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An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00734071
Recruitment Status : Completed
First Posted : August 13, 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 Generalized Anxiety Disorder
Interventions Drug: Vortioxetine
Drug: Placebo
Enrollment 304
Recruitment Details Participants took part in the study at 33 investigative sites in the United States from 25 June 2008 to 06 March 2009.
Pre-assignment Details Participants with a diagnosis of generalized anxiety disorder were enrolled equally in one of two treatment groups, once a day placebo or 5 mg vortioxetine.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Period Title: Overall Study
Started 152 152
Treated 151 148
Completed 114 125
Not Completed 38 27
Reason Not Completed
Adverse Event             4             3
Lack of Efficacy             3             1
Noncompliance             2             2
Protocol Deviations             3             4
Voluntary Withdrawal             9             7
Lost to Follow-up             16             8
Other             1             2
Arm/Group Title Placebo Vortioxetine 5 mg Total
Hide Arm/Group Description Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 152 152 304
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 152 participants 304 participants
41.4  (12.81) 41.0  (14.05) 41.2  (13.42)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
≤55 years 128 129 257
>55 years 24 23 47
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Female
97
  63.8%
103
  67.8%
200
  65.8%
Male
55
  36.2%
49
  32.2%
104
  34.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Caucasian (White, including Hispanic) 131 123 254
Black 17 24 41
Asian 2 3 5
American Indian or Alaska Native 0 2 2
Native Hawaiian/ Other Pacific Islander 2 0 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Hispanic/Latino 24 26 50
Non-Hispanic/Non-Latino 128 126 254
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 152 participants 152 participants 304 participants
152 152 304
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 152 participants 152 participants 304 participants
83.68  (20.916) 80.10  (20.296) 81.89  (20.652)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 152 participants 152 participants 304 participants
167.73  (8.765) 167.72  (9.158) 167.73  (8.949)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 152 participants 152 participants 304 participants
29.66  (6.861) 28.42  (6.680) 29.04  (6.789)
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Never Smoked 78 76 154
Current Smoker 38 43 81
Ex-smoker 36 33 69
Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 152 participants 304 participants
Never 48 39 87
Once monthly or less often 57 55 112
Once a week 17 28 45
2 to 6 times per week 27 27 54
Daily 3 3 6
Hamilton Anxiety Scale Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 152 participants 304 participants
24.6  (3.60) 24.7  (3.79) 24.7  (3.69)
[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 (absent) to 56 (maximum severity).
Clinical Global Impression - Severity scale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 152 participants 304 participants
4.3  (0.49) 4.3  (0.53) 4.3  (0.51)
[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. The number of participants with available data were 151 and 152 in each treatment arm respectively.
Hospital Anxiety and Depression – Anxiety subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 152 participants 304 participants
13.5  (3.14) 13.8  (3.39) 13.7  (3.26)
[1]
Measure Description: Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). The number of participants with available data were 149 and 151 in each treatment arm respectively.
Hospital Anxiety and Depression – Depression subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 152 participants 304 participants
8.5  (3.79) 8.1  (3.91) 8.3  (3.85)
[1]
Measure Description: Hospital Anxiety and Depression (HAD) Depression sub-scale consists of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). The depression subscale focuses on the state of lost interest and diminished pleasure response. Scores are summed and range from 0 to 21 (maximal severity). The number of participants with available data were 149 and 151 in each treatment arm respectively.
Montgomery Åsberg Depression Rating Scale (MADRS) total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 152 participants 304 participants
11.83  (3.007) 12.09  (2.902) 11.96  (2.953)
[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).
1.Primary Outcome
Title Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
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. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 113 124
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-13.16  (0.655) -12.57  (0.646)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments P-values were tested at the 5% level of significance (ie, statistical significance if P<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 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 0.518
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 for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
-1.20 to 2.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.911
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8
Hide Description The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 111 124
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-4.84  (0.392) -5.06  (0.384)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.
Method Mixed model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-1.29 to 0.85
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.542
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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Week 8
Show Outcome Measure DataHide 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 113 124
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.25  (0.101) 2.25  (0.099)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.984
Comments Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.
Method Mixed model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.27 to 0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.141
Estimation Comments [Not Specified]
4.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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Week 8
Show Outcome Measure DataHide 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 91 97
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-6.68  (0.618) -6.35  (0.616)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.703
Comments Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.
Method Mixed model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
-1.38 to 2.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.866
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Responders in HAM-A Total Score at Week 8
Hide Description Response was defined as participants with a ≥50% decrease 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 (symptoms absent) to 56 (maximum severity).
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Last observation carried forward was used.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 144 145
Measure Type: Number
Unit of Measure: percentage of participants
50.0 53.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.602
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with explanatory variables for treatment and Baseline HAM-A score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.131
Confidence Interval (2-Sided) 95%
0.713 to 1.795
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25
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. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 59 63
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-14.04  (1.104) -14.05  (1.080)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.995
Comments Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.
Method Mixed model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-3.09 to 3.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.558
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8
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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 113 125
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
17.43  (2.133) 18.44  (2.091)
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 0.731
Comments Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.
Method Mixed model for repeated measurements
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
-4.79 to 6.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.951
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks 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. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1, 2, 4 and 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set. 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 144 145
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=141, 144) -4.84  (0.415) -4.59  (0.422)
Week 2 (n=134, 142) -7.78  (0.542) -8.22  (0.541)
Week 4 (n=131, 135) -10.13  (0.590) -9.82  (0.590)
Week 6 (n=124, 129) -12.39  (0.632) -11.61  (0.630)
9.Secondary Outcome
Title Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed
Hide Description The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1 and 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 140 144
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 142) -1.81  (0.269) -2.07  (0.273)
Week 4 (n=130, 135) -3.41  (0.328) -3.72  (0.329)
10.Secondary Outcome
Title Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed
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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1, 2, 4 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 144 145
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=141, 144) 3.32  (0.066) 3.38  (0.066)
Week 2 (n=134, 142) 2.92  (0.081) 2.83  (0.081)
Week 4 (n=131, 135) 2.57  (0.089) 2.57  (0.089)
Week 6 (n=124, 129) 2.42  (0.096) 2.39  (0.095)
11.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 and P-values were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1, 2 and 4
Show Outcome Measure DataHide 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 124 121
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=117, 116) -2.13  (0.484) -2.46  (0.497)
Week 2 (n=109, 114) -4.35  (0.566) -4.02  (0.572)
Week 4 (n=106, 108) -5.57  (0.587) -5.38  (0.593)
12.Secondary Outcome
Title Percentage of Responders in HAM-A Total Score at Other Weeks Assessed
Hide Description Response was defined as participants with a ≥50% decrease 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 (symptoms absent) to 56 (maximum severity).
Time Frame Baseline and Weeks 1, 2, 4 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Last observation carried forward was used; "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 144 145
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n=141, 144) 9.9 6.9
Week 2 (n=144, 145) 22.9 24.1
Week 4 (n=144, 145) 34.7 37.2
Week 6 (n=144, 145) 47.2 45.5
13.Secondary Outcome
Title Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25
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. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1, 2, 4 and 6
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Hide Analysis Population Description
Full analysis set patients with a HAM-A Baseline score ≥25. 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 73 71
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=71, 71) -5.39  (0.675) -4.73  (0.648)
Week 2 (n=70, 70) -8.37  (0.889) -8.94  (0.873)
Week 4 (n=67, 67) -10.90  (0.994) -10.74  (0.980)
Week 6 (n=63, 65) -13.60  (1.040) -12.82  (1.021)
14.Secondary Outcome
Title Percentage of Participants in HAM-A Remission at Each Week Assessed
Hide Description Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. 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 (symptoms absent) to 56 (maximum severity).
Time Frame Weeks 1, 2, 4, 6 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Last observation carried forward was used. "n" indicates the number of patients included in the analysis at each time point.
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 144 145
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 (n-141, 144) 2.1 0.7
Week 2 (n=144, 145) 5.6 7.6
Week 4 (n=144, 145) 15.3 12.4
Week 6 (n=144, 145) 22.2 22.1
Week 8 (n=144, 145) 22.2 25.5
15.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 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 a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1, 2, 4, 6 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 144 145
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=141, 144) -0.37  (0.057) -0.38  (0.058)
Week 2 (n=134, 142) -0.75  (0.081) -0.86  (0.081)
Week 4 (n=131, 135) -1.15  (0.093) -1.05  (0.092)
Week 6 (n=124, 129) -1.45  (0.098) -1.40  (0.097)
Week 8 (n=113, 124) -1.72  (0.104) -1.54  (0.102)
16.Secondary Outcome
Title Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed
Hide 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). LS means were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 1, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 140 144
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 1 (n=139, 142) -1.02  (0.226) -1.09  (0.228)
Week 4 (n=130, 135) -1.84  (0.273) -2.28  (0.273)
Week 8 (n=111, 124) -2.55  (0.316) -2.62  (0.308)
17.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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2 and 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 11.96  (1.803) 14.06  (1.820)
Week 4 (n=129, 134) 17.12  (1.993) 16.22  (1.999)
18.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 1.54  (1.322) 3.69  (1.336)
Week 4 (n=129, 134) 4.76  (1.424) 4.22  (1.432)
Week 8 (n=113, 125) 3.50  (1.640) 4.18  (1.609)
19.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 5.03  (1.901) 4.90  (1.906)
Week 4 (n=129, 134) 8.65  (1.966) 5.19  (1.967)
Week 8 (n=113, 125) 10.02  (1.998) 7.74  (1.953)
20.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 7.24  (1.743) 6.49  (1.755)
Week 4 (n=129, 134) 9.81  (1.756) 8.96  (1.761)
Week 8 (n=113, 125) 10.14  (1.965) 8.58  (1.915)
21.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 2.79  (1.095) 3.61  (1.109)
Week 4 (n=129, 134) 4.85  (1.204) 1.76  (1.212)
Week 8 (n=113, 125) 6.14  (1.391) 3.90  (1.365)
22.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 8.91  (1.528) 10.46  (1.555)
Week 4 (n=129, 134) 12.48  (1.655) 12.67  (1.671)
Week 8 (n=113, 125) 16.06  (1.828) 14.65  (1.805)
23.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 14.54  (2.028) 13.25  (2.041)
Week 4 (n=129, 134) 16.00  (2.055) 15.00  (2.063)
Week 8 (n=113, 125) 21.64  (2.202) 19.01  (2.159)
24.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week 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 were from a mixed model for repeated measurements (MMRM).
Time Frame Baseline to Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 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 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 143
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 (n=137, 143) 10.32  (1.455) 11.72  (1.470)
Week 4 (n=129, 134) 12.58  (1.610) 15.12  (1.617)
Week 8 (n=113, 125) 17.95  (1.716) 16.91  (1.686)
25.Secondary Outcome
Title Health Care 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).
Arm/Group Title Placebo Vortioxetine 5 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Overall Number of Participants Analyzed 139 136
Measure Type: Number
Unit of Measure: participants
Baseline: Any resource use 30 30
Baseline: Any hospitalization-related services 1 0
Baseline: Hospitalization related to anxiety 0 0
Baseline: Any sick leave 8 10
Baseline: Sick leave related to anxiety 7 4
Week 8: Any resource use 22 19
Week 8: Any hospitalization-related service 0 1
Week 8: Hospitalization related to anxiety 0 0
Week 8: Any sick leave 4 6
Week 8: Sick leave related to anxiety 2 1
Time Frame Safety was assessed during the 8-week core treatment period and a 4-week follow-up period.
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 5 mg
Hide Arm/Group Description Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
All-Cause Mortality
Placebo Vortioxetine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vortioxetine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/151 (1.99%)   1/148 (0.68%) 
Infections and infestations     
Prostate infection  1  1/151 (0.66%)  0/148 (0.00%) 
Injury, poisoning and procedural complications     
Therapeutic agent toxicity  1  0/151 (0.00%)  1/148 (0.68%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  2/151 (1.32%)  0/148 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 11.1.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Vortioxetine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   65/151 (43.05%)   89/148 (60.14%) 
Gastrointestinal disorders     
Nausea  1  7/151 (4.64%)  37/148 (25.00%) 
Dry mouth  1  5/151 (3.31%)  12/148 (8.11%) 
Diarrhoea  1  7/151 (4.64%)  8/148 (5.41%) 
Constipation  1  2/151 (1.32%)  5/148 (3.38%) 
Dyspepsia  1  2/151 (1.32%)  3/148 (2.03%) 
Vomiting  1  1/151 (0.66%)  3/148 (2.03%) 
General disorders     
Irritability  1  4/151 (2.65%)  2/148 (1.35%) 
Fatigue  1  3/151 (1.99%)  3/148 (2.03%) 
Infections and infestations     
Nasopharyngitis  1  6/151 (3.97%)  8/148 (5.41%) 
Upper respiratory tract infection  1  5/151 (3.31%)  3/148 (2.03%) 
Viral upper respiratory tract infection  1  5/151 (3.31%)  4/148 (2.70%) 
Gastroenteritis viral  1  0/151 (0.00%)  4/148 (2.70%) 
Injury, poisoning and procedural complications     
Overdose  1  1/151 (0.66%)  3/148 (2.03%) 
Investigations     
Blood pressure increased  1  7/151 (4.64%)  1/148 (0.68%) 
Metabolism and nutrition disorders     
Increased appetite  1  2/151 (1.32%)  5/148 (3.38%) 
Decreased appetite  1  3/151 (1.99%)  3/148 (2.03%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/151 (0.66%)  6/148 (4.05%) 
Neck pain  1  0/151 (0.00%)  3/148 (2.03%) 
Nervous system disorders     
Headache  1  13/151 (8.61%)  15/148 (10.14%) 
Dizziness  1  5/151 (3.31%)  12/148 (8.11%) 
Somnolence  1  3/151 (1.99%)  9/148 (6.08%) 
Sinus headache  1  4/151 (2.65%)  1/148 (0.68%) 
Memory impairment  1  0/151 (0.00%)  3/148 (2.03%) 
Tremor  1  1/151 (0.66%)  3/148 (2.03%) 
Psychiatric disorders     
Insomnia  1  6/151 (3.97%)  7/148 (4.73%) 
Abnormal dreams  1  4/151 (2.65%)  3/148 (2.03%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/151 (0.66%)  4/148 (2.70%) 
Vascular disorders     
Hot flush  1  0/151 (0.00%)  3/148 (2.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 11.1.
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
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00734071     History of Changes
Other Study ID Numbers: LuAA21004_310
U1111-1114-4876 ( Registry Identifier: WHO )
First Submitted: August 11, 2008
First Posted: August 13, 2008
Results First Submitted: October 25, 2013
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013