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Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of 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: NCT00635219
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Placebo
Drug: Vortioxetine (Lu AA21004)
Drug: Duloxetine
Enrollment 766
Recruitment Details The patients were recruited from psychiatric settings.
Pre-assignment Details The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind downtaper period (Week 9); and a 4-week Safety Follow-up Period - the 4-week period after completion/withdrawal (Weeks 9 to 12).
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description capsules; daily; orally encapsulated tablets; orally encapsulated tablets; orally encapsulated tablets; orally encapsulated capsules; orally
Period Title: Overall Study
Started 148 155 157 151 155
Completed 123 130 122 117 113
Not Completed 25 25 35 34 42
Reason Not Completed
Adverse Event             12             10             18             15             19
Lack of Efficacy             5             6             3             4             6
Non-compliance With Study Product             0             0             0             2             1
Protocol Violation             0             2             3             2             4
Withdrawal of Consent             8             6             8             11             8
Lost to Follow-up             0             0             2             0             3
Administrative or Other Reasons             0             1             1             0             1
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg Total
Hide Arm/Group Description capsules; daily; orally encapsulated tablets; orally encapsulated tablets; orally encapsulated tablets; orally encapsulated capsules; orally Total of all reporting groups
Overall Number of Baseline Participants 148 155 157 151 155 766
Hide Baseline Analysis Population Description
Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid postbaseline assessment of the primary efficacy variable
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
43.4  (12.5) 46.0  (12.5) 44.7  (13.1) 45.2  (13.1) 45.3  (12.0) 44.9  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
Female
103
  69.6%
110
  71.0%
104
  66.2%
100
  66.2%
105
  67.7%
522
  68.1%
Male
45
  30.4%
45
  29.0%
53
  33.8%
51
  33.8%
50
  32.3%
244
  31.9%
MADRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
31.7  (4.3) 31.6  (4.0) 32.7  (4.8) 31.8  (3.9) 31.4  (4.2) 31.9  (4.3)
[1]
Measure Description: The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
HAM-D-24   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
29.8  (5.1) 29.6  (5.8) 31.3  (5.8) 30.4  (5.4) 29.9  (5.8) 30.2  (5.6)
[1]
Measure Description: The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
CGI-S   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
4.8  (0.7) 4.8  (0.7) 4.8  (0.7) 4.7  (0.7) 4.7  (0.7) 4.8  (0.7)
[1]
Measure Description: The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
SDS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
19.9  (5.8) 19.4  (6.5) 19.6  (6.2) 19.6  (6.5) 19.2  (5.9) 19.6  (6.2)
[1]
Measure Description: The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
HAM-A   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 148 participants 155 participants 157 participants 151 participants 155 participants 766 participants
23.1  (5.6) 22.2  (6.7) 23.5  (6.2) 23.4  (6.3) 22.8  (6.4) 23.0  (6.3)
[1]
Measure Description: The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour 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 score from 0 to 56. The higher the score, the more severe.
1.Primary Outcome
Title Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
Hide Description The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 155 155 151 149
Mean (Standard Error)
Unit of Measure: units on a scale
-14.8  (0.82) -16.2  (0.79) -16.5  (0.80) -16.3  (0.80) -16.8  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1321
Comments Since p-value >0.025, hierarchically testing stopped here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-3.92 to 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.13
Estimation Comments To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 10 mg
Comments As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1847
Comments Since p-value >0.025, hierarchically testing stopped here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.50
Confidence Interval (2-Sided) 95%
-3.73 to 0.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.13
Estimation Comments To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2187
Comments This dose was not in the testing sequence. A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-3.59 to 0.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0741
Comments This treatment arm was not in the testing sequence. A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.04
Confidence Interval (2-Sided) 95%
-4.27 to 0.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
Hide Description The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 155 155 151 149
Mean (Standard Error)
Unit of Measure: units on a scale
-13.3  (0.82) -14.4  (0.79) -15.0  (0.80) -14.9  (0.80) -15.7  (0.81)
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 0.1120
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.79
Confidence Interval (2-Sided) 95%
-4.01 to 0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.13
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.1487
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.63
Confidence Interval (2-Sided) 95%
-3.85 to 0.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.13
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3246
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-3.31 to 1.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.12
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0298
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.47
Confidence Interval (2-Sided) 95%
-4.70 to -0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.13
Estimation Comments No correction for multiplicity was made.
3.Secondary Outcome
Title Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; Logistic Regression
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 155 155 151 149
Measure Type: Number
Unit of Measure: percentage of patients
46.9 54.2 56.1 57.6 57.1
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 0.1370
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
0.90 to 2.23
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0664
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
0.97 to 2.43
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2023
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.85 to 2.12
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0765
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.96 to 2.40
Estimation Comments No correction for multiplicity was made.
4.Secondary Outcome
Title Change in Clinical Status Using CGI-I Score at Week 8
Hide Description The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 155 154 151 149
Mean (Standard Error)
Unit of Measure: units on a scale
2.52  (0.10) 2.32  (0.10) 2.32  (0.10) 2.35  (0.10) 2.31  (0.10)
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 0.1436
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.47 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.2114
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.44 to 0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1389
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.47 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1271
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.48 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments No correction for multiplicity was made.
5.Secondary Outcome
Title Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20
Hide Description [Not Specified]
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Patients With Baseline HAM-A Total Score >=20: FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 97 91 100 101 92
Mean (Standard Error)
Unit of Measure: units on a scale
-14.7  (1.10) -14.3  (1.15) -15.8  (1.09) -15.8  (1.07) -17.3  (1.14)
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 0.4421
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-4.08 to 1.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.49
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.4399
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-4.07 to 1.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.49
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8093
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-2.65 to 3.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.54
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0897
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.60
Confidence Interval (2-Sided) 95%
-5.61 to 0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.53
Estimation Comments No correction for multiplicity was made.
6.Secondary Outcome
Title Change From Baseline in SDS Total Score After 8 Weeks of Treatment
Hide Description The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 116 115 119 115 108
Mean (Standard Error)
Unit of Measure: units on a scale
-6.11  (0.72) -7.10  (0.74) -6.52  (0.73) -7.81  (0.74) -7.91  (0.76)
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 0.6748
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-2.35 to 1.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.98
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0871
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-3.64 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.99
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3186
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-2.94 to 0.96
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.99
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0768
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-3.79 to 0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.01
Estimation Comments No correction for multiplicity was made.
7.Secondary Outcome
Title Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; Logistic Regression
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 155 155 151 149
Measure Type: Number
Unit of Measure: percentage of patients
33.8 32.9 36.1 35.8 34.9
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 0.6258
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.70 to 1.81
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.7178
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.68 to 1.76
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8651
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.59 to 1.55
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8563
Comments A nominal p-value is provided.
Method Adjusting for Baseline
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.65 to 1.69
Estimation Comments No correction for multiplicity was made.
8.Secondary Outcome
Title Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
Hide Description The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour 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 score from 0 to 56. The higher the score, the more severe.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 154 155 151 148
Mean (Standard Error)
Unit of Measure: units on a scale
-9.57  (0.63) -9.87  (0.61) -10.7  (0.61) -10.6  (0.62) -11.0  (0.62)
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 0.1925
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-2.82 to 0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.86
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.2434
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-2.72 to 0.69
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7246
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-2.00 to 1.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.86
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0981
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-3.16 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments No correction for multiplicity was made.
9.Secondary Outcome
Title Change From Baseline in CGI-S Score After 8 Weeks of Treatment
Hide Description The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 145 155 154 151 149
Mean (Standard Error)
Unit of Measure: units on a scale
-1.64  (0.11) -1.83  (0.10) -1.81  (0.10) -1.83  (0.10) -1.82  (0.10)
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 0.2285
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.46 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.1794
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.48 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1741
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.48 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2247
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.46 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments No correction for multiplicity was made.
10.Secondary Outcome
Title Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
Hide Description The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated tablets; orally
encapsulated capsules; orally
Overall Number of Participants Analyzed 74 77 76 75 72
Mean (Standard Error)
Unit of Measure: units on a scale
-0.41  (0.65) -0.53  (0.62) -0.66  (0.64) -0.62  (0.62) -0.38  (0.64)
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 0.7789
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-1.93 to 1.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.86
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.8121
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-1.91 to 1.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8918
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-1.82 to 1.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments No correction for multiplicity was made.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duloxetine 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9720
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-1.69 to 1.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.87
Estimation Comments No correction for multiplicity was made.
