Trial Outcomes & Findings for Investigating the Effect of Vortioxetine in Adult ADHD Patients (NCT NCT02327013)
NCT ID: NCT02327013
Last Updated: 2018-03-07
Results Overview
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
COMPLETED
PHASE2
227 participants
Baseline to Week 6
2018-03-07
Participant Flow
Participant milestones
| Measure |
Vortioxetine 10mg
Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2.
|
Vortioxetine 20mg
Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2.
|
Placebo - Placebo
Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group will consist of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
|
Placebo - Vortioxetine 10mg
Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.
|
Placebo - Vortioxetine 20mg
Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
45
|
96
|
21
|
16
|
|
Overall Study
COMPLETED
|
36
|
29
|
54
|
20
|
12
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
42
|
1
|
4
|
Reasons for withdrawal
| Measure |
Vortioxetine 10mg
Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2.
|
Vortioxetine 20mg
Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2.
|
Placebo - Placebo
Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group will consist of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
|
Placebo - Vortioxetine 10mg
Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.
|
Placebo - Vortioxetine 20mg
Patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
3
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
5
|
0
|
1
|
|
Overall Study
Non-compliance with IMP
|
1
|
2
|
7
|
0
|
0
|
|
Overall Study
Withdrawal of Consent
|
1
|
0
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
5
|
0
|
0
|
|
Overall Study
Administrative or other reason(s)
|
1
|
5
|
11
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
0
|
1
|
|
Overall Study
Withdrawal before treatment
|
2
|
1
|
5
|
0
|
0
|
Baseline Characteristics
Investigating the Effect of Vortioxetine in Adult ADHD Patients
Baseline characteristics by cohort
| Measure |
Placebo (Stage 1)
n=128 Participants
Patients treated wtih placebo in Stage 1.
|
Vortioxetine 10mg (Stage 1)
n=47 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg (Stage 1)
n=44 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Outcome measures
| Measure |
Placebo, Stage 1
n=109 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=41 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=34 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=20 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=20 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=12 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=129 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=61 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=46 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
|
-12.4 units on a scale
Standard Error 1.25
|
-12.8 units on a scale
Standard Error 1.99
|
-11.6 units on a scale
Standard Error 2.17
|
-4.1 units on a scale
Standard Error 1.92
|
-3.9 units on a scale
Standard Error 1.98
|
-2.9 units on a scale
Standard Error 2.35
|
-8.3 units on a scale
Standard Error 1.1
|
-8.3 units on a scale
Standard Error 1.4
|
-7.3 units on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The Metacognition Index (MI) is an index score of the BRIEF-A consisting of 5 scales: initiate, working memory, plan/organise, task monitor, and organization of materials. Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=107 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=41 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=34 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=20 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=20 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=12 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=127 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=61 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=46 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Using Metacognition Index
|
-10.0 T-score
Standard Error 1.26
|
-11.2 T-score
Standard Error 1.98
|
-10.2 T-score
Standard Error 2.16
|
-3.1 T-score
Standard Error 2.28
|
-2.6 T-score
Standard Error 2.34
|
0.9 T-score
Standard Error 2.84
|
-6.5 T-score
Standard Error 1.3
|
-6.9 T-score
Standard Error 1.5
|
-4.6 T-score
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
BRIEF-A is a validated questionnaire composed of 75-item within nine non-overlapping scales: 4 scales in the Behavioral Regulation Index (BRI) (inhibit, shift, emotional control, and self-monitor), and 5 scales in the Metacognition Index (MI) (initiate, working memory, plan/organise, task monitor, and organization of materials). Each item is rated on a 3-point scale with the numeric score of 1 to 3. The BRIEF-A yields an overall score (Global Executive Composite) composed of two index scores, the MI and the BRI. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=107 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=41 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=34 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=20 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=20 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=12 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=127 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=61 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=46 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score
|
-9.9 T-score
Standard Error 1.22
|
-12.5 T-score
Standard Error 1.93
|
-11.4 T-score
Standard Error 2.10
|
-3.0 T-score
Standard Error 2.24
|
-3.5 T-score
Standard Error 2.31
|
2.1 T-score
Standard Error 2.80
|
-6.5 T-score
Standard Error 1.3
|
-8.0 T-score
Standard Error 1.5
|
-4.6 T-score
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The SDS comprises a series of patient rated scales 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 scale, on which 0 = normal functioning and 10 = severe functional impairment. The number of days lost and the number of underproductive days last from work/school due to symptoms are also captured. The total score is calculated as a sum of the 3 visual analogue scales, ranges from 0 to 30. A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=92 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=34 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=28 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=18 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=17 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=11 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=110 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=51 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=39 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score
|
-5.3 units on a scale
Standard Error 0.74
|
-7.9 units on a scale
Standard Error 1.20
|
-7.4 units on a scale
Standard Error 1.29
|
0.6 units on a scale
Standard Error 0.91
|
-0.9 units on a scale
Standard Error 0.95
|
-1.4 units on a scale
Standard Error 1.14
|
-2.4 units on a scale
Standard Error 0.6
|
-4.4 units on a scale
Standard Error 0.8
|
-4.4 units on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24,9%.
