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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02279966
• Date of registration: 21/10/2014
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 152
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02279966
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Estonia, Finland, Germany, Lithuania

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Placebo

Drug: Paroxetine 20 mg

Drug: Vortioxetine 10 mg

Primary Outcome(s)

Change in Digit Symbol Substitution Test (DSST): number of correct symbols [Time Frame: Baseline to Week 8]

Secondary Outcome(s)

Change in reaction time score: Choice Reaction Time (CRT); attention [Time Frame: Baseline to Week 8]

Clinical Global Impression - Global Improvement (CGI-I) score [Time Frame: Week 8]

Change in STROOP: congruent score; speed of processing [Time Frame: Baseline to Week 8]

Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score [Time Frame: Baseline to Week 8]

Change in the Functioning Assessment Short Test (FAST) total score [Time Frame: Baseline to Week 8]

Change in Clinical Global Impression - Severity of Illness (CGI-S) [Time Frame: Baseline to Week 8]

Change in TMT-B; executive functioning [Time Frame: Baseline to Week 8]

Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score [Time Frame: Baseline to Week 8]

Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning [Time Frame: Baseline to Week 8]

Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed) [Time Frame: Baseline to Week 8]

Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score [Time Frame: Baseline to Week 8]

Change in Trail Making Test (TMT) score: TMT-A; speed of processing [Time Frame: Baseline to Week 8]

Secondary ID(s)

15906A

2014-000230-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors