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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272517


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02272517     History of Changes
Other Study ID Numbers: 15907A
2014-000231-16 ( EudraCT Number )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by H. Lundbeck A/S:
Vortioxetine
Cognition

Additional relevant MeSH terms:
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Dexetimide
Citalopram
Muscarinic Antagonists
Cholinergic Antagonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents