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CompletedNCT02279966Updated Feb 28, 2017

Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

A Phase 3 interventional study of Vortioxetine 10 mg and Paroxetine 20 mg in Major Depressive Disorder, sponsored by H. Lundbeck A/S. Completed at 18 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Major Depressive Disorder
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 152 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive disorder (MDD) (classification 296.3x).
  • The patient has a MADRS total score ≥26.
  • The patient has had the current major depressive episode (MDE) for ≥3 months.
  • The patient is aged ≥18 and ≤65 years.
  • The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD.
  • The patient has been in the current job/position for at least 3 months.
  • The patient has no plans to change jobs or retire within treatment period.
  • The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave.
  • The patient is not receiving disability benefits.

Exclusion criteria

Exclusion criteria:

  • The patient has a score ≥70 on the DSST (number of correct symbols) at the Baseline Visit.
  • The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit.
  • The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
  • The patient is diagnosed with reading disability (dyslexia).
  • The patient has a history of lack of response to previous adequate treatment with vortioxetine or paroxetine.
  • The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using MINI.
  • The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (DSM-IV-TR™ criteria).
  • The patient has borderline, schizotypal, schizoid, paranoid, or histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).
  • The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
  • The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria).

Other protocol-defined inclusion and exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
152 participants (actual)

Study arms

  • Experimental
    Vortioxetine 10 mg

    daily, encapsulated, orally

    Drug: Vortioxetine 10 mg

  • Other
    Paroxetine 20 mg (active reference)

    daily, encapsulated, orally

    Drug: Paroxetine 20 mg

  • Placebo comparator
    Placebo

    capsules, orally

    Drug: Placebo

Interventions

  • DrugVortioxetine 10 mg

    Also known as: Brintellix®, Lu AA21004

  • DrugParoxetine 20 mg
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Change in Digit Symbol Substitution Test (DSST): number of correct symbols

    Time frame: Baseline to Week 8

Secondary outcomes

  1. Change in Trail Making Test (TMT) score: TMT-A; speed of processing

    Time frame: Baseline to Week 8

  2. Change in TMT-B; executive functioning

    Time frame: Baseline to Week 8

  3. Change in reaction time score: Choice Reaction Time (CRT); attention

    Time frame: Baseline to Week 8

  4. Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)

    Time frame: Baseline to Week 8

  5. Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning

    Time frame: Baseline to Week 8

  6. Change in STROOP: congruent score; speed of processing

    Time frame: Baseline to Week 8

  7. Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score

    Time frame: Baseline to Week 8

  8. Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score

    Time frame: Baseline to Week 8

  9. Change in Clinical Global Impression - Severity of Illness (CGI-S)

    Time frame: Baseline to Week 8

  10. Clinical Global Impression - Global Improvement (CGI-I) score

    Time frame: Week 8

  11. Change in the Functioning Assessment Short Test (FAST) total score

    Time frame: Baseline to Week 8

  12. Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score

    Time frame: Baseline to Week 8

07

Study locations

18 sites
  • EE001
    Tallinn, Estonia
  • EE002
    Tallinn, Estonia
  • EE004
    Voru, 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
    Silute, Lithuania
  • LT001
    Vilnius, Lithuania
  • LT005
    Vilnius, Lithuania
08

References and documents

Publications

  • 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. PubMed 30439678 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02279966
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Oct 31, 2014
Start date
Oct 2014
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Feb 28, 2017

Study contacts

Email contact via H. Lundbeck A/S
study director · LundbeckClinicalTrials@lundbeck.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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