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Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients

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ClinicalTrials.gov Identifier: NCT00811252
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : December 18, 2013
Last Update Posted : January 29, 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 453
Recruitment Details Patients were mainly recruited via psychiatric, psycho-geriatric, and geriatric inpatient or outpatient settings.
Pre-assignment Details The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind down-taper period (Week 9); and a 4-week Safety Follow-up Period after completion/withdrawal (Weeks 8 to 12).
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description capsules; daily; orally encapsulated tablets; daily; orally encapsulated tablets; daily; orally
Period Title: Overall Study
Started 145 156 151
Completed 128 136 128
Not Completed 17 20 23
Reason Not Completed
Adverse Event             6             10             15
Lack of Efficacy             7             2             0
Protocol Violation             3             3             2
Withdrawal of Consent             1             2             2
Lost to Follow-up             0             0             2
Administrative or Other Reasons             0             3             2
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg Total
Hide Arm/Group Description capsules; daily; orally encapsulated tablets; daily; orally encapsulated tablets; daily; orally Total of all reporting groups
Overall Number of Baseline Participants 145 156 151 452
Hide Baseline 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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 156 participants 151 participants 452 participants
70.3  (4.4) 70.5  (4.8) 70.9  (5.5) 70.6  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 156 participants 151 participants 452 participants
Female
90
  62.1%
107
  68.6%
100
  66.2%
297
  65.7%
Male
55
  37.9%
49
  31.4%
51
  33.8%
155
  34.3%
HAM-D-24   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 156 participants 151 participants 452 participants
29.4  (5.1) 29.2  (5.0) 28.5  (4.9) 29.0  (5.0)
[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.
MADRS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 156 participants 151 participants 452 participants
30.3  (3.2) 30.7  (3.6) 30.4  (3.1) 30.5  (3.3)
[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-A   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 156 participants 151 participants 452 participants
19.5  (5.7) 19.9  (5.8) 19.2  (6.5) 19.5  (6.0)
[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.
CGI-S   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 156 participants 151 participants 452 participants
4.7  (0.7) 4.8  (0.7) 4.7  (0.8) 4.7  (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.
GDS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 145 participants 156 participants 151 participants 452 participants
7.7  (2.0) 7.4  (2.2) 7.7  (2.3) 7.6  (2.2)
[1]
Measure Description: The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.
1.Primary 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
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 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-10.3  (0.76) -13.7  (0.74) -15.8  (0.75)
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 0.05 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 0.0011
Comments Since p-value <0.05, hierarchically testing continued
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.32
Confidence Interval (2-Sided) 95%
-5.31 to -1.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.01
Estimation Comments A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 <0.0001
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 -5.48
Confidence Interval (2-Sided) 95%
-7.50 to -3.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.03
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF, ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-10.2  (0.71) -12.3  (0.69) -14.4  (0.70)
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 0.05 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 0.0240
Comments Since p-value <0.05, hierarchically testing continued
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.13
Confidence Interval (2-Sided) 95%
-3.98 to -0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.94
Estimation Comments A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 <0.0001
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 -4.22
Confidence Interval (2-Sided) 95%
-6.10 to -2.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.96
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-8.99  (0.64) -10.1  (0.62) -12.3  (0.63)
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 0.2134
Comments Since p-value >0.05, hierarchically testing stopped here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-2.72 to 0.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0002
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 -3.30
Confidence Interval (2-Sided) 95%
-4.99 to -1.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.86
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-6.66  (0.53) -6.95  (0.51) -7.91  (0.52)
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 0.6879
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.67 to 1.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.0827
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-2.65 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.72
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment
Hide Description [Not Specified]
Time Frame Baseline and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 154 147
Mean (Standard Error)
Unit of Measure: units on a scale
-3.62  (0.41) -4.04  (0.40) -3.48  (0.41)
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 0.4482
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-1.49 to 0.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
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 0.7971
Comments A nominal p-value is provided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.95 to 1.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.56
Estimation Comments [Not Specified]
6.Secondary 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
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-11.2  (0.77) -15.5  (0.75) -18.0  (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 <0.0001
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.29
Confidence Interval (2-Sided) 95%
-6.32 to -2.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.03
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF; ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-5.74  (0.55) -8.09  (0.54) -9.28  (0.54)
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 0.0015
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.35
Confidence Interval (2-Sided) 95%
-3.80 to -0.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.74
Estimation Comments [Not Specified]
8.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 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
-1.03  (0.11) -1.63  (0.10) -2.05  (0.11)
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 <0.0001
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-0.88 to -0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments [Not Specified]
9.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 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Mean (Standard Error)
Unit of Measure: units on a scale
2.91  (0.10) 2.35  (0.09) 2.07  (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 <0.0001
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-0.82 to -0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in GDS Total Score After 8 Weeks of Treatment
Hide Description The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; observed cases (OC); ANCOVA
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 144 154 142
Mean (Standard Error)
Unit of Measure: units on a scale
-0.65  (0.17) -1.08  (0.17) -1.32  (0.17)
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 0.0552
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.88 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; LOCF
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Measure Type: Number
Unit of Measure: percentage of patients
35 53 63
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 0.0008
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.26 to 0.70
Estimation Comments [Not Specified]
12.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
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 145 155 148
Measure Type: Number
Unit of Measure: percentage of patients
21 34 47
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 0.0090
Comments A nominal p-value is provided. No correction for multiplicity was made.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.47
Confidence Interval (2-Sided) 95%
0.27 to 0.83
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Risk of Suicidality Using C-SSRS Scores
Hide Description The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS)
Arm/Group Title Placebo Vortioxetine 5 mg Duloxetine 60 mg
Hide Arm/Group Description:
capsules; daily; orally
encapsulated tablets; daily; orally
encapsulated tablets; daily; orally
Overall Number of Participants Analyzed 114 121 114
Measure Type: Number
Unit of Measure: participants
No ideation or behavior 103 107 106
Completed Suicide 0 0 0
Suicide Attempt 0 0 1
Preparatory Actions Toward Imminent Suicidal Behav 0 0 0
Suicidal Ideation: Passive 8 14 7
Suicidal Ideation: Active / Nonspecific 3 0 0
Suicidal Ideation: Active / Method, but no intent 0 0 0
Suicidal Ideation: Active / Method and intent, but 0 0 0
Suicidal Ideation: Active / Method, intent, and pl 0 0 0
Self-Injurious Behavior Without Suicidal Intent 0 0 0
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 5 mg Duloxetine 60 mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Vortioxetine 5 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vortioxetine 5 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/145 (2.76%)   1/156 (0.64%)   1/151 (0.66%) 
Injury, poisoning and procedural complications       
Hip fracture * 1  1/145 (0.69%)  0/156 (0.00%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bile duct cancer * 1  1/145 (0.69%)  0/156 (0.00%)  0/151 (0.00%) 
Prostate cancer * 1  0/55 (0.00%)  0/49 (0.00%)  1/51 (1.96%) 
Nervous system disorders       
Transient ischaemic attack * 1  1/145 (0.69%)  0/156 (0.00%)  0/151 (0.00%) 
Psychiatric disorders       
Depression * 1  1/145 (0.69%)  0/156 (0.00%)  0/151 (0.00%) 
Major depression * 1  0/145 (0.00%)  1/156 (0.64%)  0/151 (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 5 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/145 (43.45%)   72/156 (46.15%)   104/151 (68.87%) 
Gastrointestinal disorders       
Constipation * 1  6/145 (4.14%)  10/156 (6.41%)  21/151 (13.91%) 
Diarrhoea * 1  10/145 (6.90%)  8/156 (5.13%)  14/151 (9.27%) 
Dry mouth * 1  7/145 (4.83%)  10/156 (6.41%)  33/151 (21.85%) 
Nausea * 1  12/145 (8.28%)  34/156 (21.79%)  50/151 (33.11%) 
General disorders       
Fatigue * 1  5/145 (3.45%)  11/156 (7.05%)  16/151 (10.60%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  2/145 (1.38%)  7/156 (4.49%)  8/151 (5.30%) 
Nervous system disorders       
Dizziness * 1  10/145 (6.90%)  14/156 (8.97%)  14/151 (9.27%) 
Headache * 1  25/145 (17.24%)  18/156 (11.54%)  18/151 (11.92%) 
Somnolence * 1  3/145 (2.07%)  4/156 (2.56%)  16/151 (10.60%) 
Reproductive system and breast disorders       
Ejaculation delayed * 1  0/55 (0.00%)  0/49 (0.00%)  3/51 (5.88%) 
Erectile dysfunction * 1  0/55 (0.00%)  0/49 (0.00%)  3/51 (5.88%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis * 1  4/145 (2.76%)  6/156 (3.85%)  16/151 (10.60%) 
*
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: NCT00811252     History of Changes
Other Study ID Numbers: 12541A
2008-002901-38 ( EudraCT Number )
First Submitted: December 17, 2008
First Posted: December 18, 2008
Results First Submitted: October 28, 2013
Results First Posted: December 18, 2013
Last Update Posted: January 29, 2014