Trial Outcomes & Findings for Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (NCT NCT01422213)
NCT ID: NCT01422213
Last Updated: 2014-08-05
Results Overview
DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (\< normal functioning) to 133 (\> normal functioning). RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded. The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25.
COMPLETED
PHASE3
598 participants
Baseline and Week 8
2014-08-05
Participant Flow
Patients were selected from psychiatric settings, outpatient clinics, and inpatient hospitals; and recruited via ads (if allowed in the country) or referrals (from general practitioners). A Pre-Randomisation Form completed by the site for each patient was reviewed by the CRO Medical Expert to confirm patient eligibility prior to randomisation.
Patients were randomised equally (1:1:1) at the Baseline Visit to placebo, vortioxetine 10 mg/day, or vortioxetine 20 mg/day for 8 weeks of double-blind treatment (8-week Core Treatment Period).
Participant milestones
| Measure |
Placebo
capsules; daily; orally
|
Vortioxetine 10 mg
encapsulated tablets; daily; orally
|
Vortioxetine 20 mg
encapsulated tablets; daily; orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
196
|
195
|
207
|
|
Overall Study
COMPLETED
|
163
|
173
|
178
|
|
Overall Study
NOT COMPLETED
|
33
|
22
|
29
|
Reasons for withdrawal
| Measure |
Placebo
capsules; daily; orally
|
Vortioxetine 10 mg
encapsulated tablets; daily; orally
|
Vortioxetine 20 mg
encapsulated tablets; daily; orally
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
11
|
|
Overall Study
Lack of Efficacy
|
10
|
2
|
2
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
4
|
|
Overall Study
Withdrawal of Consent
|
7
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
5
|
|
Overall Study
Administrative or Other Reason(s)
|
5
|
4
|
2
|
Baseline Characteristics
Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=196 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=195 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=207 Participants
encapsulated tablets, daily, orally
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
DSST: Baseline Total Score
|
42.38 units on a scale
STANDARD_DEVIATION 13.76 • n=5 Participants
|
41.96 units on a scale
STANDARD_DEVIATION 12.56 • n=7 Participants
|
41.61 units on a scale
STANDARD_DEVIATION 12.72 • n=5 Participants
|
41.98 units on a scale
STANDARD_DEVIATION 13.00 • n=4 Participants
|
|
RAVLT: Baseline Total Score
|
22.14 correct words
STANDARD_DEVIATION 5.70 • n=5 Participants
|
22.34 correct words
STANDARD_DEVIATION 5.76 • n=7 Participants
|
22.64 correct words
STANDARD_DEVIATION 5.88 • n=5 Participants
|
22.38 correct words
STANDARD_DEVIATION 5.77 • n=4 Participants
|
|
TMT A: Baseline Total Score
|
48.71 seconds
STANDARD_DEVIATION 24.73 • n=5 Participants
|
46.51 seconds
STANDARD_DEVIATION 24.12 • n=7 Participants
|
46.23 seconds
STANDARD_DEVIATION 26.66 • n=5 Participants
|
47.13 seconds
STANDARD_DEVIATION 25.20 • n=4 Participants
|
|
TMT B: Baseline Total Score
|
105.05 seconds
STANDARD_DEVIATION 52.99 • n=5 Participants
|
101.82 seconds
STANDARD_DEVIATION 51.68 • n=7 Participants
|
102.94 seconds
STANDARD_DEVIATION 52.43 • n=5 Participants
|
103.27 seconds
STANDARD_DEVIATION 52.30 • n=4 Participants
|
|
STROOP Congruent: Baseline Total Score
|
49.97 seconds
STANDARD_DEVIATION 24.86 • n=5 Participants
|
49.59 seconds
STANDARD_DEVIATION 24.65 • n=7 Participants
|
50.01 seconds
STANDARD_DEVIATION 27.58 • n=5 Participants
|
49.86 seconds
STANDARD_DEVIATION 25.72 • n=4 Participants
|
|
STROOP Incongruent: Baseline Total Score
|
85.66 seconds
STANDARD_DEVIATION 39.15 • n=5 Participants
|
85.03 seconds
STANDARD_DEVIATION 41.09 • n=7 Participants
|
83.62 seconds
STANDARD_DEVIATION 41.40 • n=5 Participants
|
84.75 seconds
STANDARD_DEVIATION 40.51 • n=4 Participants
|
|
SRT: Baseline Total Score
|
2.64 log10 (ms)
STANDARD_DEVIATION 0.20 • n=5 Participants
|
2.64 log10 (ms)
STANDARD_DEVIATION 0.20 • n=7 Participants
|
2.63 log10 (ms)
STANDARD_DEVIATION 0.20 • n=5 Participants
|
2.64 log10 (ms)
STANDARD_DEVIATION 0.20 • n=4 Participants
|
|
CRT: Baseline Total Score
|
2.78 log10 (ms)
STANDARD_DEVIATION 0.14 • n=5 Participants
|
2.78 log10 (ms)
STANDARD_DEVIATION 0.14 • n=7 Participants
|
2.78 log10 (ms)
STANDARD_DEVIATION 0.14 • n=5 Participants
|
2.78 log10 (ms)
STANDARD_DEVIATION 0.14 • n=4 Participants
|
|
MADRS: Baseline Total Score
|
31.34 units on a scale
STANDARD_DEVIATION 3.75 • n=5 Participants
|
31.62 units on a scale
STANDARD_DEVIATION 3.77 • n=7 Participants
|
31.74 units on a scale
STANDARD_DEVIATION 3.53 • n=5 Participants
|
31.57 units on a scale
STANDARD_DEVIATION 3.68 • n=4 Participants
|
|
CGI-S: Baseline Total Score
|
4.55 units on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
4.60 units on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
4.62 units on a scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
4.59 units on a scale
STANDARD_DEVIATION 0.61 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: FAS
DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (\< normal functioning) to 133 (\> normal functioning). RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded. The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25.
Outcome measures
| Measure |
Placebo
n=178 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=187 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores
|
-0.235 z score
Standard Error 0.053
|
0.128 z score
Standard Error 0.052
|
0.095 z score
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.
Outcome measures
| Measure |
Placebo
n=179 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=187 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in DSST (Number of Correct Symbols)
|
4.83 number of correct symbols
Standard Error 0.63
|
9.03 number of correct symbols
Standard Error 0.63
|
9.09 number of correct symbols
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.
Outcome measures
| Measure |
Placebo
n=179 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=187 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in RAVLT (Acquisition)
|
3.06 number of words correctly recalled
Standard Error 0.34
|
4.08 number of words correctly recalled
Standard Error 0.34
|
3.65 number of words correctly recalled
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.
Outcome measures
| Measure |
Placebo
n=178 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=187 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in RAVLT (Delayed Recall)
|
0.91 number of words correctly recalled
Standard Error 0.18
|
1.63 number of words correctly recalled
Standard Error 0.18
|
1.56 number of words correctly recalled
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.
Outcome measures
| Measure |
Placebo
n=179 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=187 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the TMT A (Speed of Processing)
|
-7.07 seconds
Standard Error 1.00
|
-10.84 seconds
Standard Error 1.00
|
-10.87 seconds
Standard Error 0.97
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.
Outcome measures
| Measure |
Placebo
n=179 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=186 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the TMT B (Executive Function)
|
-13.84 seconds
Standard Error 2.00
|
-21.41 seconds
Standard Error 2.00
|
-22.85 seconds
Standard Error 1.95
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.
Outcome measures
| Measure |
Placebo
n=179 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=180 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=186 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)
|
-5.97 seconds
Standard Error 0.93
|
-9.97 seconds
Standard Error 0.93
|
-10.43 seconds
Standard Error 0.90
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Outcome measures
| Measure |
Placebo
n=176 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=178 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=184 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)
|
-10.94 seconds
Standard Error 1.48
|
-17.69 seconds
Standard Error 1.48
|
-17.45 seconds
Standard Error 1.44
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds: * The "detection task" measures SRT: the patient presses a "yes" button, whenever an onscreen playing card is turned over. * The "identification task" measures CRT: the patient presses a "yes" button whenever an onscreen playing card is turned over and is red, or a "no" button if the card is not red.
Outcome measures
| Measure |
Placebo
n=169 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=176 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=176 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the SRT (Speed of Processing)
|
-0.007 log10 (ms)
Standard Error 0.009
|
-0.053 log10 (ms)
Standard Error 0.009
|
-0.037 log10 (ms)
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
Outcome measures
| Measure |
Placebo
n=169 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=176 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=180 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the CRT (Attention)
|
-0.015 log10 (ms)
Standard Error 0.007
|
-0.046 log10 (ms)
Standard Error 0.007
|
-0.023 log10 (ms)
Standard Error 0.006
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
Outcome measures
| Measure |
Placebo
n=165 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=174 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=181 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in MADRS Total Score
|
-10.85 units on a scale
Standard Error 0.64
|
-15.56 units on a scale
Standard Error 0.63
|
-17.55 units on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
Outcome measures
| Measure |
Placebo
n=165 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=174 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=181 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 in CGI-S Score
|
-1.15 units on a scale
Standard Error 0.08
|
-1.80 units on a scale
Standard Error 0.08
|
-2.00 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Week 8Population: FAS
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
Outcome measures
| Measure |
Placebo
n=165 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=174 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=181 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Clinical Status Using CGI-I Score at Week 8
|
2.85 units on a scale
Standard Error 0.08
|
2.24 units on a scale
Standard Error 0.08
|
1.99 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS, last observation carried forward (LOCF)
Outcome measures
| Measure |
Placebo
n=194 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=193 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=204 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline
|
29.4 percentage of participants
|
47.7 percentage of participants
|
58.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS, LOCF
Outcome measures
| Measure |
Placebo
n=194 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=193 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=204 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)
|
17.0 percentage of participants
|
29.5 percentage of participants
|
38.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 1Population: FAS, LOCF
Effect on cognitive dysfunction after correcting for the effect on depressive symptoms. The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables. In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study.
Outcome measures
| Measure |
Placebo
n=193 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=389 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score
|
-0.079 z score
Standard Error 0.050
|
0.042 z score
Standard Error 0.037
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: FAS, LOCF
Effect on cognitive dysfunction after correcting for the effect on depressive symptoms. The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.
Outcome measures
| Measure |
Placebo
n=194 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=193 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=204 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score
|
-0.189 z score
Standard Error 0.050
|
0.041 z score
Standard Error 0.049
|
-0.036 z score
Standard Error 0.048
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: APTS
The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study.
Outcome measures
| Measure |
Placebo
n=196 Participants
capsules, daily, orally
|
Vortioxetine 10 mg
n=195 Participants
encapsulated tablets, daily, orally
|
Vortioxetine 20 mg
n=207 Participants
encapsulated tablets, daily, orally
|
|---|---|---|---|
|
Risk of Suicidality Using C-SSRS Scores
No suicidal ideation or behaviour
|
173 participants
|
175 participants
|
178 participants
|
|
Risk of Suicidality Using C-SSRS Scores
Any non-suicidal self-injurious behavior
|
0 participants
|
0 participants
|
0 participants
|
|
Risk of Suicidality Using C-SSRS Scores
Any suicidal ideation or behaviour
|
21 participants
|
18 participants
|
27 participants
|
Adverse Events
Placebo
Vortioxetine 10 mg
Vortioxetine 20 mg
Serious adverse events
| Measure |
Placebo
n=196 participants at risk
|
Vortioxetine 10 mg
n=195 participants at risk
|
Vortioxetine 20 mg
n=207 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Hiatus hernia
|
0.51%
1/196
|
0.00%
0/195
|
0.00%
0/207
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/196
|
0.00%
0/195
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/196
|
0.00%
0/195
|
0.48%
1/207
|
|
Vascular disorders
Hypertension
|
0.00%
0/196
|
0.00%
0/195
|
0.48%
1/207
|
Other adverse events
| Measure |
Placebo
n=196 participants at risk
|
Vortioxetine 10 mg
n=195 participants at risk
|
Vortioxetine 20 mg
n=207 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.1%
8/196
|
16.4%
32/195
|
20.8%
43/207
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
10/196
|
3.6%
7/195
|
4.3%
9/207
|
|
Nervous system disorders
Headache
|
7.1%
14/196
|
8.2%
16/195
|
12.6%
26/207
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study will be published. Authors of the primary publication based on this study must fulfil the criteria defined by the International Committee of Medical Journal Editors (ICMJE). The primary publication must be published before any secondary publications are submitted for publication.
- Publication restrictions are in place
Restriction type: OTHER