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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279953
• Other study ID #: 15905A
• Secondary ID: 2014-000229-19
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2014
• Last updated: May 23, 2017
• Start date: October 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine 10-20 mg

• Placebo

• SSRI
escitalopram, citalopram or sertraline

Locations

Country	Name	City	State
Estonia	EE001	Tallinn
Estonia	EE002	Tallinn
Finland	FI002	Helsinki
Finland	FI003	Helsinki
Finland	FI005	Helsinki
Finland	FI001	Kuopio
Finland	FI006	Kupio
Finland	FI004	Turku
Germany	DE002	Berlin
Germany	DE001	Bielefeld
Germany	DE005	Bochum
Germany	DE003	Frankfurt
Germany	DE004	Mittweida
Serbia	RS002	Belgrade
Serbia	RS001	Kragujevac
Slovakia	SK003	Levice
Slovakia	SK002	Rimavska Sobota

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Estonia,  Finland,  Germany,  Serbia,  Slovakia, 

Outcome

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

External Links

•   Results EudraCT 2014-000229-19