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

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02279953

Collaborator

(none)

151

Enrollment

Locations

Arms

Duration (Months)

8.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition]) [Baseline to Week 8]
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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	EE001	Tallinn	Estonia
2	EE002	Tallinn	Estonia
3	FI002	Helsinki	Finland
4	FI003	Helsinki	Finland
5	FI005	Helsinki	Finland
6	FI001	Kuopio	Finland
7	FI006	Kupio	Finland
8	FI004	Turku	Finland
9	DE002	Berlin	Germany
10	DE001	Bielefeld	Germany
11	DE005	Bochum	Germany
12	DE003	Frankfurt	Germany
13	DE004	Mittweida	Germany
14	RS002	Belgrade	Serbia
15	RS001	Kragujevac	Serbia
16	SK003	Levice	Slovakia
17	SK002	Rimavska Sobota	Slovakia