Outcome measures
| Measure |
Placebo, Stage 1
n=91 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=36 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=27 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=15 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=17 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=11 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=106 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=53 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=38 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score
|
-2.4 percentage of days lost
Standard Error 0.54
|
-2.5 percentage of days lost
Standard Error 0.84
|
-2.4 percentage of days lost
Standard Error 0.96
|
-0.8 percentage of days lost
Standard Error 1.02
|
-0.9 percentage of days lost
Standard Error 0.97
|
-0.7 percentage of days lost
Standard Error 1.20
|
-1.6 percentage of days lost
Standard Error 0.6
|
-1.7 percentage of days lost
Standard Error 0.6
|
-1.5 percentage of days lost
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AISRS inattentive subscale score consists of 9 items from the AISRS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.
Outcome measures
| Measure |
Placebo, Stage 1
n=109 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=41 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=34 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=20 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=20 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=12 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=129 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=61 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=46 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in AISRS Inattention Sub-score
|
-6.5 units on a scale
Standard Error 0.71
|
-6.0 units on a scale
Standard Error 1.14
|
-5.9 units on a scale
Standard Error 1.24
|
-1.9 units on a scale
Standard Error 1.2
|
-2.0 units on a scale
Standard Error 1.21
|
-1.6 units on a scale
Standard Error 1.48
|
-4.2 units on a scale
Standard Error 0.7
|
-4.0 units on a scale
Standard Error 0.8
|
-3.8 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AISRS hyperactive/impulsive subscale score consists of 9 items from the AISRS which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.
Outcome measures
| Measure |
Placebo, Stage 1
n=109 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=41 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=34 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
n=20 Participants
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
n=20 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
n=12 Participants
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
n=129 Participants
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
n=61 Participants
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
n=46 Participants
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change AISRS Hyperactivity/Impulsivity Sub-score
|
-5.9 units on a scale
Standard Error 0.62
|
-7.0 units on a scale
Standard Error 0.99
|
-5.7 units on a scale
Standard Error 1.08
|
-2.1 units on a scale
Standard Error 0.93
|
-2.0 units on a scale
Standard Error 0.97
|
-1.2 units on a scale
Standard Error 1.15
|
-4.0 units on a scale
Standard Error 0.6
|
-4.5 units on a scale
Standard Error 0.7
|
-3.4 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined response rate was obtained by constructing an equally weighed estimate of the rate combining the two stages.
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Outcome measures
| Measure |
Placebo, Stage 1
n=145 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=66 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=56 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)
|
30.9 percentage of participants
|
27.5 percentage of participants
|
23.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The Adult ADHD Self-Report Scale (ASRS) is a patient-rated scale designed to assess the ADHD symptoms in adults based on the diagnostic criteria of DSM-IVTM. The ASRS consist of 18 items, each rated on a 5-point scale from "Never" to "Very Often". The categories "Never" and "Rarely" were combined when calculating the total score to mirror the scoring of the AISRS, with 0 representing "Never"/"Rarely" and 3 representing "Very Often". The Total Score ranges from 0 to 54. A reduction in score indicates less severity of ADHD.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult ADHD Self-Report Scale (ASRS) Total Score
|
-4.9 units on a scale
Standard Error 1.0
|
-6.5 units on a scale
Standard Error 1.3
|
-3.4 units on a scale
Standard Error 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo, Stage 1
n=129 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
|
-0.5 units on a scale
Standard Error 0.1
|
-0.7 units on a scale
Standard Error 0.1
|
-0.6 units on a scale
Standard Error 0.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: CGI-I refers to study baseline and was for this reason analyzed for Stage 1 only.