Time Frame Serious Adverse Events: 8-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 8-week double-blind treatment period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/148 (2.03%)   1/155 (0.65%)   3/157 (1.91%)   2/151 (1.32%)   2/155 (1.29%) 
Ear and labyrinth disorders           
Middle ear effusion * 1  0/148 (0.00%)  0/155 (0.00%)  0/157 (0.00%)  0/151 (0.00%)  1/155 (0.65%) 
Hepatobiliary disorders           
Jaundice cholestatic * 1  0/148 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/151 (0.00%)  0/155 (0.00%) 
Injury, poisoning and procedural complications           
Pelvic fracture * 1  0/148 (0.00%)  0/155 (0.00%)  0/157 (0.00%)  1/151 (0.66%)  0/155 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Gallbladder cancer * 1  0/148 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/151 (0.00%)  0/155 (0.00%) 
Nervous system disorders           
Serotonin syndrome * 1  1/148 (0.68%)  0/155 (0.00%)  0/157 (0.00%)  0/151 (0.00%)  1/155 (0.65%) 
Psychiatric disorders           
Depression * 1  0/148 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  1/151 (0.66%)  0/155 (0.00%) 
Suicidal ideation * 1  0/148 (0.00%)  1/155 (0.65%)  0/157 (0.00%)  0/151 (0.00%)  0/155 (0.00%) 
Suicide attempt * 1  0/148 (0.00%)  0/155 (0.00%)  1/157 (0.64%)  0/151 (0.00%)  0/155 (0.00%) 
Reproductive system and breast disorders           
Adenomyosis * 1  1/103 (0.97%)  0/110 (0.00%)  0/104 (0.00%)  0/100 (0.00%)  0/105 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism * 1  1/148 (0.68%)  0/155 (0.00%)  0/157 (0.00%)  0/151 (0.00%)  0/155 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDDRA12_1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Vortioxetine 2.5 mg Vortioxetine 5 mg Vortioxetine 10 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   64/148 (43.24%)   61/155 (39.35%)   63/157 (40.13%)   62/151 (41.06%)   93/155 (60.00%) 
Gastrointestinal disorders           
Constipation * 1  6/148 (4.05%)  3/155 (1.94%)  5/157 (3.18%)  3/151 (1.99%)  10/155 (6.45%) 
Diarrhoea * 1  10/148 (6.76%)  7/155 (4.52%)  3/157 (1.91%)  8/151 (5.30%)  7/155 (4.52%) 
Dry mouth * 1  11/148 (7.43%)  6/155 (3.87%)  9/157 (5.73%)  6/151 (3.97%)  12/155 (7.74%) 
Nausea * 1  13/148 (8.78%)  26/155 (16.77%)  26/157 (16.56%)  33/151 (21.85%)  52/155 (33.55%) 
Vomiting * 1  5/148 (3.38%)  6/155 (3.87%)  6/157 (3.82%)  7/151 (4.64%)  11/155 (7.10%) 
General disorders           
Fatigue * 1  3/148 (2.03%)  1/155 (0.65%)  3/157 (1.91%)  3/151 (1.99%)  8/155 (5.16%) 
Infections and infestations           
Nasopharyngitis * 1  6/148 (4.05%)  12/155 (7.74%)  11/157 (7.01%)  4/151 (2.65%)  3/155 (1.94%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  2/148 (1.35%)  0/155 (0.00%)  2/157 (1.27%)  1/151 (0.66%)  12/155 (7.74%) 
Nervous system disorders           
Dizziness * 1  10/148 (6.76%)  7/155 (4.52%)  5/157 (3.18%)  6/151 (3.97%)  25/155 (16.13%) 
Headache * 1  24/148 (16.22%)  22/155 (14.19%)  16/157 (10.19%)  19/151 (12.58%)  22/155 (14.19%) 
Somnolence * 1  5/148 (3.38%)  5/155 (3.23%)  4/157 (2.55%)  5/151 (3.31%)  11/155 (7.10%) 
Psychiatric disorders           
Insomnia * 1  6/148 (4.05%)  8/155 (5.16%)  11/157 (7.01%)  3/151 (1.99%)  13/155 (8.39%) 
Skin and subcutaneous tissue disorders           
Hyperhidrosis * 1  1/148 (0.68%)  1/155 (0.65%)  4/157 (2.55%)  3/151 (1.99%)  10/155 (6.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MEDDRA12_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 main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.
Results Point of Contact
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
Phone: +45 3630 1311
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00635219     History of Changes
Other Study ID Numbers: 11984A
EudraCT 2007-001870-95 ( Registry Identifier: EudraCT )
First Submitted: March 3, 2008
First Posted: March 13, 2008
Results First Submitted: October 28, 2013
Results First Posted: February 11, 2014
Last Update Posted: February 11, 2014