A study to evaluate the cognitive effect of a product named vortioxetine (used in 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: 11 April 2016
• Main ID: EUCTR2014-000230-34-LT
• Date of registration: 29/08/2014
• 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 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, active-referenced (paroxetine), fixed-dose study on the efficacy of vortioxetine on cognitive dysfunction in working patients with major depressive disorder.
• Date of first enrolment: 05/11/2014
• Target sample size: 195
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000230-34
• 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

Countries of recruitment

Estonia, Finland, Germany, Lithuania, 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 MDD, diagnosed according to DSM-IV-TR™ recurrent major depressive disorder (MDD) (classification 296.3x).
- The patient has a MADRS total score =26.
- The patient has had the current major depressive episode (MDE) for =3 months.
- The patient is aged =18 and =65 years.
- The patient is employed full or part-time (defined as minimum 50% full time working hours per week). Part time work should not be due to a medical or mental illness other than MDD.
- The patient has been in the current job/position for at least 3 months.
- The patient has no plans to change jobs or retire within treatment period.
- The patient is not on a sick leave, and at the Screening and Randomisation Visits, there are no plans to send the patient on a sick leave.
- The patient is not receiving disability benefits.
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 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
- The patient has a score =70 on the DSST (number 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 or paroxetine.
- The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using MINI.
- The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of current episode (DSM-IV-TR™ criteria).
- The patient has borderline, schizotypal, schizoid, paranoid, or 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

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

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

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: Seroxat 10 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAROXETINE
Other descriptive name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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: Seroxat 20 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAROXETINE
Other descriptive name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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

Primary Outcome(s)

Secondary Objective: The efficacy of vortioxetine versus placebo on:
- cognitive dysfunction (performance and subjective reporting)
- depressive symptoms
- clinical global status
- functionality and quality of life
- work productivity

The proportion of the treatment effect on cognitive dysfunction, that is not attributed to an improvement in depressive symptoms.

The safety and tolerability of vortioxetine.

The efficacy and safety of the active reference (paroxetine) versus placebo on all the same parameters as mentioned for vortioxetine.

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

Main Objective: To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).

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

Secondary Outcome(s)

Secondary end point(s): - Change in Trail Making Test (TMT) score: TMT-A
- Change in 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; speed of processing
- Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
- Change in Montgomery and Aasberg Depression Rating Scale (MADRS) total score
- Change in Clinical Global Impression - Severity of Illness (CGI-S)
- Clinical Global Impression - Global Improvement (CGI-I) score
- Change in the Functioninng Assessment Short Test (FAST) total score
- Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
- Change from baseline to all visits where assessed using the MADRS and DSST
- 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)

15906A

2014-000230-34-EE

Source(s) of Monetary Support

H. Lundbeck A/S