Clinical trial NCT02279966: Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 ≥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.

Primary outcomes:
measure: Change in Digit Symbol Substitution Test (DSST): number of correct symbols
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Trail Making Test (TMT) score: TMT-A; speed of processing
timeFrame: Baseline to Week 8
measure: Change in TMT-B; executive functioning
timeFrame: Baseline to Week 8
measure: Change in reaction time score: Choice Reaction Time (CRT); attention
timeFrame: Baseline to Week 8
measure: Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)
timeFrame: Baseline to Week 8
measure: Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning
timeFrame: Baseline to Week 8
measure: Change in STROOP: congruent score; speed of processing
timeFrame: Baseline to Week 8
measure: Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
timeFrame: Baseline to Week 8
measure: Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score
timeFrame: Baseline to Week 8
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S)
timeFrame: Baseline to Week 8
measure: Clinical Global Impression - Global Improvement (CGI-I) score
timeFrame: Week 8
measure: Change in the Functioning Assessment Short Test (FAST) total score
timeFrame: Baseline to Week 8
measure: Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: EE001
city: Tallinn
country: Estonia
facility: EE002
city: Voru
country: Estonia
facility: EE004
city: Helsinki
country: Finland
facility: FI002
city: Helsinki
country: Finland
facility: FI003
city: Kuopio
country: Finland
facility: FI001
city: Oulu
country: Finland
facility: FI008
city: Tampere
country: Finland
facility: FI007
city: Berlin
country: Germany
facility: DE002
city: Bielefeld
country: Germany
facility: DE001
city: Frankfurt
country: Germany
facility: DE003
city: Frankfurt
country: Germany
facility: DE007
city: Schwerin
country: Germany
facility: DE008
city: Kaunas
country: Lithuania
facility: LT002
city: Palanga
country: Lithuania
facility: LT006
city: Silute
country: Lithuania
facility: LT003
city: Vilnius
country: Lithuania
facility: LT001
city: Vilnius
country: Lithuania
facility: LT005
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.