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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272517
• Other study ID #: 15907A
• Secondary ID: 2014-000231-16
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2014
• Last updated: February 27, 2017
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine 10-20 mg

• Escitalopram 10-20 mg

Locations

Country	Name	City	State
Finland	FI005	Helsinki
Finland	FI001	Kuopio
Finland	FI006	Kupio
Finland	FI007	Tampere
Finland	FI004	Turku
Germany	DE005	Bochum
Germany	DE004	Mittweida
Serbia	RS002	Belgrade
Serbia	RS003	Belgrade
Serbia	RS004	Belgrade
Serbia	RS005	Belgrade
Serbia	RS001	Kragujevac
Slovakia	SK004	Bratislava
Slovakia	SK001	Hronovce
Slovakia	SK003	Levice
Slovakia	SK002	Rimavska Sobota

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Finland,  Germany,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Rey Auditory Verbal Learning Test (RAVLT)	Learning [acquisition] and memory [delayed recall])	Baseline to Week 8
Secondary	Change in Trail Making Test A (TMT-A)	Speed of processing	Baseline to Week 8
Secondary	Change in Trail Making Test B (TMT-B)	Executive functioning	Baseline to Week 8
Secondary	Change in Reaction time score; CRT attention		Baseline to Week 8
Secondary	Change in reaction time score SRT - simple reaction time		Baseline to week 8
Secondary	Change in STROOP incongruent score	Executive functioning	Baseline to Week 8
Secondary	Change in STROOP congruent score	Speed of processing	Baseline to Week 8
Secondary	Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score	Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization	Baseline to Week 8
Secondary	Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score	Patient-reported outcome	Baseline to Week 8
Secondary	Change in Clinical Global Improvement - Severity (CGI-S)		Baseline to Week 8
Secondary	Clinical Global Improvement (CGI-I)		Week 8
Secondary	Change in Functioning Assessment Short Test (FAST)		Baseline to Week 8
Secondary	Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score		Baseline to Week 8

External Links

•   EMA EudraCT Results: 2014-000230-34