Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder

NCT02272517 | Completed Phase 3

• 2 other identifiers: 15907A2014-000231-16
• Study Type: interventional
• Target: 101
• Locations: 4 countries
• Sites: 16

Brief Summary

This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment.

Conditions

Major Depressive Disorder

Keywords

Vortioxetine; Cognition

Outcome Measures

Primary Outcomes (1)

• Change in Digit Symbol Substitution Test (DSST)

  The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention

  Baseline to Week 8

Secondary Outcomes (13)

• Change in Rey Auditory Verbal Learning Test (RAVLT)

  Baseline to Week 8

• Change in Trail Making Test A (TMT-A)

  Baseline to Week 8

• Change in Trail Making Test B (TMT-B)

  Baseline to Week 8

• Change in Reaction time score; CRT attention

  Baseline to Week 8

• Change in reaction time score SRT - simple reaction time

  Baseline to week 8

Study Arms (2)

Escitalopram 10-20 mg

ACTIVE COMPARATOR

Encapsulated tablets once daily for 8 weeks

Drug: Escitalopram 10-20 mg

Vortioxetine 10-20 mg

EXPERIMENTAL

Encapsulated tablets once daily for 8 weeks

Drug: Vortioxetine 10-20 mg

Interventions

Vortioxetine 10-20 mg DRUG

Also known as: Brintellix®, Lu AA21004

Vortioxetine 10-20 mg

Escitalopram 10-20 mg DRUG

Escitalopram 10-20 mg

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 DSM-IV-TR™ recurrent MDE (classification 296.3x) as confirmed using the Mini International Neuropsychiatric Interview (MINI).
• The patient has depressive symptoms currently considered as non- or only partially responsive (inadequate response), to one adequate course of SSRI/SNRI antidepressant monotherapy and is candidate for a switch in the investigator's opinion.
• The patient wants to stop taking his/her current SSRI/SNRI treatment due to inadequate response confirmed by the Antidepressant Treatment Response Questionnaire (ATRQ), \<50% response to current treatment).
• The patient must have been treated by SSRI/SNRI monotherapy (citalopram, paroxetine, sertraline, duloxetine, or venlafaxine) for at least 6 weeks at licensed doses prior to the Screening Visit.
• The patient has a PHQ-9 total score ≥14.
• The patient has a MADRS total score ≥ 22.
• The patient has had the current MDE for ≤1 year.
• The patient has a Perceived Deficits Questionnaire - Depression (PDQ-D) total score \>25.
• The patient is a man or woman aged ≥18 and ≤65 years.

You may not qualify if:

• The patient has a score ≥70 on the DSST (Number of Correct Symbols) 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 has any current psychiatric disorder or Axis I disorder (according to DSMIV-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, histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).
• The patient has history of previous MDEs considered as treatment resistant defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's judgement.
• 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 diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) (DSM-IV-TR™ criteria) that has not been in sustained full remission at least 2 years prior to the Screening Visit.
• 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 (16)

FI005

Helsinki, Finland

Location

FI001

Kuopio, Finland

Location

FI006

Kupio, Finland

Location

FI007

Tampere, Finland

Location

FI004

Turku, Finland

Location

DE005

Bochum, Germany

Location

DE004

Mittweida, Germany

Location

RS002

Belgrade, Serbia

Location

RS003

Belgrade, Serbia

Location

RS004

Belgrade, Serbia

Location

RS005

Belgrade, Serbia

Location

RS001

Kragujevac, Serbia

Location

SK004

Bratislava, Slovakia

Location

SK001

Domaša, Slovakia

Location

SK003

Levice, Slovakia

Location

SK002

Rimavská Sobota, Slovakia

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; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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 23, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

SL (4); SE (5); FI (5); DE (2)