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Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01255787
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Drug: Vortioxetine
Drug: Placebo
Enrollment 600

Recruitment Details Participants took part in the study at 90 investigative sites in Japan, Europe and Asia/Oceania from 18 November 2010 to 25 April 2012.
Pre-assignment Details Participants with a diagnosis of major depressive disorder were enrolled equally in 1 of 4 treatment groups, once a day placebo, 5 mg, 10 mg, or 20 mg vortioxetine.
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Period Title: Overall Study
Started 152 144 150 154
Treated 152 144 148 150
Completed 136 127 132 132
Not Completed 16 17 18 22
Reason Not Completed
Pretreatment Event or Adverse Event (AE)             6             2             9             9
Major Protocol Deviation             1             1             0             4
Lost to Follow-up             1             2             4             2
Withdrawal of Consent             3             9             3             4
Pregnancy             0             0             0             1
Lack of Efficacy             2             2             2             2
Noncompliance with Study Drug             3             1             0             0
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg Total
Hide Arm/Group Description Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 152 144 150 154 600
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
43.6  (11.57) 44.2  (11.89) 45.7  (10.90) 44.0  (11.79) 44.4  (11.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Female
91
  59.9%
98
  68.1%
93
  62.0%
93
  60.4%
375
  62.5%
Male
61
  40.1%
46
  31.9%
57
  38.0%
61
  39.6%
225
  37.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Caucasian (or White, including Hispanic) 104 101 104 105 414
Asian 48 43 46 49 186
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Croatia 0 1 0 2 3
Finland 5 5 5 5 20
Germany 50 50 50 49 199
India 3 3 3 2 11
Japan 33 32 31 33 129
Latvia 3 2 2 3 10
Malaysia 2 0 0 2 4
Philippines 4 2 4 3 13
Poland 20 18 20 21 79
Romania 5 4 6 3 18
Russia 13 13 12 13 51
Serbia 2 2 3 2 9
South Korea 6 6 7 8 27
Ukraine 6 6 7 8 27
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
167.1  (8.75) 167.2  (9.64) 167.5  (9.40) 167.5  (9.61) 167.3  (9.33)
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
69.70  (16.901) 70.57  (18.214) 73.37  (19.014) 70.21  (18.189) 70.95  (18.095)
[1]
Measure Description: Number of participants for whom weight data were available were 152, 144, 147 and 149 in each treatment group respectively.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
24.82  (5.129) 25.06  (5.432) 25.93  (5.462) 24.82  (5.206) 25.15  (5.313)
[1]
Measure Description: Number of participants for whom BMI data were available were 152, 144, 147 and 149 in each treatment group respectively.
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Current smoker 51 50 50 56 207
Ex-smoker 22 19 21 11 73
Never smoked 79 75 79 87 320
History of Alcohol Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Never 58 62 54 56 230
Once monthly or less often 52 41 54 53 200
Once a week 17 22 22 22 83
2 to 6 times per week 14 9 10 13 46
Daily 11 10 10 10 41
Status of Major Depressive Episode (MDE)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Single episode 51 55 49 49 204
Recurrent episode 101 89 101 105 396
[1]
Measure Description: An MDE is a period marked by depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration.
Pharmacotherapy for Current Major Depressive Episode  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
Yes 73 60 69 75 277
No 79 84 81 79 323
Montgomery Åsberg Depression Rating Scale (MADRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
31.6  (3.56) 31.6  (3.67) 31.8  (4.02) 31.7  (3.73) 31.7  (3.74)
[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).

Number of participants for whom MADRS data were available were 152, 144, 147 and 149 in each treatment arm respectively.

Clinical Global Impression - Severity scale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
4.7  (0.66) 4.7  (0.65) 4.7  (0.66) 4.7  (0.65) 4.70  (0.65)
[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. Number of participants for whom CGI-S data were available were 152, 144, 147 and 149 in each treatment arm respectively.
Sheehan Disability Scale (SDS) - Total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
18.2  (5.28) 17.9  (6.27) 18.5  (5.42) 18.2  (5.70) 18.2  (5.65)
[1]
Measure 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. Number of participants for whom SDS data were available were 132, 116, 119 and 121 in each treatment arm respectively.
Hamilton Anxiety Scale Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 152 participants 144 participants 150 participants 154 participants 600 participants
18.6  (6.83) 18.9  (6.55) 18.8  (6.66) 18.5  (6.12) 18.7  (6.53)
[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). Number of participants for whom HAM-A data were available were 152, 144, 148 and 150 in each treatment arm respectively.
1.Primary Outcome
Title Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used.
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Overall Number of Participants Analyzed 150 142 147 149
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-13.99  (0.783) -14.61  (0.805) -15.68  (0.791) -15.82  (0.786)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 5 mg
Comments All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9070
Comments Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.
Method ANCOVA
Comments Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-3.258 to 2.035
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.123
Estimation Comments [Not Specified]
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 0.3006
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.69
Confidence Interval (2-Sided) 95%
-4.310 to 0.938
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.114
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vortioxetine 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2399
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.82
Confidence Interval (2-Sided) 95%
-4.436 to 0.794
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.110
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a MADRS Response at Week 8
Hide Description Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Overall Number of Participants Analyzed 150 142 147 149
Measure Type: Number
Unit of Measure: percentage of participants
39.3 49.3 54.4 51.0
3.Secondary Outcome
Title Percentage of Participants in MADRS Remission at Week 8
Hide Description Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Overall Number of Participants Analyzed 150 142 147 149
Measure Type: Number
Unit of Measure: percentage of participants
26.7 24.6 29.3 30.9
4.Secondary Outcome
Title Mean Clinical Global Impression Scale - Improvement (CGI-I) Score 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 an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Overall Number of Participants Analyzed 150 142 148 150
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
2.54  (0.087) 2.37  (0.089) 2.27  (0.088) 2.36  (0.087)
5.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 family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.
Time Frame Baseline and Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description:
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Overall Number of Participants Analyzed 126 109 114 118
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-6.20  (0.602) -6.38  (0.647) -7.97  (0.633) -7.26  (0.622)
Time Frame A treatment-emergent adverse event is defined as any AE whose onset occurs or intensity increases after the first dose of double-blind study medication through 2 weeks after the last dose of double-blind study medication.
Adverse Event Reporting Description The safety analysis set included all patients who received at least 1 dose of study drug. One patient in the placebo arm was excluded due to enrollment in another clinical study. Any event spontaneously reported by the patient or observed by the investigator was recorded, irrespective of relation to study drug.
 
Arm/Group Title Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Hide Arm/Group Description Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
All-Cause Mortality
Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/151 (0.66%)   2/144 (1.39%)   2/148 (1.35%)   3/150 (2.00%) 
Infections and infestations         
Gastroenteritis  1  0/151 (0.00%)  0/144 (0.00%)  1/148 (0.68%)  0/150 (0.00%) 
Pyelonephritis  1  0/151 (0.00%)  0/144 (0.00%)  0/148 (0.00%)  1/150 (0.67%) 
Nervous system disorders         
Syncope  1  0/151 (0.00%)  1/144 (0.69%)  0/148 (0.00%)  0/150 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion missed  1  0/151 (0.00%)  0/144 (0.00%)  0/148 (0.00%)  1/150 (0.67%) 
Psychiatric disorders         
Suicide attempt  1  1/151 (0.66%)  0/144 (0.00%)  0/148 (0.00%)  1/150 (0.67%) 
Depression  1  0/151 (0.00%)  0/144 (0.00%)  1/148 (0.68%)  0/150 (0.00%) 
Suicidal ideation  1  0/151 (0.00%)  0/144 (0.00%)  0/148 (0.00%)  1/150 (0.67%) 
