Trial Outcomes & Findings for Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults (NCT NCT00839423)
NCT ID: NCT00839423
Last Updated: 2014-05-13
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
PHASE2
Target enrollment
426 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2014-05-13
Participant Flow
Outpatients with Major Depressive Episode (MDE) were recruited from psychiatric settings.
Eligible patients were randomised equally (1:1:1:1) to one of the 4 treatment arms for a 6-week double-blind treatment period. The doses of Vortioxetine were 5 mg/day or 10 mg/day for 6 weeks. The dose of venlafaxine was 75 mg/day for 4 days, 150 mg/day for the following 3 days, and 225 mg/day for the remainder of the treatment period.
Participant milestones
| Measure |
Placebo
capsules, daily, orally
|
Vortioxetine 5 mg
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
capsules, daily, orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
108
|
100
|
113
|
|
Overall Study
COMPLETED
|
87
|
98
|
82
|
93
|
|
Overall Study
NOT COMPLETED
|
18
|
10
|
18
|
20
|
Reasons for withdrawal
| Measure |
Placebo
capsules, daily, orally
|
Vortioxetine 5 mg
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
capsules, daily, orally
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
7
|
16
|
|
Overall Study
Lack of Efficacy
|
6
|
6
|
3
|
2
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal of consent
|
4
|
0
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Administrative or other reasons
|
3
|
0
|
1
|
0
|
Baseline Characteristics
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=113 Participants
capsules, daily, orally
|
Total
n=426 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
267 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
159 Participants
n=21 Participants
|
|
MADRS: Baseline Total Score
|
33.9 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
34.2 units on a scale
STANDARD_DEVIATION 3.1 • n=4 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 2.8 • n=21 Participants
|
|
Baseline 24-item HAM-D Total Score
|
29.7 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
29.9 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
29.3 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
29.4 units on a scale
STANDARD_DEVIATION 5.0 • n=4 Participants
|
29.6 units on a scale
STANDARD_DEVIATION 5.2 • n=21 Participants
|
|
HAM-A: Baseline Total Score
|
22.9 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
21.7 units on a scale
STANDARD_DEVIATION 6.2 • n=7 Participants
|
22.3 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
22.0 units on a scale
STANDARD_DEVIATION 5.5 • n=4 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 5.8 • n=21 Participants
|
|
CGI-S: Baseline Severity Score
|
5.1 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 0.7 • n=4 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 0.7 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF)
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=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=112 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
|
-14.50 units on a scale
Standard Error 1.03
|
-20.40 units on a scale
Standard Error 1.01
|
-20.20 units on a scale
Standard Error 1.04
|
-20.92 units on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: FAS, LOCF. Please note that 1 patient in each Vortioxetine group did not have a valid MADRS assessment at Week 1, but were included in the analysis because they had a valid MADRS assessment after Week 1.
Outcome measures
| Measure |
Placebo
n=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=107 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=99 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=112 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Change From Baseline in MADRS Total Score After 1 Week of Treatment
|
-5.04 units on a scale
Standard Error 0.50
|
-5.26 units on a scale
Standard Error 0.49
|
-5.86 units on a scale
Standard Error 0.51
|
-4.50 units on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS, LOCF
The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.
Outcome measures
| Measure |
Placebo
n=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=111 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
|
-12.23 units on a scale
Standard Error 0.90
|
-17.51 units on a scale
Standard Error 0.89
|
-17.57 units on a scale
Standard Error 0.92
|
-17.32 units on a scale
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS, LOCF
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=101 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=102 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=95 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=106 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment
|
-8.41 units on a scale
Standard Error 0.74
|
-11.71 units on a scale
Standard Error 0.75
|
-11.41 units on a scale
Standard Error 0.77
|
-11.29 units on a scale
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS, LOCF
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=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=111 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Change From Baseline in CGI-S Score After 6 Weeks of Treatment
|
-1.55 units on a scale
Standard Error 0.14
|
-2.45 units on a scale
Standard Error 0.14
|
-2.51 units on a scale
Standard Error 0.15
|
-2.58 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Week 6Population: FAS, LOCF
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=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=111 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Change in Clinical Status Using CGI-I Score at Week 6
|
2.64 units on a scale
Standard Error 0.12
|
2.05 units on a scale
Standard Error 0.12
|
2.04 units on a scale
Standard Error 0.12
|
1.96 units on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 6Population: FAS, LOCF
Outcome measures
| Measure |
Placebo
n=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=112 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
|
44.8 percentage of patients
|
66.7 percentage of patients
|
68.0 percentage of patients
|
72.3 percentage of patients
|
SECONDARY outcome
Timeframe: Week 6Population: FAS, LOCF
Outcome measures
| Measure |
Placebo
n=105 Participants
capsules, daily, orally
|
Vortioxetine 5 mg
n=108 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 10 mg
n=100 Participants
encapsulated tablets, daily, orally
|
Venlafaxine 225 mg
n=112 Participants
capsules, daily, orally
|
|---|---|---|---|---|
|
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
|
26.7 percentage of patients
|
49.1 percentage of patients
|
49.0 percentage of patients
|
55.4 percentage of patients
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Vortioxetine 5 mg
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Vortioxetine 10 mg
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Venlafaxine 225 mg
Serious events: 1 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=105 participants at risk
|
Vortioxetine 5 mg
n=108 participants at risk
|
Vortioxetine 10 mg
n=100 participants at risk
|
Venlafaxine 225 mg
n=113 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
Varicella
|
0.00%
0/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
1.0%
1/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.88%
1/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Psychiatric disorders
Depression
|
0.00%
0/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
1.0%
1/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
Other adverse events
| Measure |
Placebo
n=105 participants at risk
|
Vortioxetine 5 mg
n=108 participants at risk
|
Vortioxetine 10 mg
n=100 participants at risk
|
Venlafaxine 225 mg
n=113 participants at risk
|
|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
1.9%
2/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
1.9%
2/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
1.0%
1/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
5.3%
6/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Gastrointestinal disorders
Constipation
|
0.95%
1/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.93%
1/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
3.0%
3/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
9.7%
11/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
5/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
8.3%
9/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.0%
7/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
4.4%
5/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
7/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.4%
8/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
8.0%
8/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
16.8%
19/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Gastrointestinal disorders
Nausea
|
9.5%
10/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
29.6%
32/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
38.0%
38/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
33.6%
38/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
1/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
1.9%
2/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
9.0%
9/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
3.5%
4/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
General disorders
Fatigue
|
5.7%
6/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
3.7%
4/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
6.0%
6/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
9.7%
11/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
9/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.4%
8/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.0%
7/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
3.5%
4/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Nervous system disorders
Dizziness
|
7.6%
8/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
6.5%
7/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.0%
7/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
12.4%
14/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Nervous system disorders
Headache
|
24.8%
26/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
21.3%
23/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
25.0%
25/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
28.3%
32/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Nervous system disorders
Tremor
|
2.9%
3/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
4.6%
5/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
5.3%
6/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
6.2%
7/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Psychiatric disorders
Insomnia
|
4.8%
5/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
6.5%
7/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
6.0%
6/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
12.4%
14/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.00%
0/36 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/38 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/34 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.8%
4/51 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/36 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/38 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
0.00%
0/34 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
7.8%
4/51 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
2/105 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
2.8%
3/108 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
10.0%
10/100 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-week double-blind treatment period
|
15.0%
17/113 • Serious Adverse Events: 6-week double-blind treatment period and 4-week safety follow-up period Other Adverse Events: 6-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 publication. The investigators shall obtain Lundbeck's written approval before publishing any publication relating to Vortioxetine, the Study, the Protocol and/or the results recorded during the Study.
- Publication restrictions are in place
Restriction type: OTHER