Major Depressive Disorder
Conditions
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).
Interventions
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Digit Symbol Substitution Test (DSST): number of correct symbols | Baseline to Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| 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 Colour Naming Test (STROOP): incongruent score; executive functioning | Baseline to Week 8 |
| Change in STROOP: congruent score; speed of processing | Baseline to Week 8 |
| Change in Trail Making Test (TMT) score: TMT-A; speed of processing | Baseline to Week 8 |
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) 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 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 |
| Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score | Baseline to Week 8 |
Countries
Estonia, Finland, Germany, Lithuania
Outcome results
None listed