Clinical trial NCT02272517: Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
Official title: An Interventional, Randomised, Double-blind, Parallel-group, Active-comparator, Flexible-dose Study on the Efficacy of Vortioxetine Versus Escitalopram on Cognitive Dysfunction in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Vortioxetine
Cognition
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Other protocol defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change in Digit Symbol Substitution Test (DSST)
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Baseline to Week 8
measure: Change in Trail Making Test A (TMT-A)
timeFrame: Baseline to Week 8
measure: Change in Trail Making Test B (TMT-B)
timeFrame: Baseline to Week 8
measure: Change in Reaction time score; CRT attention
timeFrame: Baseline to Week 8
measure: Change in reaction time score SRT - simple reaction time
timeFrame: Baseline to week 8
measure: Change in STROOP incongruent score
timeFrame: Baseline to Week 8
measure: Change in STROOP congruent score
timeFrame: Baseline to Week 8
measure: Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
timeFrame: Baseline to Week 8
measure: Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score
timeFrame: Baseline to Week 8
measure: Change in Clinical Global Improvement - Severity (CGI-S)
timeFrame: Baseline to Week 8
measure: Clinical Global Improvement (CGI-I)
timeFrame: Week 8
measure: Change in Functioning Assessment Short Test (FAST)
timeFrame: Baseline to Week 8
measure: Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: FI005
city: Kuopio
country: Finland
facility: FI001
city: Kupio
country: Finland
facility: FI006
city: Tampere
country: Finland
facility: FI007
city: Turku
country: Finland
facility: FI004
city: Bochum
country: Germany
facility: DE005
city: Mittweida
country: Germany
facility: DE004
city: Belgrade
country: Serbia
facility: RS002
city: Belgrade
country: Serbia
facility: RS003
city: Belgrade
country: Serbia
facility: RS004
city: Belgrade
country: Serbia
facility: RS005
city: Kragujevac
country: Serbia
facility: RS001
city: Bratislava
country: Slovakia
facility: SK004
city: Hronovce
country: Slovakia
facility: SK001
city: Levice
country: Slovakia
facility: SK003
city: Rimavska Sobota
country: Slovakia
facility: SK002
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H.Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.