Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000230-34 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vortioxetine 10 mg | Experimental | daily, encapsulated, orally |
|
| Paroxetine 20 mg (active reference) | Other | daily, encapsulated, orally |
|
| Placebo | Placebo Comparator | capsules, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine 10 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 Trail Making Test (TMT) score: TMT-A; speed of processing | Baseline to Week 8 | |
| Change in TMT-B; executive functioning | Baseline to Week 8 | |
| Change in reaction time score: Choice Reaction Time (CRT); attention |
Not provided
Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paroxetine 20 mg |
| Drug |
|
| Placebo | Drug |
|
| 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 Montgomery and Asberg Depression Rating Scale (MADRS) 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 the Functioning Assessment Short Test (FAST) total score | Baseline to Week 8 |
| Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score | Baseline to Week 8 |
| Tallinn |
| Estonia |
| EE004 | Võru | Estonia |
| FI002 | Helsinki | Finland |
| FI003 | Helsinki | Finland |
| FI001 | Kuopio | Finland |
| FI008 | Oulu | Finland |
| FI007 | Tampere | Finland |
| DE002 | Berlin | Germany |
| DE001 | Bielefeld | Germany |
| DE003 | Frankfurt | Germany |
| DE007 | Frankfurt | Germany |
| DE008 | Schwerin | Germany |
| LT002 | Kaunas | Lithuania |
| LT006 | Palanga | Lithuania |
| LT003 | Šilutė | Lithuania |
| LT001 | Vilnius | Lithuania |
| LT005 | Vilnius | Lithuania |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
Not provided
Not provided