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

• ClinicalTrials.gov Identifier: NCT02279966
• Recruitment Status: Completed
• First Posted: October 31, 2014
• Last Update Posted: February 28, 2017
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: Vortioxetine 10 mg; Drug: Paroxetine 20 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 2014
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vortioxetine 10 mg; daily, encapsulated, orally	Drug: Vortioxetine 10 mg; Other Names: Brintellix®; Lu AA21004
Paroxetine 20 mg (active reference); daily, encapsulated, orally	Drug: Paroxetine 20 mg
Placebo Comparator: Placebo; capsules, orally	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in Trail Making Test (TMT) score: TMT-A; speed of processing [ Time Frame: Baseline to Week 8 ]
2. Change in TMT-B; executive functioning [ Time Frame: Baseline to Week 8 ]
3. Change in reaction time score: Choice Reaction Time (CRT); attention [ Time Frame: Baseline to Week 8 ]
4. Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed) [ Time Frame: Baseline to Week 8 ]
5. Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning [ Time Frame: Baseline to Week 8 ]
6. Change in STROOP: congruent score; speed of processing [ Time Frame: Baseline to Week 8 ]
7. Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score [ Time Frame: Baseline to Week 8 ]
8. Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Baseline to Week 8 ]
9. Change in Clinical Global Impression - Severity of Illness (CGI-S) [ Time Frame: Baseline to Week 8 ]
10. Clinical Global Impression - Global Improvement (CGI-I) score [ Time Frame: Week 8 ]
11. Change in the Functioning Assessment Short Test (FAST) total score [ Time Frame: Baseline to Week 8 ]
12. Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score [ Time Frame: Baseline to Week 8 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Estonia

EE001

Tallinn, Estonia

EE002

Tallinn, Estonia

EE004

Voru, Estonia

Finland

FI002

Helsinki, Finland

FI003

Helsinki, Finland

FI001

Kuopio, Finland

FI008

Oulu, Finland

FI007

Tampere, Finland

Germany

DE002

Berlin, Germany

DE001

Bielefeld, Germany

DE003

Frankfurt, Germany

DE007

Frankfurt, Germany

DE008

Schwerin, Germany

Lithuania

LT002

Kaunas, Lithuania

LT006

Palanga, Lithuania

LT003

Silute, Lithuania

LT001

Vilnius, Lithuania

LT005

Vilnius, Lithuania

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S; LundbeckClinicalTrials@lundbeck.com

More Information

Additional Information:

EMA EudraCT Results: 2014-000230-34 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT02279966
• Other Study ID Numbers: 15906A; 2014-000230-34 ( EudraCT Number )
• First Posted: October 31, 2014
• Last Update Posted: February 28, 2017
• Last Verified: February 2017

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Cognitive Dysfunction; Mood Disorders; Mental Disorders; Behavioral Symptoms; Cognition Disorders; Neurocognitive Disorders; Vortioxetine; Paroxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT3 Receptor Antagonists