Renal and urinary disorders         
Renal colic  1  0/151 (0.00%)  1/144 (0.69%)  0/148 (0.00%)  0/150 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Vortioxetine 5 mg Vortioxetine 10 mg Vortioxetine 20 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   97/151 (64.24%)   96/144 (66.67%)   93/148 (62.84%)   106/150 (70.67%) 
Cardiac disorders         
Palpitations  1  2/151 (1.32%)  0/144 (0.00%)  0/148 (0.00%)  3/150 (2.00%) 
Ear and labyrinth disorders         
Tinnitus  1  3/151 (1.99%)  2/144 (1.39%)  1/148 (0.68%)  3/150 (2.00%) 
Vertigo  1  3/151 (1.99%)  1/144 (0.69%)  2/148 (1.35%)  3/150 (2.00%) 
Gastrointestinal disorders         
Nausea  1  11/151 (7.28%)  26/144 (18.06%)  27/148 (18.24%)  37/150 (24.67%) 
Diarrhoea  1  14/151 (9.27%)  7/144 (4.86%)  6/148 (4.05%)  5/150 (3.33%) 
Constipation  1  3/151 (1.99%)  6/144 (4.17%)  5/148 (3.38%)  8/150 (5.33%) 
Dry mouth  1  3/151 (1.99%)  3/144 (2.08%)  6/148 (4.05%)  9/150 (6.00%) 
Vomiting  1  3/151 (1.99%)  2/144 (1.39%)  1/148 (0.68%)  6/150 (4.00%) 
Abdominal pain upper  1  4/151 (2.65%)  2/144 (1.39%)  2/148 (1.35%)  3/150 (2.00%) 
Dyspepsia  1  0/151 (0.00%)  3/144 (2.08%)  3/148 (2.03%)  4/150 (2.67%) 
Abdominal discomfort  1  0/151 (0.00%)  2/144 (1.39%)  1/148 (0.68%)  3/150 (2.00%) 
Abdominal pain  1  3/151 (1.99%)  2/144 (1.39%)  1/148 (0.68%)  0/150 (0.00%) 
Abdominal distension  1  0/151 (0.00%)  3/144 (2.08%)  1/148 (0.68%)  0/150 (0.00%) 
General disorders         
Fatigue  1  2/151 (1.32%)  6/144 (4.17%)  4/148 (2.70%)  5/150 (3.33%) 
Thirst  1  1/151 (0.66%)  0/144 (0.00%)  3/148 (2.03%)  0/150 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal  1  0/151 (0.00%)  0/144 (0.00%)  3/148 (2.03%)  0/150 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  18/151 (11.92%)  24/144 (16.67%)  18/148 (12.16%)  21/150 (14.00%) 
Bronchitis  1  3/151 (1.99%)  1/144 (0.69%)  1/148 (0.68%)  1/150 (0.67%) 
Respiratory tract infection  1  0/151 (0.00%)  3/144 (2.08%)  0/148 (0.00%)  1/150 (0.67%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/151 (0.66%)  4/144 (2.78%)  0/148 (0.00%)  1/150 (0.67%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  3/151 (1.99%)  2/144 (1.39%)  6/148 (4.05%)  1/150 (0.67%) 
Arthralgia  1  1/151 (0.66%)  3/144 (2.08%)  0/148 (0.00%)  0/150 (0.00%) 
Pain in extremity  1  0/151 (0.00%)  0/144 (0.00%)  3/148 (2.03%)  1/150 (0.67%) 
Nervous system disorders         
Headache  1  21/151 (13.91%)  16/144 (11.11%)  19/148 (12.84%)  23/150 (15.33%) 
Dizziness  1  5/151 (3.31%)  7/144 (4.86%)  8/148 (5.41%)  10/150 (6.67%) 
Hypoaesthesia  1  4/151 (2.65%)  1/144 (0.69%)  1/148 (0.68%)  1/150 (0.67%) 
Sedation  1  1/151 (0.66%)  2/144 (1.39%)  0/148 (0.00%)  3/150 (2.00%) 
Somnolence  1  2/151 (1.32%)  7/144 (4.86%)  7/148 (4.73%)  6/150 (4.00%) 
Psychiatric disorders         
Insomnia  1  2/151 (1.32%)  4/144 (2.78%)  4/148 (2.70%)  9/150 (6.00%) 
Suicidal ideation  1  4/151 (2.65%)  2/144 (1.39%)  2/148 (1.35%)  2/150 (1.33%) 
Depression  1  3/151 (1.99%)  1/144 (0.69%)  2/148 (1.35%)  1/150 (0.67%) 
Libido decreased  1  0/151 (0.00%)  0/144 (0.00%)  0/148 (0.00%)  3/150 (2.00%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  0/151 (0.00%)  3/144 (2.08%)  0/148 (0.00%)  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/151 (0.00%)  1/144 (0.69%)  0/148 (0.00%)  3/150 (2.00%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  2/151 (1.32%)  5/144 (3.47%)  4/148 (2.70%)  3/150 (2.00%) 
Pruritus generalised  1  0/151 (0.00%)  0/144 (0.00%)  2/148 (1.35%)  3/150 (2.00%) 
Vascular disorders         
Hypertension  1  0/151 (0.00%)  0/144 (0.00%)  0/148 (0.00%)  3/150 (2.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01255787     History of Changes
Other Study ID Numbers: LuAA21004/CCT-002
2010-022257-41 ( EudraCT Number )
U1111-1117-6595 ( Registry Identifier: WHO )
JapicCTI-101344 ( Registry Identifier: JapicCTI )
CTRI/2011/08/001963 ( Registry Identifier: CTRI )
First Submitted: December 6, 2010
First Posted: December 7, 2010
Results First Submitted: October 25, 2013
Results First Posted: December 18, 2013
Last Update Posted: December 18, 2013