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Status:

COMPLETED

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

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief 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) ...

Eligibility Criteria

Inclusion

  • 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:
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2016

    Estimated Enrollment :

    152 Patients enrolled

    Trial Details

    Trial ID

    NCT02279966

    Start Date

    October 1 2014

    End Date

    February 1 2016

    Last Update

    February 28 2017

    Active Locations (18)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (18 locations)

    1

    EE001

    Tallinn, Estonia

    2

    EE002

    Tallinn, Estonia

    3

    EE004

    Võru, Estonia

    4

    FI002

    Helsinki, Finland