Trial Outcomes & Findings for 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 (NCT NCT00635219)
NCT ID: NCT00635219
Last Updated: 2014-02-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
766 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2014-02-11
Participant Flow
The patients were recruited from psychiatric settings.
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).
Participant milestones
| Measure |
Placebo
capsules; daily; orally
|
Vortioxetine 2.5 mg
encapsulated tablets; orally
|
Vortioxetine 5 mg
encapsulated tablets; orally
|
Vortioxetine 10 mg
encapsulated tablets; orally
|
Duloxetine 60 mg
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
148
|
155
|
157
|
151
|
155
|
|
Overall Study
COMPLETED
|
123
|
130
|
122
|
117
|
113
|
|
Overall Study
NOT COMPLETED
|
25
|
25
|
35
|
34
|
42
|
Reasons for withdrawal
| Measure |
Placebo
capsules; daily; orally
|
Vortioxetine 2.5 mg
encapsulated tablets; orally
|
Vortioxetine 5 mg
encapsulated tablets; orally
|
Vortioxetine 10 mg
encapsulated tablets; orally
|
Duloxetine 60 mg
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
10
|
18
|
15
|
19
|
|
Overall Study
Lack of Efficacy
|
5
|
6
|
3
|
4
|
6
|
|
Overall Study
Non-compliance With Study Product
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
3
|
2
|
4
|
|
Overall Study
Withdrawal of Consent
|
8
|
6
|
8
|
11
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
3
|
|
Overall Study
Administrative or Other Reasons
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=148 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=157 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=155 Participants
encapsulated capsules; orally
|
Total
n=766 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
45.3 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
44.9 years
STANDARD_DEVIATION 12.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
522 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
244 Participants
n=8 Participants
|
|
MADRS
|
31.7 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
31.6 units on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
32.7 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
31.8 units on a scale
STANDARD_DEVIATION 3.9 • n=4 Participants
|
31.4 units on a scale
STANDARD_DEVIATION 4.2 • n=21 Participants
|
31.9 units on a scale
STANDARD_DEVIATION 4.3 • n=8 Participants
|
|
HAM-D-24
|
29.8 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
29.6 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
31.3 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 5.4 • n=4 Participants
|
29.9 units on a scale
STANDARD_DEVIATION 5.8 • n=21 Participants
|
30.2 units on a scale
STANDARD_DEVIATION 5.6 • n=8 Participants
|
|
CGI-S
|
4.8 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.7 • n=4 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 0.7 • n=21 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.7 • n=8 Participants
|
|
SDS
|
19.9 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
19.4 units on a scale
STANDARD_DEVIATION 6.5 • n=7 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 6.5 • n=4 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 5.9 • n=21 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 6.2 • n=8 Participants
|
|
HAM-A
|
23.1 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
23.4 units on a scale
STANDARD_DEVIATION 6.3 • n=4 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 6.4 • n=21 Participants
|
23.0 units on a scale
STANDARD_DEVIATION 6.3 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: 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)
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=149 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
|
-14.8 units on a scale
Standard Error 0.82
|
-16.2 units on a scale
Standard Error 0.79
|
-16.5 units on a scale
Standard Error 0.80
|
-16.3 units on a scale
Standard Error 0.80
|
-16.8 units on a scale
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS; LOCF; ANCOVA
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=149 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment
|
-13.3 units on a scale
Standard Error 0.82
|
-14.4 units on a scale
Standard Error 0.79
|
-15.0 units on a scale
Standard Error 0.80
|
-14.9 units on a scale
Standard Error 0.80
|
-15.7 units on a scale
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Week 8Population: FAS; LOCF; Logistic Regression
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=149 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
|
46.9 percentage of patients
|
54.2 percentage of patients
|
56.1 percentage of patients
|
57.6 percentage of patients
|
57.1 percentage of patients
|
SECONDARY outcome
Timeframe: Week 8Population: FAS; LOCF; ANCOVA
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=154 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=149 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change in Clinical Status Using CGI-I Score at Week 8
|
2.52 units on a scale
Standard Error 0.10
|
2.32 units on a scale
Standard Error 0.10
|
2.32 units on a scale
Standard Error 0.10
|
2.35 units on a scale
Standard Error 0.10
|
2.31 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Patients With Baseline HAM-A Total Score \>=20: FAS; LOCF; ANCOVA
Outcome measures
| Measure |
Placebo
n=97 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=91 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=100 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=101 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=92 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20
|
-14.7 units on a scale
Standard Error 1.10
|
-14.3 units on a scale
Standard Error 1.15
|
-15.8 units on a scale
Standard Error 1.09
|
-15.8 units on a scale
Standard Error 1.07
|
-17.3 units on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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
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.
Outcome measures
| Measure |
Placebo
n=116 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=115 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=119 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=115 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=108 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in SDS Total Score After 8 Weeks of Treatment
|
-6.11 units on a scale
Standard Error 0.72
|
-7.10 units on a scale
Standard Error 0.74
|
-6.52 units on a scale
Standard Error 0.73
|
-7.81 units on a scale
Standard Error 0.74
|
-7.91 units on a scale
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Week 8Population: FAS; LOCF; Logistic Regression
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=149 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)
|
33.8 percentage of patients
|
32.9 percentage of patients
|
36.1 percentage of patients
|
35.8 percentage of patients
|
34.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS; LOCF; ANCOVA
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=154 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=148 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment
|
-9.57 units on a scale
Standard Error 0.63
|
-9.87 units on a scale
Standard Error 0.61
|
-10.7 units on a scale
Standard Error 0.61
|
-10.6 units on a scale
Standard Error 0.62
|
-11.0 units on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS; LOCF; ANCOVA
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.
Outcome measures
| Measure |
Placebo
n=145 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=155 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=154 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=151 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=149 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in CGI-S Score After 8 Weeks of Treatment
|
-1.64 units on a scale
Standard Error 0.11
|
-1.83 units on a scale
Standard Error 0.10
|
-1.81 units on a scale
Standard Error 0.10
|
-1.83 units on a scale
Standard Error 0.10
|
-1.82 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS; LOCF; ANCOVA
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.
Outcome measures
| Measure |
Placebo
n=74 Participants
capsules; daily; orally
|
Vortioxetine 2.5 mg
n=77 Participants
encapsulated tablets; orally
|
Vortioxetine 5 mg
n=76 Participants
encapsulated tablets; orally
|
Vortioxetine 10 mg
n=75 Participants
encapsulated tablets; orally
|
Duloxetine 60 mg
n=72 Participants
encapsulated capsules; orally
|
|---|---|---|---|---|---|
|
Change From Baseline in ASEX Total Score After 8 Weeks of Treatment
|
-0.41 units on a scale
Standard Error 0.65
|
-0.53 units on a scale
Standard Error 0.62
|
-0.66 units on a scale
Standard Error 0.64
|
-0.62 units on a scale
Standard Error 0.62
|
-0.38 units on a scale
Standard Error 0.64
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Vortioxetine 2.5 mg
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Vortioxetine 5 mg
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Vortioxetine 10 mg
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Duloxetine 60 mg
Serious events: 2 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=148 participants at risk
|
Vortioxetine 2.5 mg
n=155 participants at risk
|
Vortioxetine 5 mg
n=157 participants at risk
|
Vortioxetine 10 mg
n=151 participants at risk
|
Duloxetine 60 mg
n=155 participants at risk
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/148 • 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
|
0.00%
0/155 • 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
|
0.00%
0/157 • 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
|
0.00%
0/151 • 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
|
0.65%
1/155 • 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
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/148 • 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
|
0.00%
0/155 • 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
|
0.64%
1/157 • 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
|
0.00%
0/151 • 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
|
0.00%
0/155 • 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
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/148 • 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
|
0.00%
0/155 • 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
|
0.00%
0/157 • 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
|
0.66%
1/151 • 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
|
0.00%
0/155 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/148 • 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
|
0.00%
0/155 • 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
|
0.64%
1/157 • 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
|
0.00%
0/151 • 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
|
0.00%
0/155 • 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
|
|
Nervous system disorders
Serotonin syndrome
|
0.68%
1/148 • 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
|
0.00%
0/155 • 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
|
0.00%
0/157 • 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
|
0.00%
0/151 • 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
|
0.65%
1/155 • 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
|
|
Psychiatric disorders
Depression
|
0.00%
0/148 • 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
|
0.00%
0/155 • 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
|
0.64%
1/157 • 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
|
0.66%
1/151 • 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
|
0.00%
0/155 • 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
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/148 • 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
|
0.65%
1/155 • 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
|
0.00%
0/157 • 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
|
0.00%
0/151 • 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
|
0.00%
0/155 • 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
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/148 • 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
|
0.00%
0/155 • 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
|
0.64%
1/157 • 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
|
0.00%
0/151 • 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
|
0.00%
0/155 • 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
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.97%
1/103 • 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
|
0.00%
0/110 • 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
|
0.00%
0/104 • 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
|
0.00%
0/100 • 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
|
0.00%
0/105 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.68%
1/148 • 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
|
0.00%
0/155 • 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
|
0.00%
0/157 • 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
|
0.00%
0/151 • 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
|
0.00%
0/155 • 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
|
Other adverse events
| Measure |
Placebo
n=148 participants at risk
|
Vortioxetine 2.5 mg
n=155 participants at risk
|
Vortioxetine 5 mg
n=157 participants at risk
|
Vortioxetine 10 mg
n=151 participants at risk
|
Duloxetine 60 mg
n=155 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.1%
6/148 • 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
|
1.9%
3/155 • 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
|
3.2%
5/157 • 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
|
2.0%
3/151 • 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
|
6.5%
10/155 • 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
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
10/148 • 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
|
4.5%
7/155 • 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
|
1.9%
3/157 • 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
|
5.3%
8/151 • 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
|
4.5%
7/155 • 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
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
11/148 • 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
|
3.9%
6/155 • 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
|
5.7%
9/157 • 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
|
4.0%
6/151 • 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
|
7.7%
12/155 • 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
|
|
Gastrointestinal disorders
Nausea
|
8.8%
13/148 • 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
|
16.8%
26/155 • 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
|
16.6%
26/157 • 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
|
21.9%
33/151 • 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
|
33.5%
52/155 • 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
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
5/148 • 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
|
3.9%
6/155 • 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
|
3.8%
6/157 • 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
|
4.6%
7/151 • 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
|
7.1%
11/155 • 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
|
|
General disorders
Fatigue
|
2.0%
3/148 • 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
|
0.65%
1/155 • 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
|
1.9%
3/157 • 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
|
2.0%
3/151 • 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
|
5.2%
8/155 • 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
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
6/148 • 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
|
7.7%
12/155 • 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
|
7.0%
11/157 • 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
|
2.6%
4/151 • 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
|
1.9%
3/155 • 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
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
2/148 • 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
|
0.00%
0/155 • 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
|
1.3%
2/157 • 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
|
0.66%
1/151 • 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
|
7.7%
12/155 • 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
|
|
Nervous system disorders
Dizziness
|
6.8%
10/148 • 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
|
4.5%
7/155 • 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
|
3.2%
5/157 • 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
|
4.0%
6/151 • 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
|
16.1%
25/155 • 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
|
|
Nervous system disorders
Headache
|
16.2%
24/148 • 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
|
14.2%
22/155 • 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
|
10.2%
16/157 • 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
|
12.6%
19/151 • 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
|
14.2%
22/155 • 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
|
|
Nervous system disorders
Somnolence
|
3.4%
5/148 • 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
|
3.2%
5/155 • 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
|
2.5%
4/157 • 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
|
3.3%
5/151 • 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
|
7.1%
11/155 • 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
|
|
Psychiatric disorders
Insomnia
|
4.1%
6/148 • 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
|
5.2%
8/155 • 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
|
7.0%
11/157 • 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
|
2.0%
3/151 • 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
|
8.4%
13/155 • 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
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.68%
1/148 • 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
|
0.65%
1/155 • 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
|
2.5%
4/157 • 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
|
2.0%
3/151 • 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
|
6.5%
10/155 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The main publication has to be published before any sub-publications. H. Lundbeck A/S follows the Vancouver declaration with respect to authorship.
- Publication restrictions are in place
Restriction type: OTHER