Trial Outcomes & Findings for Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder (NCT NCT00707980)
NCT ID: NCT00707980
Last Updated: 2013-12-13
Results Overview
Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area. Each system was assessed as normal or abnormal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
836 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2013-12-13
Participant Flow
Participants took part in the study at 88 investigative sites in Australia, Croatia, France, Germany, Korea, Latvia, Lithuania, Malaysia, The Netherlands, Poland, Russia, Taiwan, Ukraine, and the United States from 17 June 2008 to 23 August 2010.
Participants who completed short-term efficacy and safety studies Lu AA21004\_304 (NCT00672620) and LuAA21004\_305 (NCT00735709) were eligible to receive the 52-week treatment with vortioxetine in this open-label extension study.
Participant milestones
| Measure |
Vortioxetine
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Overall Study
STARTED
|
836
|
|
Overall Study
Received Treatment
|
834
|
|
Overall Study
COMPLETED
|
526
|
|
Overall Study
NOT COMPLETED
|
310
|
Reasons for withdrawal
| Measure |
Vortioxetine
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Overall Study
Adverse Event
|
49
|
|
Overall Study
Lack of Efficacy
|
35
|
|
Overall Study
Non-Compliance with Study Drug
|
28
|
|
Overall Study
Protocol Deviations
|
19
|
|
Overall Study
Withdrawal of Consent
|
81
|
|
Overall Study
Lost to Follow-up
|
59
|
|
Overall Study
Other
|
39
|
Baseline Characteristics
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Vortioxetine
n=836 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Age Continuous
|
45.5 Years
STANDARD_DEVIATION 12.78 • n=5 Participants
|
|
Age, Customized
≤55 years
|
636 Participants
n=5 Participants
|
|
Age, Customized
>55 years
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
526 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
310 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian (White, including Hispanic)
|
693 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
86 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Non-Latino
|
782 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
207 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Republic of Korea
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
387 Participants
n=5 Participants
|
|
Weight
|
81.16 kg
STANDARD_DEVIATION 20.829 • n=5 Participants
|
|
Height
|
169.00 cm
STANDARD_DEVIATION 9.777 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.41 kg/m^2
STANDARD_DEVIATION 7.074 • n=5 Participants
|
|
24-item Hamilton Depression Scale total score
|
17.6 scores on a scale
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Montgomery Åsberg Depression Rating Scale (MADRS) total score
|
16.6 scores on a scale
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Hamilton Anxiety Scale total score
|
12.1 scores on a scale
STANDARD_DEVIATION 7.17 • n=5 Participants
|
|
Clinical Global Impression - Severity scale score
|
3.2 scores on a scale
STANDARD_DEVIATION 1.26 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.
Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area. Each system was assessed as normal or abnormal.
Outcome measures
| Measure |
Vortioxetine
n=834 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Physical Examination Findings
Extremities at Week 52: Normal
|
511 participants
|
|
Physical Examination Findings
Extremities at Week 52: Abnormal
|
13 participants
|
|
Physical Examination Findings
Skin at Baseline: Abnormal
|
104 participants
|
|
Physical Examination Findings
Skin at Week 52: Normal
|
465 participants
|
|
Physical Examination Findings
Skin at Week 52: Abnormal
|
59 participants
|
|
Physical Examination Findings
Head-Neck at Baseline: Normal
|
822 participants
|
|
Physical Examination Findings
Head-Neck at Baseline: Abnormal
|
12 participants
|
|
Physical Examination Findings
Head-Neck at Week 52: Abnormal
|
6 participants
|
|
Physical Examination Findings
Eyes-Ears-Nose-Throat at Baseline: Normal
|
772 participants
|
|
Physical Examination Findings
Eyes-Ears-Nose-Throat at Baseline: Abnormal
|
62 participants
|
|
Physical Examination Findings
Eyes-Ears-Nose-Throat at Week 52: Normal
|
485 participants
|
|
Physical Examination Findings
Eyes-Ears-Nose-Throat at Week 52: Abnormal
|
39 participants
|
|
Physical Examination Findings
Lungs-Chest at Baseline: Normal
|
827 participants
|
|
Physical Examination Findings
Lungs-Chest at Baseline: Abnormal
|
7 participants
|
|
Physical Examination Findings
Lungs-Chest at Week 52: Normal
|
523 participants
|
|
Physical Examination Findings
Lungs-Chest at Week 52: Abnormal
|
1 participants
|
|
Physical Examination Findings
Heart/Cardiovascular at Baseline: Normal
|
816 participants
|
|
Physical Examination Findings
Heart/Cardiovascular at Baseline: Abnormal
|
18 participants
|
|
Physical Examination Findings
Heart/Cardiovascular at Week 52: Normal
|
512 participants
|
|
Physical Examination Findings
Abdomen at Baseline: Abnormal
|
12 participants
|
|
Physical Examination Findings
Abdomen at Baseline: Not done
|
4 participants
|
|
Physical Examination Findings
Abdomen at Week 52: Normal
|
515 participants
|
|
Physical Examination Findings
Skin at Baseline: Normal
|
730 participants
|
|
Physical Examination Findings
Head-Neck at Week 52: Normal
|
518 participants
|
|
Physical Examination Findings
Heart/Cardiovascular at Week 52: Abnormal
|
12 participants
|
|
Physical Examination Findings
Abdomen at Baseline: Normal
|
818 participants
|
|
Physical Examination Findings
Abdomen at Week 52: Abnormal
|
8 participants
|
|
Physical Examination Findings
Abdomen at Week 52: Not done
|
1 participants
|
|
Physical Examination Findings
Musculoskeletal at Baseline: Normal
|
790 participants
|
|
Physical Examination Findings
Musculoskeletal at Baseline: Abnormal
|
44 participants
|
|
Physical Examination Findings
Musculoskeletal at Week 52: Normal
|
493 participants
|
|
Physical Examination Findings
Musculoskeletal at Week 52: Abnormal
|
31 participants
|
|
Physical Examination Findings
Appearance at Baseline: Normal
|
758 participants
|
|
Physical Examination Findings
Appearance at Baseline: Abnormal
|
76 participants
|
|
Physical Examination Findings
Appearance at Week 52: Normal
|
484 participants
|
|
Physical Examination Findings
Appearance at Week 52: Abnormal
|
40 participants
|
|
Physical Examination Findings
Extremities at Baseline: Normal
|
806 participants
|
|
Physical Examination Findings
Extremities at Baseline: Abnormal
|
28 participants
|
PRIMARY outcome
Timeframe: Weeks 4, 8, 12, 20, 28, 36, 44 and 52Population: Safety set
Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.
Outcome measures
| Measure |
Vortioxetine
n=834 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Bilirubin ≥ 34.2 μmol/L
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Glucose ≤ 2.8 mmol/L
|
9 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Glucose ≥ 13.9 mmol/L
|
7 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
High density lipoprotein cholesterol < 0.9 mmol/L
|
102 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Low density lipoprotein cholesterol ≥ 5.0 mmol/L
|
69 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Potassium ≤ 3.0 mmol/L
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Potassium ≥ 5.5 mmol/L
|
45 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Sodium ≤ 125 mmol/L
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Sodium ≥ 155 mmol/L
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Triglycerides ≥ 3.40 mmol/L
|
168 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Urate ≤ 0.7 X LLN
|
4 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Urate ≥ 1.3 XULN
|
12 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Eosinophils ≥ 0.6 10^9/L
|
24 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Erythrocytes ≤ 0.9 X LLN
|
9 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Erythrocytes ≥ 1.1 X ULN
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Hematocrit ≤ 0.9 X LLN
|
16 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Hemoglobin ≤ 0.9 X LLN
|
41 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Leukocytes ≤ 2.8 X 10^9/L
|
10 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Leukocytes ≥ 16 X 10^9/L
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Lymphocytes ≤ 0.6 X 10^9/L
|
5 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Lymphocytes ≥ 7 X 10^9/L
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Neutrophils ≤ 1.4 X 10^9/L
|
26 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Neutrophils ≥ 15 X 10^9/L
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Alanine aminotransferase (ALT) ≥ 3 X ULN
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Aspartate aminotransferase (AST) ≥ 3 X ULN
|
6 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Cholesterol ≥ 7.8 mmol/L
|
49 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Creatine kinase ≥ 2 X ULN
|
80 participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings
Creatinine ≥ 175 μmol/L
|
1 participants
|
PRIMARY outcome
Timeframe: Weeks 4, 12, 24, 36 and 52Population: Safety set
A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval \[QTc\]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.
Outcome measures
| Measure |
Vortioxetine
n=834 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Heart rate ≤50 bpm and change ≤-15bpm
|
9 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Heart rate ≥120 bpm and change ≥15 bpm
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
RR interval <500 msec and change ≤-200 msec
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
RR interval >1200 msec and change ≥200 msec
|
13 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR interval <120 msec
|
31 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR interval ≥250 msec
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QT interval <280 msec
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QT interval >500 msec
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcB <340 msec
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcB >500 msec
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcB Change <-60 msec
|
6 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcB Change >60 msec
|
4 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF <340 msec
|
0 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF >500 msec
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Change <-60 msec
|
3 participants
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Change >60 msec
|
2 participants
|
PRIMARY outcome
Timeframe: From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)Population: Safety set
The intensity (severity) of each AE was defined as: * Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities. * Moderate: sufficiently uncomfortable to produce some impairment of normal activities. * Severe: incapacitating, preventing the patient from participating in normal activities. The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion.
Outcome measures
| Measure |
Vortioxetine
n=834 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Moderate adverse event
|
320 participants
|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
589 participants
|
|
Number of Participants With Adverse Events (AEs)
Related adverse event
|
413 participants
|
|
Number of Participants With Adverse Events (AEs)
Not related adverse event
|
176 participants
|
|
Number of Participants With Adverse Events (AEs)
Mild adverse event
|
187 participants
|
|
Number of Participants With Adverse Events (AEs)
Severe adverse event
|
82 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse event leading to early termination
|
50 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event
|
29 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious related adverse event
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious not related adverse event
|
33 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event leading to early termination
|
11 participants
|
|
Number of Participants With Adverse Events (AEs)
Deaths
|
0 participants
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52Population: Safety set
Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.
Outcome measures
| Measure |
Vortioxetine
n=834 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
SSBP ≤90 mmHg and decrease of ≥20 mmHg
|
7 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
SSBP ≥180 mmHg and increase of ≥20 mmHg
|
4 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
SDBP ≤50 mmHg and decrease of ≥15 mmHg
|
1 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
SDBP ≥105 mmHg and increase of ≥15 mmHg
|
8 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Supine pulse rate ≤50 bpm and decrease of ≥15 bpm
|
7 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Supine pulse rate ≥120 bpm and increase of ≥15 bpm
|
2 participants
|
|
Number of Participants With Potentially Clinically Significant Vital Sign Findings
Weight Change of ≥7% weight
|
155 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.Population: Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. "n" indicates the number of patients included in the analysis at each time point.
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.
Outcome measures
| Measure |
Vortioxetine
n=829 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 1 (n=805)
|
-1.1 scores on a scale
Standard Deviation 5.27
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 2 (n=822)
|
-3.1 scores on a scale
Standard Deviation 6.10
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 4 (n=805)
|
-4.7 scores on a scale
Standard Deviation 7.07
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 8 (n=752)
|
-6.5 scores on a scale
Standard Deviation 7.43
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 12 (n=715)
|
-7.0 scores on a scale
Standard Deviation 8.27
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 16 (n=671)
|
-7.7 scores on a scale
Standard Deviation 8.45
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 20 (n=639)
|
-8.4 scores on a scale
Standard Deviation 8.51
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 24 (n=613)
|
-8.3 scores on a scale
Standard Deviation 8.92
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 28 (n=599)
|
-8.9 scores on a scale
Standard Deviation 8.91
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 36 (n=568)
|
-9.3 scores on a scale
Standard Deviation 9.05
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 44 (n=540)
|
-9.6 scores on a scale
Standard Deviation 9.32
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Week 52 (n=522)
|
-10.0 scores on a scale
Standard Deviation 8.86
|
|
Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score
Final Visit (n=829)
|
-7.9 scores on a scale
Standard Deviation 9.66
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 24 and 52Population: Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. "n" indicates the number of patients included in the analysis at each time point.
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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.
