Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced (Paroxetine), Fixed-dose Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279966
• Other study ID #: 15906A
• Secondary ID: 2014-000230-34
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2014
• Last updated: February 27, 2017
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patient has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™) recurrent major depressive disorder (MDD) (classification 296.3x).

• The patient has a MADRS total score =26.

• The patient has had the current major depressive episode (MDE) for =3 months.

• The patient is aged =18 and =65 years.

• The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD.

• The patient has been in the current job/position for at least 3 months.

• The patient has no plans to change jobs or retire within treatment period.

• The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave.

• The patient is not receiving disability benefits.

Exclusion criteria:

• The patient has a score =70 on the DSST (number of correct symbols) at the Baseline Visit.

• The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly 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 is diagnosed with reading disability (dyslexia).

• The patient has a history of lack of response to previous adequate treatment with vortioxetine or paroxetine.

• The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-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, or histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).

• 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 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine 10 mg

• Paroxetine 20 mg

• Placebo

Locations

Country	Name	City	State
Estonia	EE001	Tallinn
Estonia	EE002	Tallinn
Estonia	EE004	Voru
Finland	FI002	Helsinki
Finland	FI003	Helsinki
Finland	FI001	Kuopio
Finland	FI008	Oulu
Finland	FI007	Tampere
Germany	DE002	Berlin
Germany	DE001	Bielefeld
Germany	DE003	Frankfurt
Germany	DE007	Frankfurt
Germany	DE008	Schwerin
Lithuania	LT002	Kaunas
Lithuania	LT006	Palanga
Lithuania	LT003	Silute
Lithuania	LT001	Vilnius
Lithuania	LT005	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Estonia,  Finland,  Germany,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Digit Symbol Substitution Test (DSST): number of correct symbols		Baseline to Week 8
Secondary	Change in Trail Making Test (TMT) score: TMT-A; speed of processing		Baseline to Week 8
Secondary	Change in TMT-B; executive functioning		Baseline to Week 8
Secondary	Change in reaction time score: Choice Reaction Time (CRT); attention		Baseline to Week 8
Secondary	Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)		Baseline to Week 8
Secondary	Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning		Baseline to Week 8
Secondary	Change in STROOP: congruent score; speed of processing		Baseline to Week 8
Secondary	Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score		Baseline to Week 8
Secondary	Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score		Baseline to Week 8
Secondary	Change in Clinical Global Impression - Severity of Illness (CGI-S)		Baseline to Week 8
Secondary	Clinical Global Impression - Global Improvement (CGI-I) score		Week 8
Secondary	Change in the Functioning Assessment Short Test (FAST) total score		Baseline to Week 8
Secondary	Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score		Baseline to Week 8

External Links

•   EMA EudraCT Results: 2014-000230-34