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

NCT02279966 | Completed Phase 3

• 2 other identifiers: 15906A2014-000230-34
• Study Type: interventional
• Target: 152
• Locations: 4 countries
• Sites: 18

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) in working patients with major depressive disorder (MDD).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 8

Secondary Outcomes (12)

• 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

  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

Study Arms (3)

Vortioxetine 10 mg

EXPERIMENTAL

daily, encapsulated, orally

Drug: Vortioxetine 10 mg

Paroxetine 20 mg (active reference)

OTHER

daily, encapsulated, orally

Drug: Paroxetine 20 mg

Placebo

PLACEBO COMPARATOR

capsules, orally

Drug: Placebo

Interventions

Vortioxetine 10 mg DRUG

Also known as: Brintellix®, Lu AA21004

Vortioxetine 10 mg

Paroxetine 20 mg DRUG

Paroxetine 20 mg (active reference)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (18)

EE001

Tallinn, Estonia

Location

EE002

Tallinn, Estonia

Location

EE004

Võru, Estonia

Location

FI002

Helsinki, Finland

Location

FI003

Helsinki, Finland

Location

FI001

Kuopio, Finland

Location

FI008

Oulu, Finland

Location

FI007

Tampere, Finland

Location

DE002

Berlin, Germany

Location

DE001

Bielefeld, Germany

Location

DE003

Frankfurt, Germany

Location

DE007

Frankfurt, Germany

Location

DE008

Schwerin, Germany

Location

LT002

Kaunas, Lithuania

Location

LT006

Palanga, Lithuania

Location

LT003

Šilutė, Lithuania

Location

LT001

Vilnius, Lithuania

Location

LT005

Vilnius, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 30439678 DERIVED

Related Links

• EMA EudraCT Results: 2014-000230-34

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine; Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

DE (5); LI (5); FI (5); ES (3)