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

H. Lundbeck A/S18 sites in 4 countries152 target enrollmentOctober 2014

ConditionsMajor Depressive Disorder

InterventionsVortioxetine 10 mg Paroxetine 20 mg Placebo

DrugsVortioxetine 10 mg Paroxetine 20 mg Placebo

Overview

Phase: Phase 3
Intervention: Vortioxetine 10 mg
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Enrollment: 152
Locations: 18
Primary Endpoint: Change in Digit Symbol Substitution Test (DSST): number of correct symbols
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

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 ≥
•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:

Exclusion Criteria

Not provided

Arms & Interventions

Vortioxetine 10 mg

daily, encapsulated, orally

Intervention: Vortioxetine 10 mg

Paroxetine 20 mg (active reference)

daily, encapsulated, orally

Intervention: Paroxetine 20 mg

Placebo

capsules, orally

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Digit Symbol Substitution Test (DSST): number of correct symbols

Time Frame: Baseline to Week 8

Secondary Outcomes

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)