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo, Stage 1
n=124 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=40 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Global Impression - Global Improvement (CGI-I) Score
|
3.01 units on a scale
Standard Error 0.11
|
2.93 units on a scale
Standard Error 0.17
|
3.15 units on a scale
Standard Error 0.18
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6Population: CGI-I refers to study baseline and was for this reason analyzed for Stage 1 only.
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.
Outcome measures
| Measure |
Placebo, Stage 1
n=124 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=40 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Response (Defined as a CGI-I Score of 1 or 2), Stage 1
|
43 percentages of participants
|
13 percentages of participants
|
11 percentages of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The Behavioral Regulation Index (BRI) is an index score of the BRIEF-A and consists of 4 scales: inhibit, shift, emotional control, and self-monitor). Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Using the Behavioural Regulation Index
|
-5.3 T-score
Standard Error 1.1
|
-7.9 T-score
Standard Error 1.3
|
-3.9 T-score
Standard Error 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Inhibit is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=43 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Inhibit
|
-5.5 T-score
Standard Error 1.4
|
-8.6 T-score
Standard Error 1.5
|
-3.2 T-score
Standard Error 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Initiate is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change BRIEF-A Subscales - Initiate
|
-6.2 T-score
Standard Error 1.4
|
-5.8 T-score
Standard Error 1.6
|
-4.2 T-score
Standard Error 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Organization of Materials is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Organization of Materials
|
-4.4 T-score
Standard Error 1.1
|
-6.3 T-score
Standard Error 1.3
|
-3.2 T-score
Standard Error 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Planning/Organize is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Planning/Organize
|
-8.2 T-score
Standard Error 1.6
|
-8.7 T-score
Standard Error 1.8
|
-6.8 T-score
Standard Error 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Shift is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Shift
|
-5.6 T-score
Standard Error 1.4
|
-9.1 T-score
Standard Error 1.6
|
-3.5 T-score
Standard Error 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Self Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Self Monitor
|
-6.5 T-score
Standard Error 1.4
|
-11.0 T-score
Standard Error 1.6
|
-4.8 T-score
Standard Error 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Task Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Task Monitor
|
-6.4 T-score
Standard Error 1.5
|
-7.8 T-score
Standard Error 1.7
|
-4.9 T-score
Standard Error 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Working Memory is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Working Memory
|
-7.6 T-score
Standard Error 1.6
|
-9.9 T-score
Standard Error 1.8
|
-3.8 T-score
Standard Error 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The BRIEF-A subscale Emotional Control is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in BRIEF-A Subscales - Emotional Control
|
-3.4 T-score
Standard Error 1.0
|
-4.8 T-score
Standard Error 1.1
|
-3.5 T-score
Standard Error 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The PDQ-D is a patient-rated scale designed to assess cognitive impairment/dysfunction adapted for MDD. Each item is rated on a scale from 0 (never) to 4 (almost always). The total score of the 20 items ranges from 0 to 80 with higher scores reflect greater subjective cognitive impairment. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score
|
-7.6 units on a scale
Standard Error 1.6
|
-9.3 units on a scale
Standard Error 2.0
|
-6.3 units on a scale
Standard Error 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The PDQ-D attention/concentration sub-score consists of items 1, 5, 9, 13, and 17 of the PDQ with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in PDQ-D Subscales - Attention and Concentration Sub-score
|
-1.7 units on a scale
Standard Error 0.4
|
-2.3 units on a scale
Standard Error 0.5
|
-1.8 units on a scale
Standard Error 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The PDQ-D retrospective memory sub-score consists of items 2, 6, 10, 14, and 18 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in PDQ-D Sub-scales - Retrospective Memory Sub-score
|
-1.8 units on a scale
Standard Error 0.5
|
-2.4 units on a scale
Standard Error 0.6
|
-1.5 units on a scale
Standard Error 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The PDQ-D prospective memory sub-score consists of items 3, 7, 11, 15, and 19 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in PDQ-D Sub-scales - Prospective Memory Sub-score
|
-1.5 units on a scale
Standard Error 0.4
|
-2.3 units on a scale
Standard Error 0.5
|
-0.9 units on a scale
Standard Error 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The PDQ-D planning and organisation sub-score consists of items 4, 8, 12, 16, and 20 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in PDQ-D Sub-scales - Planning and Organisation Sub-score
|
-2.4 units on a scale
Standard Error 0.5
|
-2.5 units on a scale
Standard Error 0.6
|
-1.9 units on a scale
Standard Error 0.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The SDS item family is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in SDS Item Scores - Family
|
-1.5 units on a scale
Standard Error 0.3
|
-1.8 units on a scale
Standard Error 0.3
|
-1.5 units on a scale
Standard Error 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The SDS item work is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=109 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=50 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=38 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in SDS Item Scores - Work
|
-1.2 units on a scale
Standard Error 0.3
|
-2.0 units on a scale
Standard Error 0.4
|
-2.1 units on a scale
Standard Error 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The SDS item social life is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in SDS Item Scores - Social Life
|
-1.1 units on a scale
Standard Error 0.3
|
-1.7 units on a scale
Standard Error 0.3
|
-1.5 units on a scale
Standard Error 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
This SDS item captures days lost from school or work (see outcome 4).
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in SDS Item Scores - Number of Days Lost
|
-0.3 days
Standard Error 0.1
|
-0.2 days
Standard Error 0.1
|
-0.1 days
Standard Error 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
This SDS item captures the number of underproductive days (see outcome 4)
Outcome measures
| Measure |
Placebo, Stage 1
n=127 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=61 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=46 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in SDS Item Scores - Number of Underproductive Days
|
-1.2 days
Standard Error 0.3
|
-1.0 days
Standard Error 0.3
|
-1.2 days
Standard Error 0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The Global Productivity Index is calculated as a weighed sum of the 4 dimensions, and ranges from 0.000 to 0.286. Reduction in score indicates less work limitation.
Outcome measures
| Measure |
Placebo, Stage 1
n=106 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=37 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in WLQ Using the Global Productivity Index
|
-0.0 Index
Standard Error 0.0
|
-0.0 Index
Standard Error 0.0
|
-0.0 Index
Standard Error 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
Limitations Handling Time is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Outcome measures
| Measure |
Placebo, Stage 1
n=117 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=57 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=43 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in WLQ Domain Scores - Limitations Handling Time
|
-5.6 units on a scale
Standard Error 2.7
|
-7.7 units on a scale
Standard Error 3.1
|
-2.2 units on a scale
Standard Error 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
Mental-Interpersonal Work Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Outcome measures
| Measure |
Placebo, Stage 1
n=126 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=59 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=49 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in WLQ Domain Scores - Mental-Interpersonal Work Demands
|
-8.4 units on a scale
Standard Error 2.2
|
-8.2 units on a scale
Standard Error 2.6
|
-6.2 units on a scale
Standard Error 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
Physical Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Outcome measures
| Measure |
Placebo, Stage 1
n=115 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=43 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in WLQ Domain Scores - Physical Demands
|
-5.5 units on a scale
Standard Error 2.4
|
-5.0 units on a scale
Standard Error 2.9
|
-4.6 units on a scale
Standard Error 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
Output Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Outcome measures
| Measure |
Placebo, Stage 1
n=122 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=57 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=47 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in WLQ Domain Scores - Output Demands
|
-8.9 units on a scale
Standard Error 3.1
|
-7.1 units on a scale
Standard Error 3.5
|
-7.2 units on a scale
Standard Error 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Total score is based on all 29 items and ranges from 29 to 145. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score
|
7.7 units on a scale
Standard Error 1.7
|
9.1 units on a scale
Standard Error 2.1
|
5.4 units on a scale
Standard Error 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life productivity subscale is based on 11 items and ranges from 11 to 55. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in AAQoL Subscales - Life Productivity Sub-score
|
10.9 units on a scale
Standard Error 2.4
|
11.6 units on a scale
Standard Error 2.8
|
6.4 units on a scale
Standard Error 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Psychological Health subscale is based on 6 items and ranges from 6 to 30. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in AAQoL Subscales - Psychological Health Sub-score
|
6.7 units on a scale
Standard Error 2.2
|
10.3 units on a scale
Standard Error 2.5
|
5.7 units on a scale
Standard Error 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life Outlook subscale is based on 7 items and ranges from 7 to 35. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in AAQoL Subscales - Life Outlook Sub-score
|
3.7 units on a scale
Standard Error 1.3
|
5.0 units on a scale
Standard Error 1.7
|
3.0 units on a scale
Standard Error 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Relationship subscale is based on 5 items and ranges from 5 to 25. A reduction in score indicates less impairment.
Outcome measures
| Measure |
Placebo, Stage 1
n=132 Participants
Patients treated with placebo in Stage 1.
|
Vortioxetine 10mg, Stage 1
n=62 Participants
Patients treated with vortioxetine 10mg in Stage 1.
|
Vortioxetine 20mg, Stage 1
n=53 Participants
Patients treated with vortioxetine 20mg in Stage 1.
|
Placebo, Stage 2
Placebo responders from Stage 1 continue on placebo in Stage 2.
|
Vortioxetine 10mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 10mg in Stage 2.
|
Vortioxetine 20mg, Stage 2
Placebo non-responders from Stage 1 re-randomized to treatment with vortioxetine 20mg in Stage 2.
|
Placebo, Combined
Combined data from patients treated with placebo in Stage 1 and 2
|
Vortioxetine 10mg, Combined
Combined data from patients treated with vortioxetine 10mg in Stage 1 and 2
|
Vortioxetine 20mg, Combined
Combined data from patients treated with vortioxetine 20mg in Stage 1 and 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in AAQoL Subscales - Relationships Sub-score
|
7.4 units on a scale
Standard Error 2.1
|
8.1 units on a scale
Standard Error 2.5
|
6.0 units on a scale
Standard Error 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo-Placebo
Vortioxetine 10mg
Vortioxetine 20mg
Serious adverse events
| Measure |
Placebo-Placebo
n=91 participants at risk
Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group consists of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
|
Vortioxetine 10mg
n=68 participants at risk
Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.This group consists of patients who had received dosing of 10 mg vortioxetine in the study.
|
Vortioxetine 20mg
n=60 participants at risk
Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2. This group consists of patients who had received dosing of 20 mg vortioxetine in the study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
1.1%
1/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
1.5%
1/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
Other adverse events
| Measure |
Placebo-Placebo
n=91 participants at risk
Patients randomized to treatment with placebo in Stage 1 and continued on the same treatment in Stage 2. This group consists of placebo responders and placebo non-responders who were re-randomized to Placebo in Stage 2.
|
Vortioxetine 10mg
n=68 participants at risk
Patients randomized to treatment with vortioxetine 10mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 10mg/day in Stage 2.This group consists of patients who had received dosing of 10 mg vortioxetine in the study.
|
Vortioxetine 20mg
n=60 participants at risk
Patients randomized to treatment with vortioxetine 20mg/day in Stage 1 and continued on the same treatment in Stage 2. In addition, patients that did not respond to placebo in Stage 1 and were re-randomized to treatment with vortioxetine 20mg/day in Stage 2. This group consists of patients who had received dosing of 20 mg vortioxetine in the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
2/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
4/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
0.00%
0/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
3/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
4/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
8.3%
5/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Nausea
|
3.3%
3/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
22.1%
15/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
30.0%
18/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
4/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.0%
3/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
General disorders
Fatigue
|
11.0%
10/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
10.3%
7/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
18.3%
11/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
4/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
2.9%
2/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
6.7%
4/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Weight increased
|
2.2%
2/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
7.4%
5/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.0%
3/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dizziness
|
4.4%
4/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
4/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
3.3%
2/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Headache
|
18.7%
17/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
14.7%
10/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
16.7%
10/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Somnolence
|
3.3%
3/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
1.5%
1/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.0%
3/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Insomnia
|
9.9%
9/91 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
5.9%
4/68 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
8.3%
5/60 • Baseline to end of study (16 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place