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

NCT02279953 | Completed Phase 3

• 2 other identifiers: 15905A2014-000229-19
• Study Type: interventional
• Target: 151
• Locations: 5 countries
• Sites: 17

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Digit Symbol Substitution Test (DSST): number of correct symbols

  Baseline to Week 8

Secondary Outcomes (14)

• 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

Study Arms (3)

Vortioxetine 10-20 mg

EXPERIMENTAL

daily, encapsulated, orally

Drug: Vortioxetine 10-20 mg; Drug: Placebo

Vortioxetine 10-20 mg + SSRI

EXPERIMENTAL

daily, encapsulated, orally

Drug: Vortioxetine 10-20 mg; Drug: SSRI

SSRI

EXPERIMENTAL

licensed doses, encapsulated, orally

Drug: Placebo; Drug: SSRI

Interventions

Vortioxetine 10-20 mg DRUG

Also known as: Brintellix®, Lu AA21004

Vortioxetine 10-20 mg; Vortioxetine 10-20 mg + SSRI

Placebo DRUG

SSRI; Vortioxetine 10-20 mg

SSRI DRUG

escitalopram, citalopram or sertraline

SSRI; Vortioxetine 10-20 mg + SSRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (17)

EE001

Tallinn, Estonia

Location

EE002

Tallinn, Estonia

Location

FI002

Helsinki, Finland

Location

FI003

Helsinki, Finland

Location

FI005

Helsinki, Finland

Location

FI001

Kuopio, Finland

Location

FI006

Kupio, Finland

Location

FI004

Turku, Finland

Location

DE002

Berlin, Germany

Location

DE001

Bielefeld, Germany

Location

DE005

Bochum, Germany

Location

DE003

Frankfurt, Germany

Location

DE004

Mittweida, Germany

Location

RS002

Belgrade, Serbia

Location

RS001

Kragujevac, Serbia

Location

SK003

Levice, Slovakia

Location

SK002

Rimavská Sobota, Slovakia

Location

Related Links

• Results EudraCT 2014-000229-19

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

FI (6); DE (5); SE (2); ES (2); SL (2)