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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000229-19 | EudraCT Number |
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To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning and attention) in patients who are in partial or full remission from their Major Depressive Episode (MDE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 10-20 mg | Experimental | daily, encapsulated, orally |
|
| Vortioxetine 10-20 mg + SSRI | Experimental | daily, encapsulated, orally |
|
| SSRI | Experimental | licensed doses, encapsulated, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10-20 mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Digit Symbol Substitution Test (DSST): number of correct symbols | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition]) | Baseline to Week 8 | |
| Change in Trail Making Test (TMT) score: TMT-A; speed of processing | Baseline to Week 8 |
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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 |
|---|---|---|---|---|---|---|
| EE001 | Tallinn | Estonia | ||||
| EE002 |
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| Label | URL |
|---|---|
| Results EudraCT 2014-000229-19 | View source |
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| Placebo | Drug |
|
| SSRI | Drug | escitalopram, citalopram or sertraline |
|
| Change in TMT score: TMT-B; executive functioning | Baseline to Week 8 |
| Change in reaction time score: Choice Reaction Time (CRT); attention | Baseline to Week 8 |
| Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed | Baseline to Week 8 |
| Change in Stroop Colour Naming Test (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 | Baseline to Week 8 |
| Change in Hamilton Depression Rating Scale-17 (HAMD-17) total score | Baseline to Week 8 |
| Change in Clinical Global Impression - Severity of Illness (CGI-S) | Baseline to Week 8 |
| Clinical Global Impression - Global Improvement (CGI-I) score | Week 8 |
| Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score | Baseline to Week 8 |
| Number of adverse events | Baseline to Week 12 |
| Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions (1, 2, 3, 4 and 7) | Baseline to Week 8 |
| Tallinn |
| Estonia |
| FI002 | Helsinki | Finland |
| FI003 | Helsinki | Finland |
| FI005 | Helsinki | Finland |
| FI001 | Kuopio | Finland |
| FI006 | Kupio | Finland |
| FI004 | Turku | Finland |
| DE002 | Berlin | Germany |
| DE001 | Bielefeld | Germany |
| DE005 | Bochum | Germany |
| DE003 | Frankfurt | Germany |
| DE004 | Mittweida | Germany |
| RS002 | Belgrade | Serbia |
| RS001 | Kragujevac | Serbia |
| 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 |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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