140 (3.57%)  2/140 (1.43%)  3/140 (2.14%)  1/139 (0.72%) 
Nervous system disorders         
Headache  1  11/140 (7.86%)  9/140 (6.43%)  16/140 (11.43%)  7/139 (5.04%) 
Dizziness  1  3/140 (2.14%)  1/140 (0.71%)  5/140 (3.57%)  9/139 (6.47%) 
Somnolence  1  2/140 (1.43%)  1/140 (0.71%)  3/140 (2.14%)  3/139 (2.16%) 
Sedation  1  0/140 (0.00%)  0/140 (0.00%)  3/140 (2.14%)  0/139 (0.00%) 
Psychiatric disorders         
Restlessness  1  1/140 (0.71%)  1/140 (0.71%)  3/140 (2.14%)  2/139 (1.44%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  1/140 (0.71%)  0/140 (0.00%)  3/140 (2.14%)  2/139 (1.44%) 
Vascular disorders         
Hypertension  1  3/140 (2.14%)  0/140 (0.00%)  1/140 (0.71%)  1/139 (0.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00735709     History of Changes
Other Study ID Numbers: LuAA21004_305
2008-001580-11 ( EudraCT Number )
U1111-1114-0326 ( Registry Identifier: WHO )
First Submitted: August 14, 2008
First Posted: August 15, 2008
Results First Submitted: October 25, 2013
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013