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Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of 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: NCT02279953
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning and attention) in patients who are in partial or full remission from their Major Depressive Episode (MDE).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 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 Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
Study Start Date : October 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vortioxetine 10-20 mg
daily, encapsulated, orally
Drug: Vortioxetine 10-20 mg
Other Names:
  • Brintellix®
  • Lu AA21004

Drug: Placebo
Experimental: Vortioxetine 10-20 mg + SSRI
daily, encapsulated, orally
Drug: Vortioxetine 10-20 mg
Other Names:
  • Brintellix®
  • Lu AA21004

Drug: SSRI
escitalopram, citalopram or sertraline

Experimental: SSRI
licensed doses, encapsulated, orally
Drug: Placebo
Drug: SSRI
escitalopram, citalopram or sertraline




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 Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition]) [ Time Frame: Baseline to Week 8 ]
  2. Change in Trail Making Test (TMT) score: TMT-A; speed of processing [ Time Frame: Baseline to Week 8 ]
  3. Change in TMT score: TMT-B; executive functioning [ Time Frame: Baseline to Week 8 ]
  4. Change in reaction time score: Choice Reaction Time (CRT); attention [ Time Frame: Baseline to Week 8 ]
  5. Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed [ Time Frame: Baseline to Week 8 ]
  6. Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning [ Time Frame: Baseline to Week 8 ]
  7. Change in STROOP: congruent score; speed of processing [ Time Frame: Baseline to Week 8 ]
  8. Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score [ Time Frame: Baseline to Week 8 ]
  9. Change in Hamilton Depression Rating Scale-17 (HAMD-17) total score [ Time Frame: Baseline to Week 8 ]
  10. Change in Clinical Global Impression - Severity of Illness (CGI-S) [ Time Frame: Baseline to Week 8 ]
  11. Clinical Global Impression - Global Improvement (CGI-I) score [ Time Frame: Week 8 ]
  12. Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score [ Time Frame: Baseline to Week 8 ]
  13. Number of adverse events [ Time Frame: Baseline to Week 12 ]
  14. Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions (1, 2, 3, 4 and 7) [ 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 achieved either partial (some symptoms of a MDE are present but full criteria are not met) or full remission of major depressive disorder (MDD), diagnosed according to DSM-IV-TR™.
  • The patient has HAMD-17 total score ≤10.
  • The patient has received SSRI monotherapy for the MDE from which the patient is currently in full or partial remission for ≥12 weeks at licensed doses and been on stable dose ≥8 weeks prior to Screening Visit.
  • The patient has ≥50% response to current SSRI treatment (Antidepressant Treatment Response Questionnaire [ATRQ]).
  • The patient has a PDQ-D total score >25.
  • The patient is a man or woman, aged ≥18 and ≤65 years.

Exclusion Criteria:

  • The patient has a score ≥70 on the DSST (numbers 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.
  • The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using Mini International Neuropsychiatric Interview (MINI).
  • The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of the depressive episode from which the patient is currently in full or partial remission (DSM-IV-TR™ criteria).
  • The patient has borderline, schizotypal, schizoid, paranoid, 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): NCT02279953


Locations
Show Show 17 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:
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02279953    
Other Study ID Numbers: 15905A
2014-000229-19 ( EudraCT Number )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 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
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists