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

NCT ID: NCT02279953

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vortioxetine 10-20 mg

daily, encapsulated, orally

Group Type: EXPERIMENTAL

Vortioxetine 10-20 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Vortioxetine 10-20 mg + SSRI

daily, encapsulated, orally

Group Type: EXPERIMENTAL

Vortioxetine 10-20 mg

Intervention Type: DRUG

SSRI

Intervention Type: DRUG

escitalopram, citalopram or sertraline

SSRI

licensed doses, encapsulated, orally

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

SSRI

Intervention Type: DRUG

escitalopram, citalopram or sertraline

Interventions

Vortioxetine 10-20 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

SSRI

escitalopram, citalopram or sertraline

Intervention Type: DRUG

Other Intervention Names

Brintellix®; Lu AA21004

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

EE001

Tallinn, , Estonia

EE002

Tallinn, , Estonia

FI002

Helsinki, , Finland

FI003

Helsinki, , Finland

FI005

Helsinki, , Finland

FI001

Kuopio, , Finland

FI006

Kupio, , Finland

FI004

Turku, , Finland

DE002

Berlin, , Germany

DE001

Bielefeld, , Germany

DE005

Bochum, , Germany

DE003

Frankfurt, , Germany

DE004

Mittweida, , Germany

RS002

Belgrade, , Serbia

RS001

Kragujevac, , Serbia

SK003

Levice, , Slovakia

SK002

Rimavská Sobota, , Slovakia

Countries

Estonia; Finland; Germany; Serbia; Slovakia

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000229-19/results

Results EudraCT 2014-000229-19

Other Identifiers

2014-000229-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15905A

Identifier Type: -

Identifier Source: org_study_id