Outcome measures
| Measure |
Vortioxetine
n=818 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Week 4 (n=818)
|
-4.5 scores on a scale
Standard Deviation 7.38
|
|
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Week 24 (n=642)
|
-7.9 scores on a scale
Standard Deviation 9.24
|
|
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Week 52 (n=526)
|
-9.5 scores on a scale
Standard Deviation 8.90
|
|
Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score
Final Visit (n=818)
|
-7.4 scores on a scale
Standard Deviation 9.81
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 24 and 52Population: Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. "n" indicates the number of patients included in the analysis at each time point.
The 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 to 56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.
Outcome measures
| Measure |
Vortioxetine
n=818 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Week 4 (n=818)
|
-2.9 scores on a scale
Standard Deviation 5.12
|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Week 24 (n=642)
|
-5.1 scores on a scale
Standard Deviation 6.44
|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Week 52 (n=527)
|
-6.6 scores on a scale
Standard Deviation 6.38
|
|
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score
Final Visit (n= 818)
|
-5.2 scores on a scale
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 24 and 52Population: Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. "n" indicates the number of patients included in the analysis at each time point.
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate 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. Considering total clinical experience, a patient is assessed on severity of mental illness 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. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.
Outcome measures
| Measure |
Vortioxetine
n=818 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Change From Baseline in the Clinical Global Impression of Severity of Illness Scale
Week 4 (n=818)
|
-0.53 scores on a scale
Standard Deviation 1.002
|
|
Change From Baseline in the Clinical Global Impression of Severity of Illness Scale
Week 24 (n=642)
|
-0.98 scores on a scale
Standard Deviation 1.295
|
|
Change From Baseline in the Clinical Global Impression of Severity of Illness Scale
Week 52 (n= 527)
|
-1.33 scores on a scale
Standard Deviation 1.266
|
|
Change From Baseline in the Clinical Global Impression of Severity of Illness Scale
Final Visit (n=818)
|
-1.00 scores on a scale
Standard Deviation 1.338
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.
The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).
Outcome measures
| Measure |
Vortioxetine
n=824 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
General health subscore (n=823)
|
6.4 scores on a scale
Standard Deviation 18.38
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Social functioning subscore (n=824)
|
10.9 scores on a scale
Standard Deviation 26.90
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Physical functioning subscore (n=824)
|
4.5 scores on a scale
Standard Deviation 15.88
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Role-physical subscore (n=824)
|
8.1 scores on a scale
Standard Deviation 25.51
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Bodily pain subscore (n=824)
|
4.9 scores on a scale
Standard Deviation 24.29
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Vitality subscore (n=824)
|
10.1 scores on a scale
Standard Deviation 23.03
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Role-emotional subscore (n=824)
|
12.3 scores on a scale
Standard Deviation 28.24
|
|
Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)
Mental health subscore (n=824)
|
10.7 scores on a scale
Standard Deviation 22.04
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.
The Sheehan Disability Scale (SDS) 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.
Outcome measures
| Measure |
Vortioxetine
n=536 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Change From Baseline to the Final Visit in the Sheehan Disability Scale
|
-4.6 scores on a scale
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Safety set with available data
Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.
Outcome measures
| Measure |
Vortioxetine
n=834 Participants
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Sick leave related to depression
|
42 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 52: Any resource use
|
138 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Any resource use
|
137 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Any hospitalization-related services
|
4 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Hospitalization related to depression
|
0 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Baseline: Any sick leave
|
53 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 52:Any hospitalization-related services
|
7 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Final Visit: Hospitalization related to depression
|
0 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 52: Any sick leave
|
41 participants
|
|
Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire
Week 52: Sick leave related to depression
|
25 participants
|
Adverse Events
Vortioxetine
Serious events: 29 serious events
Other events: 452 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vortioxetine
n=834 participants at risk
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Edema peripheral
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess limb
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.24%
2/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ischemic stroke
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Major depression
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.24%
2/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Surgical and medical procedures
Abortion induced
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.12%
1/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Vortioxetine
n=834 participants at risk
Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
15.2%
127/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
60/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
30/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
28/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
25/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
25/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
3.6%
30/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
82/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
53/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
4.0%
33/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
23/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
2.3%
19/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight increased
|
4.3%
36/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
32/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
12.2%
102/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
6.8%
57/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
4.0%
33/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
2.0%
17/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
17/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
2.3%
19/834 • From first dose of study until 30 days after the last dose.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER