Clinical Trial Results:
An interventional, randomised, double-blind, parallel-group, active-comparator, flexible-dose study on the efficacy of vortioxetine versus escitalopram on cognitive dysfunction in patients with inadequate response to current antidepressant treatment of major depressive disorder
Summary
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EudraCT number |
2014-000231-16 |
Trial protocol |
DE FI SK |
Global end of trial date |
01 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Feb 2017
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First version publication date |
19 Feb 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
15907A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02272517 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
H. Lundbeck A/S
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Sponsor organisation address |
Ottiliavej 9, Valby, Denmark, 2500
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Public contact |
Lundbeck Clinical Trials, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
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Scientific contact |
Lundbeck Clinical Trials, H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Mar 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment.
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Dec 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Slovakia: 19
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Country: Number of subjects enrolled |
Finland: 37
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Country: Number of subjects enrolled |
Germany: 10
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Country: Number of subjects enrolled |
Serbia: 35
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Worldwide total number of subjects |
101
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EEA total number of subjects |
66
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
100
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
In- or outpatients with a primary diagnosis of MDD according to DSM-IV-TR™ criteria, as confirmed using the Mini International Neuropsychiatric Interview (MINI), who had a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening Visit. Patients had to be candidates for a switch due to inadequate response to antidepressant | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Period 1 (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Vortioxetine 10-20mg | |||||||||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
vortioxetine 10 mg/day
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Investigational medicinal product code |
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Other name |
Brintellix, Trintellix
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg/day; encapsulated tablets, orally, 8 weeks
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
powder-filled capsules, orally, 1 week
After 8-week, double-blind treatment period, patients entered a 1-week, double-blind, taper-down period: patients treated with vortioxetine received placebo
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Investigational medicinal product name |
vortioxetine 20 mg/day
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Investigational medicinal product code |
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Other name |
Brintellix, Trintellix
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
20 mg/day; encapsulated tablets, orally, 8 weeks
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Arm title
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Escitalopram 10-20mg | |||||||||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Escitalopram 20 mg/day
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
20mg/day; encapsulated tablets, orally, 8 weeks;
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Investigational medicinal product name |
Escitalopram 10 mg/day
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg/day; encapsulated tablets, orally, 8 weeks
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
powder-filled capsules, orally, 1 week
After 8-week, double-blind treatment period, patients entered a 1-week, double-blind, taper-down period: patients treated with 10mg/day escitalopram received placebo
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Baseline characteristics reporting groups
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Reporting group title |
Vortioxetine 10-20mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Escitalopram 10-20mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Vortioxetine 10-20mg
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Reporting group description |
- | ||
Reporting group title |
Escitalopram 10-20mg
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Reporting group description |
- |
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End point title |
Change from baseline to Week 8 in Digit Symbol Substitution Test (DSST) | ||||||||||||
End point description |
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)
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End point type |
Primary
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End point timeframe |
baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.228 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.28 | ||||||||||||
upper limit |
5.28 |
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End point title |
Change from baseline to Week 8 in University of San Diego Performance-based Skills Assessment – Brief (UPSA-B) total score | ||||||||||||
End point description |
The UPSA-B is a role-play based performance test designed to assess functional skills in patients with mental illness. The UPSA-B consists of two subscales: managing finances (for example, counting correct change, writing a check to pay a bill) and communication with others (for example, dialing an emergency telephone number, rescheduling a medical appointment). Raw scores of the two subscales are converted to scaled scores from 0 to 100, where higher scores indicate better functional capacity.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
97
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.3457 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
1.34
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.47 | ||||||||||||
upper limit |
4.15 |
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End point title |
Change from baseline to Week 8 in Rey Auditory Visual Learning Test (RAVLT) score: Acquisition | ||||||||||||
End point description |
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 encoding versus retrieval. The RAVLT consists of a number of tasks where the RAVLT acquisition (learning) is the total number of correctly recalled words from three lists of words with a possible score between 0 and 45. The higher score the better performance
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.5 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.66
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.27 | ||||||||||||
upper limit |
2.59 |
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End point title |
Change from baseline to Week 8 in Rey Auditory Visual Learning Test (RAVLT) score. Delayed recall | ||||||||||||
End point description |
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 encoding versus retrieval. The RAVLT consists of a number of tasks where RAVLT delayed recall (memory) is the number of correctly recalled words at the end of the test battery from one list of words with a possible score between 0 and 15. The higher score the better performance
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.3347 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.42
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.44 | ||||||||||||
upper limit |
1.29 |
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End point title |
Change from baseline to Week 8 in Trail Making Test A (TMT-A) score | ||||||||||||
End point description |
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. Part A assesses cognitive processing speed. The lower the score the faster the processing speed
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End point type |
Secondary
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End point timeframe |
baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.4684 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
1.81
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-3.12 | ||||||||||||
upper limit |
6.73 |
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End point title |
Change from baseline to Week 8 in Trail Making Test B (TMT-B) score | ||||||||||||
End point description |
TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.6896 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-2.54
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-15.16 | ||||||||||||
upper limit |
10.08 |
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End point title |
Change from baseline to Week 8 in Simple Reaction Time (SRT) | ||||||||||||
End point description |
Simple Reaction Time (SRT) is designed to assess psychomotor speed. The patient presses a "yes" button, whenever an onscreen playing card is turned over. The lower score the better performance
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.7726 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.007
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.041 | ||||||||||||
upper limit |
0.055 |
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End point title |
Change from baseline to Week 8 in Choice Reaction Time (CRT) | ||||||||||||
End point description |
Choice Reaction Time (CRT) is designed to assess visual attention. 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. The lower score the better performance
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.3118 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.019
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.055 | ||||||||||||
upper limit |
0.018 |
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End point title |
Change from baseline to Week 8 in Stroop Colour Naming Test (STROOP) score: Congruent | ||||||||||||
End point description |
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. The STROOP comprises two sheets with 50 words on each, and each word is the name of a colour.
