Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT02272517
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escitalopram 10-20 mg Escitalopram 10-20 mg Encapsulated tablets once daily for 8 weeks Vortioxetine 10-20 mg Vortioxetine 10-20 mg Encapsulated tablets once daily for 8 weeks
- Primary Outcome Measures
Name Time Method Change in Digit Symbol Substitution Test (DSST) 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
Name Time Method Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score 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 Baseline to Week 8 Patient-reported outcome
Change in Rey Auditory Verbal Learning Test (RAVLT) Baseline to Week 8 Learning \[acquisition\] and memory \[delayed recall\])
Change in Trail Making Test A (TMT-A) Baseline to Week 8 Speed of processing
Change in Trail Making Test B (TMT-B) Baseline to Week 8 Executive functioning
Change in Reaction time score; CRT attention Baseline to Week 8 Change in reaction time score SRT - simple reaction time Baseline to week 8 Change in STROOP incongruent score Baseline to Week 8 Executive functioning
Change in STROOP congruent score Baseline to Week 8 Speed of processing
Change in Clinical Global Improvement - Severity (CGI-S) Baseline to Week 8 Clinical Global Improvement (CGI-I) Week 8 Change in Functioning Assessment Short Test (FAST) Baseline to Week 8 Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score Baseline to Week 8
Trial Locations
- Locations (16)
FI001
🇫🇮Kuopio, Finland
FI006
🇫🇮Kupio, Finland
FI007
🇫🇮Tampere, Finland
DE005
🇩🇪Bochum, Germany
DE004
🇩🇪Mittweida, Germany
RS001
🇷🇸Kragujevac, Serbia
RS005
🇷🇸Belgrade, Serbia
SK001
🇸🇰Hronovce, Slovakia
SK004
🇸🇰Bratislava, Slovakia
SK003
🇸🇰Levice, Slovakia
FI004
🇫🇮Turku, Finland
FI005
🇫🇮Helsinki, Finland
RS002
🇷🇸Belgrade, Serbia
RS003
🇷🇸Belgrade, Serbia
RS004
🇷🇸Belgrade, Serbia
SK002
🇸🇰Rimavska Sobota, Slovakia