A study to evaluate the cognitive effect of a product named vortioxetine (used in depression). These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2014-000229-19-EE
• Date of registration: 06/08/2014
• Prospective Registration: Yes
• Primary sponsor: H. Lundbeck A/S
• Public title: A study to evaluate the cognitive effect of a product named vortioxetine (used in depression). These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.
• Scientific 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
• Date of first enrolment: 19/09/2014
• Target sample size: 195
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000229-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Estonia, Finland, Germany, Serbia, Slovakia, Ukraine

Contacts

• Name: Lundbeck Clinical Trials
• Affiliation: H. Lundbeck A/S

• Name: Lundbeck Clinical Trials
• Affiliation: H. Lundbeck A/S

Key inclusion & exclusion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Major Depressive Disorder and cognitive impairment
MedDRA version: 17.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention(s)

Trade Name: Brintellix 10 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Current Sponsor code: Lu AA21004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Brintellix 20 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VORTIOXETINE
CAS Number: 508233-74-7
Current Sponsor code: Lu AA21004
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Cipralex 5 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ESCITALOPRAM
CAS Number: 490037-56-4
Current Sponsor code: Lu 26-054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Cipralex 10 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ESCITALOPRAM
CAS Number: 490037-56-4
Current Sponsor code: Lu 26-054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Cipralex 15 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ESCITALOPRAM
CAS Number: 490037-56-4
Current Sponsor code: Lu 26-054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Cipralex 20 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ESCITALOPRAM
CAS Number: 490037-56-4
Current Sponsor code: Lu 26-054
Concentration unit: mg

Primary Outcome(s)

Secondary Objective: To assess the efficacy of vortioxetine as adjunctive treatment to stable SSRI dose versus stable SSRI monotherapy on:
- cognitive dysfunction (performance and subjective reporting)
- depressive symptoms
- clinical global impression
- functionality

To assess the efficacy of vortioxetine as adjunctive treatment to stable SSRI dose versus vortioxetine as monotherapy on:
- cognitive dysfunction (performance and subjective reporting)
- depressive symptoms
- clinical global impression
- functionality

To assess the efficacy of vortioxetine as monotherapy versus stable SSRI monotherapy on:
- cognitive dysfunction (performance and subjective reporting)
- depressive symptoms
- clinical global impression
- functionality

To assess the safety and tolerability of vortioxetine as monotherapy and as adjunctive treatment to SSRIs

Timepoint(s) of evaluation of this end point: Throughout the study

Main Objective: 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).

Primary end point(s): Change in Digit Symbol Substitution Test (DSST)

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Throughout the study

Secondary ID(s)

15905A

Source(s) of Monetary Support

H. Lundbeck A/S