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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000231-16 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram 10-20 mg | Active Comparator | Encapsulated tablets once daily for 8 weeks |
|
| Vortioxetine 10-20 mg | Experimental | Encapsulated tablets once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10-20 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Digit Symbol Substitution Test (DSST) | The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rey Auditory Verbal Learning Test (RAVLT) | Learning [acquisition] and memory [delayed recall]) | Baseline to Week 8 |
| Change in Trail Making Test A (TMT-A) | Speed of processing |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H.Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FI005 | Helsinki | Finland | ||||
| FI001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30439678 | Derived | Christensen MC, Sluth LB, McIntyre RS. Validation of the University of California San Diego Performance-based Skills Assessment (UPSA) in major depressive disorder: Replication and extension of initial findings. J Affect Disord. 2019 Feb 15;245:508-516. doi: 10.1016/j.jad.2018.11.034. Epub 2018 Nov 5. |
| Label | URL |
|---|---|
| EMA EudraCT Results: 2014-000230-34 | View source |
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| Escitalopram 10-20 mg |
| Drug |
|
| Baseline to Week 8 |
| Change in Trail Making Test B (TMT-B) | Executive functioning | Baseline to Week 8 |
| Change in Reaction time score; CRT attention | Baseline to Week 8 |
| Change in reaction time score SRT - simple reaction time | Baseline to week 8 |
| Change in STROOP incongruent score | Executive functioning | Baseline to Week 8 |
| Change in STROOP congruent score | Speed of processing | Baseline to Week 8 |
| Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score | Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization | Baseline to Week 8 |
| Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score | Patient-reported outcome | Baseline to Week 8 |
| Change in Clinical Global Improvement - Severity (CGI-S) | Baseline to Week 8 |
| Clinical Global Improvement (CGI-I) | Week 8 |
| Change in Functioning Assessment Short Test (FAST) | Baseline to Week 8 |
| Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score | Baseline to Week 8 |
| Kuopio |
| Finland |
| FI006 | Kupio | Finland |
| FI007 | Tampere | Finland |
| FI004 | Turku | Finland |
| DE005 | Bochum | Germany |
| DE004 | Mittweida | Germany |
| RS002 | Belgrade | Serbia |
| RS003 | Belgrade | Serbia |
| RS004 | Belgrade | Serbia |
| RS005 | Belgrade | Serbia |
| RS001 | Kragujevac | Serbia |
| SK004 | Bratislava | Slovakia |
| SK001 | Domaša | Slovakia |
| SK003 | Levice | Slovakia |
| SK002 | Rimavská Sobota | Slovakia |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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