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

• ClinicalTrials.gov Identifier: NCT02272517
• Recruitment Status: Completed
• First Posted: October 23, 2014
• Last Update Posted: February 28, 2017
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: Vortioxetine 10-20 mg; Drug: Escitalopram 10-20 mg	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Escitalopram 10-20 mg; Encapsulated tablets once daily for 8 weeks	Drug: Escitalopram 10-20 mg
Experimental: Vortioxetine 10-20 mg; Encapsulated tablets once daily for 8 weeks	Drug: Vortioxetine 10-20 mg; Other Names: Brintellix®; Lu AA21004

Outcome Measures

Primary Outcome Measures :

1. Change in Digit Symbol Substitution Test (DSST) [ Time Frame: Baseline to Week 8 ]
   The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Finland

FI005

Helsinki, Finland

FI001

Kuopio, Finland

FI006

Kupio, Finland

FI007

Tampere, Finland

FI004

Turku, Finland

Germany

DE005

Bochum, Germany

DE004

Mittweida, Germany

Serbia

RS002

Belgrade, Serbia

RS003

Belgrade, Serbia

RS004

Belgrade, Serbia

RS005

Belgrade, Serbia

RS001

Kragujevac, Serbia

Slovakia

SK004

Bratislava, Slovakia

SK001

Hronovce, Slovakia

SK003

Levice, Slovakia

SK002

Rimavska Sobota, Slovakia

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact via H.Lundbeck A/S; LundbeckClinicalTrials@lundbeck.com

More Information

Additional Information:

EMA EudraCT Results: 2014-000230-34 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT02272517
• Other Study ID Numbers: 15907A; 2014-000231-16 ( EudraCT Number )
• First Posted: October 23, 2014
• Last Update Posted: February 28, 2017
• Last Verified: February 2017

Keywords provided by H. Lundbeck A/S:

Vortioxetine; Cognition

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Vortioxetine; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists