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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Paroxetine 20 mg; Drug: Vortioxetine 10 mg

• Registration Number: NCT02279966
• Lead Sponsor: H. Lundbeck A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	capsules, orally
Paroxetine 20 mg (active reference)	Paroxetine 20 mg	daily, encapsulated, orally
Vortioxetine 10 mg	Vortioxetine 10 mg	daily, encapsulated, orally

Primary Outcome Measures

Name	Time	Method
Change in Digit Symbol Substitution Test (DSST): number of correct symbols	Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Change in Trail Making Test (TMT) score: TMT-A; speed of processing	Baseline to Week 8
Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning	Baseline to Week 8
Change in TMT-B; executive functioning	Baseline to Week 8
Change in reaction time score: Choice Reaction Time (CRT); attention	Baseline to Week 8
Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)	Baseline to Week 8
Change in STROOP: congruent score; speed of processing	Baseline to Week 8
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score	Baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S)	Baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I) score	Week 8
Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score	Baseline to Week 8
Change in the Functioning Assessment Short Test (FAST) total score	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 (18)

FI003; 🇫🇮 Helsinki, Finland

LT005; 🇱🇹 Vilnius, Lithuania

EE001; 🇪🇪 Tallinn, Estonia

EE002; 🇪🇪 Tallinn, Estonia

EE004; 🇪🇪 Voru, Estonia

FI002; 🇫🇮 Helsinki, Finland

FI001; 🇫🇮 Kuopio, Finland

FI008; 🇫🇮 Oulu, Finland

FI007; 🇫🇮 Tampere, Finland

DE002; 🇩🇪 Berlin, Germany

DE007; 🇩🇪 Frankfurt, Germany

DE008; 🇩🇪 Schwerin, Germany

DE003; 🇩🇪 Frankfurt, Germany

LT002; 🇱🇹 Kaunas, Lithuania

LT006; 🇱🇹 Palanga, Lithuania

LT003; 🇱🇹 Silute, Lithuania

LT001; 🇱🇹 Vilnius, Lithuania

DE001; 🇩🇪 Bielefeld, Germany