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

NCT ID: NCT02272517

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Escitalopram 10-20 mg

Encapsulated tablets once daily for 8 weeks

Group Type: ACTIVE_COMPARATOR

Escitalopram 10-20 mg

Intervention Type: DRUG

Vortioxetine 10-20 mg

Encapsulated tablets once daily for 8 weeks

Group Type: EXPERIMENTAL

Vortioxetine 10-20 mg

Intervention Type: DRUG

Interventions

Vortioxetine 10-20 mg

Intervention Type: DRUG

Escitalopram 10-20 mg

Intervention Type: DRUG

Other Intervention Names

Brintellix®; Lu AA21004

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H.Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

FI005

Helsinki, , Finland

FI001

Kuopio, , Finland

FI006

Kupio, , Finland

FI007

Tampere, , Finland

FI004

Turku, , Finland

DE005

Bochum, , Germany

DE004

Mittweida, , Germany

RS002

Belgrade, , Serbia

RS003

Belgrade, , Serbia

RS004

Belgrade, , Serbia

RS005

Belgrade, , Serbia

RS001

Kragujevac, , Serbia

SK004

Bratislava, , Slovakia

SK001

Domaša, , Slovakia

SK003

Levice, , Slovakia

SK002

Rimavská Sobota, , Slovakia

Countries

Finland; Germany; Serbia; Slovakia

References

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.

Reference Type: DERIVED

PMID: 30439678 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000230-34/results

EMA EudraCT Results: 2014-000230-34

Other Identifiers

2014-000231-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15907A

Identifier Type: -

Identifier Source: org_study_id