In the Congruent STROOP Sheet, the word and ink colour match. The lower the score the faster the processing speed
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0827 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-3.4
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-7.25 | ||||||||||||
upper limit |
0.45 |
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End point title |
Change from baseline to Week 8 in Stroop Colour Naming Test (STROOP) score: Incongruent | ||||||||||||
End point description |
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. The STROOP comprises two sheets with 50 words on each, and each word is the name of a colour. In the Incongruent STROOP Sheet, the word and ink colour do not match. The lower the score the greater the cognitive flexibility
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End point type |
Secondary
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End point timeframe |
Baseline to Week 8
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Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
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||||||||||||
Number of subjects included in analysis |
93
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.1035 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-6.42
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-14.17 | ||||||||||||
upper limit |
1.34 |
|
|||||||||||||
End point title |
Change from baseline to Week 8 in Perceived Deficits Questionnaire – Depression (PDQ-D) total score | ||||||||||||
End point description |
Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization. The total score of the 20 items ranges from 0 to 80 with higher scores reflecting greater subjective cognitive dysfunction as perceived by the patient
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline to Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Escitalopram 10-20mg v Vortioxetine 10-20mg
|
||||||||||||
Number of subjects included in analysis |
93
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.1163 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-4.14
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-9.32 | ||||||||||||
upper limit |
1.05 |
|
|||||||||||||
End point title |
Change from baseline to Week 8 in Patient Health Questionnaire-9 (PHQ-9) total score | ||||||||||||
End point description |
The PHQ-9 is a patient-rated scale designed to screen for and to assess severity of depression. The PHQ-9 consists of questions on each of the 9 DSM-IV criteria for depression asking if they have bothered the patient over the last 2 weeks. The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline to Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
|
||||||||||||
Number of subjects included in analysis |
92
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.2372 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-1.25
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-3.34 | ||||||||||||
upper limit |
0.84 |
|
|||||||||||||
End point title |
Change from baseline to Week 8 in Clinical Global Impression – Severity of Illness (CGI-S) score | ||||||||||||
End point description |
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).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline to Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
|
||||||||||||
Number of subjects included in analysis |
92
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.1247 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.32
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.73 | ||||||||||||
upper limit |
0.09 |
|
|||||||||||||
End point title |
Clinical Global Impression – Global Improvement (CGI-I) score at Week 8 | ||||||||||||
End point description |
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
|
||||||||||||
Number of subjects included in analysis |
92
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.4659 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.13
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.49 | ||||||||||||
upper limit |
0.23 |
|
|||||||||||||
End point title |
Change from baseline to Week 8 in Functioning Assessment Short Test (FAST) total score | ||||||||||||
End point description |
The FAST is a clinician-rating scale designed to assess difficulty in functioning. The FAST assesses 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, leisure time. The total score of the 24 items ranges from 0 to 72 with higher scores reflecting more serious difficulties
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline to Week 8
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Comparison to Escitalopram | ||||||||||||
Comparison groups |
Vortioxetine 10-20mg v Escitalopram 10-20mg
|
||||||||||||
Number of subjects included in analysis |
93
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.8023 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.64
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-5.74 | ||||||||||||
upper limit |
4.45 |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
First dose to follow-up
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Escitalopram 10-20 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Escitalopram 10-20 MG | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vortioxetine 10-20 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Vortioxetine 10-20 MG | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |