Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Vortioxetine 10-20 mg; Drug: Placebo; Drug: SSRI

• Registration Number: NCT02279953
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSRI	SSRI	licensed doses, encapsulated, orally
Vortioxetine 10-20 mg + SSRI	SSRI	daily, encapsulated, orally
Vortioxetine 10-20 mg	Vortioxetine 10-20 mg	daily, encapsulated, orally
Vortioxetine 10-20 mg + SSRI	Vortioxetine 10-20 mg	daily, encapsulated, orally
SSRI	Placebo	licensed doses, encapsulated, orally
Vortioxetine 10-20 mg	Placebo	daily, encapsulated, orally

Primary Outcome Measures

Name	Time	Method
Change in Digit Symbol Substitution Test (DSST): number of correct symbols	Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Change in Trail Making Test (TMT) score: TMT-A; speed of processing	Baseline to Week 8
Change in TMT score: TMT-B; executive functioning	Baseline to Week 8
Change in reaction time score: Choice Reaction Time (CRT); attention	Baseline to Week 8
Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed	Baseline to Week 8
Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning	Baseline to Week 8
Change in STROOP: congruent score; speed of processing	Baseline to Week 8
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score	Baseline to Week 8
Change in Hamilton Depression Rating Scale-17 (HAMD-17) total score	Baseline to Week 8
Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])	Baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S)	Baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I) score	Week 8
Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score	Baseline to Week 8
Number of adverse events	Baseline to Week 12
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)	Baseline to Week 8

Trial Locations

Locations (17)

EE002; 🇪🇪 Tallinn, Estonia

RS002; 🇷🇸 Belgrade, Serbia

FI002; 🇫🇮 Helsinki, Finland

FI001; 🇫🇮 Kuopio, Finland

FI006; 🇫🇮 Kupio, Finland

FI004; 🇫🇮 Turku, Finland

SK002; 🇸🇰 Rimavska Sobota, Slovakia

FI003; 🇫🇮 Helsinki, Finland

EE001; 🇪🇪 Tallinn, Estonia

FI005; 🇫🇮 Helsinki, Finland

DE005; 🇩🇪 Bochum, Germany

DE004; 🇩🇪 Mittweida, Germany

RS001; 🇷🇸 Kragujevac, Serbia

SK003; 🇸🇰 Levice, Slovakia

DE003; 🇩🇪 Frankfurt, Germany

DE001; 🇩🇪 Bielefeld, Germany

DE002; 🇩🇪 Berlin, Germany