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
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|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Vortioxetine 10-20 mg Drug: Escitalopram 10-20 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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
- Change in Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline to Week 8 ]Learning [acquisition] and memory [delayed recall])
- Change in Trail Making Test A (TMT-A) [ Time Frame: Baseline to Week 8 ]Speed of processing
- Change in Trail Making Test B (TMT-B) [ Time Frame: Baseline to Week 8 ]Executive functioning
- Change in Reaction time score; CRT attention [ Time Frame: Baseline to Week 8 ]
- Change in reaction time score SRT - simple reaction time [ Time Frame: Baseline to week 8 ]
- Change in STROOP incongruent score [ Time Frame: Baseline to Week 8 ]Executive functioning
- Change in STROOP congruent score [ Time Frame: Baseline to Week 8 ]Speed of processing
- 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
- Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score [ Time Frame: Baseline to Week 8 ]Patient-reported outcome
- Change in Clinical Global Improvement - Severity (CGI-S) [ Time Frame: Baseline to Week 8 ]
- Clinical Global Improvement (CGI-I) [ Time Frame: Week 8 ]
- Change in Functioning Assessment Short Test (FAST) [ Time Frame: Baseline to Week 8 ]
- Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score [ Time Frame: Baseline to Week 8 ]
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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|
- 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.
- 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.
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
|Rimavska Sobota, Slovakia|
|Study Director:||Email contact via H.Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||H. Lundbeck A/S|
|Other Study ID Numbers:||
2014-000231-16 ( EudraCT Number )
|First Posted:||October 23, 2014 Key Record Dates|
|Last Update Posted:||February 28, 2017|
|Last Verified:||February 2017|
Depressive Disorder, Major
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Depressants
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists