Clinical trial NCT02279953: Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change in Digit Symbol Substitution Test (DSST): number of correct symbols
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])
timeFrame: Baseline to Week 8
measure: Change in Trail Making Test (TMT) score: TMT-A; speed of processing
timeFrame: Baseline to Week 8
measure: Change in TMT score: TMT-B; executive functioning
timeFrame: Baseline to Week 8
measure: Change in reaction time score: Choice Reaction Time (CRT); attention
timeFrame: Baseline to Week 8
measure: Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed
timeFrame: Baseline to Week 8
measure: Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning
timeFrame: Baseline to Week 8
measure: Change in STROOP: congruent score; speed of processing
timeFrame: Baseline to Week 8
measure: Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
timeFrame: Baseline to Week 8
measure: Change in Hamilton Depression Rating Scale-17 (HAMD-17) total score
timeFrame: Baseline to Week 8
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S)
timeFrame: Baseline to Week 8
measure: Clinical Global Impression - Global Improvement (CGI-I) score
timeFrame: Week 8
measure: Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
timeFrame: Baseline to Week 8
measure: Number of adverse events
timeFrame: Baseline to Week 12
measure: 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)
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: EE001
city: Tallinn
country: Estonia
facility: EE002
city: Helsinki
country: Finland
facility: FI002
city: Helsinki
country: Finland
facility: FI003
city: Helsinki
country: Finland
facility: FI005
city: Kuopio
country: Finland
facility: FI001
city: Kupio
country: Finland
facility: FI006
city: Turku
country: Finland
facility: FI004
city: Berlin
country: Germany
facility: DE002
city: Bielefeld
country: Germany
facility: DE001
city: Bochum
country: Germany
facility: DE005
city: Frankfurt
country: Germany
facility: DE003
city: Mittweida
country: Germany
facility: DE004
city: Belgrade
country: Serbia
facility: RS002
city: Kragujevac
country: Serbia
facility: RS001
city: Levice
country: Slovakia
facility: SK003
city: Rimavska Sobota
country: Slovakia
facility: SK002
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: