Major Depressive DisorderPhase 3NCT02272517
Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
A Phase 3 study testing Vortioxetine 10-20 mg and Escitalopram 10-20 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 16 sites in 4 countries.
Trial summary
This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Vortioxetine 10-20 mg and Escitalopram 10-20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Dec 2014to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has MDD, diagnosed according to DSM-IV-TR™ recurrent MDE (classification 296.3x) as confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has depressive symptoms currently considered as non- or only partially responsive (inadequate response), to one adequate course of SSRI/SNRI antidepressant monotherapy and is candidate for a switch in the investigator's opinion.
- The patient wants to stop taking his/her current SSRI/SNRI treatment due to inadequate response confirmed by the Antidepressant Treatment Response Questionnaire (ATRQ), <50% response to current treatment).
- The patient must have been treated by SSRI/SNRI monotherapy (citalopram, paroxetine, sertraline, duloxetine, or venlafaxine) for at least 6 weeks at licensed doses prior to the Screening Visit.
- The patient has a PHQ-9 total score ≥14.
- The patient has a MADRS total score ≥ 22.
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- The patient has had the current MDE for ≤1 year.
- The patient has a Perceived Deficits Questionnaire - Depression (PDQ-D) total score >25.
- The patient is a man or woman aged ≥18 and ≤65 years.
Who cannot join
- The patient has a score ≥70 on the DSST (Number of Correct Symbols) 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 has any current psychiatric disorder or Axis I disorder (according to DSMIV-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, histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).
- The patient has history of previous MDEs considered as treatment resistant defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's judgement.
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- 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 diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) (DSM-IV-TR™ criteria) that has not been in sustained full remission at least 2 years prior to the Screening Visit.
- 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.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Serbia5 sites
RS002
Belgrade
RS003
Belgrade
RS004
Belgrade
RS005
Belgrade
RS001
Kragujevac
Slovakia4 sites
SK004
Bratislava
SK001
Domaša
SK003
Levice
SK002
Rimavská Sobota
About this study
Official title: An Interventional, Randomised, Double-blind, Parallel-group, Active-comparator, Flexible-dose Study on the Efficacy of Vortioxetine Versus Escitalopram on Cognitive Dysfunction in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine 10-20 mg, Escitalopram 10-20 mg
- Keywords
- Vortioxetine, Cognition
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortioxetine 10-20 mgDrug
Also called Brintellix®, Lu AA21004
Escitalopram 10-20 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram 10-20 mg | Active comparator | Encapsulated tablets once daily for 8 weeks Receives: Drug: Escitalopram 10-20 mg |
| Vortioxetine 10-20 mg | Experimental | Encapsulated tablets once daily for 8 weeks Receives: Drug: Vortioxetine 10-20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Digit Symbol Substitution Test (DSST)
The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention
Measured: Baseline to Week 8
Secondary outcomes (13)
Change in Rey Auditory Verbal Learning Test (RAVLT)
Learning [acquisition] and memory [delayed recall])
Measured: Baseline to Week 8
Change in Trail Making Test A (TMT-A)
Speed of processing
Measured: Baseline to Week 8
Change in Trail Making Test B (TMT-B)
Executive functioning
Measured: Baseline to Week 8
Change in Reaction time score; CRT attention
Measured: Baseline to Week 8
Change in reaction time score SRT - simple reaction time
Measured: Baseline to week 8
Change in STROOP incongruent score
Executive functioning
Measured: Baseline to Week 8
Change in STROOP congruent score
Speed of processing
Measured: Baseline to Week 8
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization
Measured: Baseline to Week 8
Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score
Patient-reported outcome
Measured: Baseline to Week 8
Change in Clinical Global Improvement - Severity (CGI-S)
Measured: Baseline to Week 8
Clinical Global Improvement (CGI-I)
Measured: Week 8
Change in Functioning Assessment Short Test (FAST)
Measured: Baseline to Week 8
Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H.Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272517
- Sponsor's protocol ID
- 15907A
- Other IDs
- 2014-000231-16, 2014
- Status last verified
- Feb 2017
- First submitted
- 21 Oct 2014
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Christensen MC, Sluth LB, McIntyre RS. Validation of the University of California San Diego Performance-based Skills Assessment (UPSA) in major depressive disorder: Replication and extension of initial findings. J Affect Disord. 2019 Feb 15;245:508-516. doi: 10.1016/j.jad.2018.11.034. Epub 2018 Nov 5.
PubMed 30439678
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Randomised, Double-blind, Parallel-group, Active-comparator, Flexible-dose Study on the Efficacy of Vortioxetine Versus Escitalopram on Cognitive Dysfunction in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02272517
- Acronym / sponsor ID
- 15907A
- Conditions
- Major Depressive Disorder
- Keywords
- Vortioxetine, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram 10-20 mg | Active comparator | Drug: Escitalopram 10-20 mgEncapsulated tablets once daily for 8 weeks |
| Vortioxetine 10-20 mg | Experimental | Drug: Vortioxetine 10-20 mgEncapsulated tablets once daily for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient has MDD, diagnosed according to DSM-IV-TR™ recurrent MDE (classification 296.3x) as confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has depressive symptoms currently considered as non- or only partially responsive (inadequate response), to one adequate course of SSRI/SNRI antidepressant monotherapy and is candidate for a switch in the investigator's opinion.
- The patient wants to stop taking his/her current SSRI/SNRI treatment due to inadequate response confirmed by the Antidepressant Treatment Response Questionnaire (ATRQ), <50% response to current treatment).
- The patient must have been treated by SSRI/SNRI monotherapy (citalopram, paroxetine, sertraline, duloxetine, or venlafaxine) for at least 6 weeks at licensed doses prior to the Screening Visit.
- The patient has a PHQ-9 total score ≥14.
Key exclusion criteria (10 listed)
- The patient has a score ≥70 on the DSST (Number of Correct Symbols) 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 has any current psychiatric disorder or Axis I disorder (according to DSMIV-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, histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vortioxetine 10-20 mgAlso: Brintellix®, Lu AA21004 | Drug | Vortioxetine 10-20 mg |
| Escitalopram 10-20 mg | Drug | Escitalopram 10-20 mg |
Primary outcome
Change in Digit Symbol Substitution Test (DSST)
Time frame: Baseline to Week 8
The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention
13 secondary outcomes
Change in Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline to Week 8
Change in Trail Making Test A (TMT-A)
Time frame: Baseline to Week 8
Change in Trail Making Test B (TMT-B)
Time frame: Baseline to Week 8
Change in Reaction time score; CRT attention
Time frame: Baseline to Week 8
Change in reaction time score SRT - simple reaction time
Time frame: Baseline to week 8
Change in STROOP incongruent score
Time frame: Baseline to Week 8
Change in STROOP congruent score
Time frame: Baseline to Week 8
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
Time frame: Baseline to Week 8
Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score
Time frame: Baseline to Week 8
Change in Clinical Global Improvement - Severity (CGI-S)
Time frame: Baseline to Week 8
Clinical Global Improvement (CGI-I)
Time frame: Week 8
Change in Functioning Assessment Short Test (FAST)
Time frame: Baseline to Week 8
Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
Time frame: Baseline to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Derived from this study: PubMed 30439678Christensen MC, Sluth LB, McIntyre RS. Validation of the University of California San Diego Performance-based Skills Assessment (UPSA) in major depressive disorder: Replication and extension of initial findings. J Affect Disord. 2019 Feb 15;245:508-516. doi: 10.1016/j.jad.2018.11.034. Epub 2018 Nov 5.
- EMA EudraCT Results: 2014-000230-34Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H.Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vortioxetine 10-20 mg and Escitalopram 10-20 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Finland, Serbia, Slovakia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Digit Symbol Substitution Test (DSST) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02272517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.