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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279966
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

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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


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



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 ]


Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279966


Locations
Show Show 18 study locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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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