Major Depressive DisorderPhase 3NCT02279966
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
A Phase 3 study testing Vortioxetine 10 mg and Paroxetine 20 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 18 sites in 4 countries.
Trial summary
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). 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 mg and Paroxetine 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Oct 2014to Feb 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 Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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).
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Finland5 sites
FI002
Helsinki
FI003
Helsinki
FI001
Kuopio
FI008
Oulu
FI007
Tampere
Germany5 sites
DE002
Berlin
DE001
Bielefeld
DE003
Frankfurt
DE007
Frankfurt
DE008
Schwerin
Lithuania5 sites
LT002
Kaunas
LT006
Palanga
LT003
Šilutė
LT001
Vilnius
LT005
Vilnius
About this study
Official 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
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).
- Conditions
- Major Depressive Disorder
- Being tested
- Vortioxetine 10 mg, Paroxetine 20 mg, Placebo
- 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 mgDrug
Also called Brintellix®, Lu AA21004
Paroxetine 20 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine 10 mg | Experimental | daily, encapsulated, orally Receives: Drug: Vortioxetine 10 mg |
| Paroxetine 20 mg (active reference) | Other | daily, encapsulated, orally Receives: Drug: Paroxetine 20 mg |
| Placebo | Placebo comparator | capsules, orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Digit Symbol Substitution Test (DSST): number of correct symbols
Measured: Baseline to Week 8
Secondary outcomes (12)
Change in Trail Making Test (TMT) score: TMT-A; speed of processing
Measured: Baseline to Week 8
Change in TMT-B; executive functioning
Measured: Baseline to Week 8
Change in reaction time score: Choice Reaction Time (CRT); attention
Measured: Baseline to Week 8
Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)
Measured: Baseline to Week 8
Change in Stroop Colour Naming Test (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
Measured: Baseline to Week 8
Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score
Measured: Baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S)
Measured: Baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I) score
Measured: Week 8
Change in the Functioning Assessment Short Test (FAST) total score
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 posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 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
- 152 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
- NCT02279966
- Sponsor's protocol ID
- 15906A
- Other IDs
- 2014-000230-34, 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, Placebo-controlled, Active-referenced (Paroxetine), Fixed-dose Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02279966
- Acronym / sponsor ID
- 15906A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 31 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine 10 mg | Experimental | Drug: Vortioxetine 10 mgdaily, encapsulated, orally |
| Paroxetine 20 mg (active reference) | Other | Drug: Paroxetine 20 mgdaily, encapsulated, orally |
| Placebo | Placebo comparator | Drug: Placebocapsules, orally |
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 Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (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.
Key exclusion criteria (11 listed)
- 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.
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 mgAlso: Brintellix®, Lu AA21004 | Drug | Vortioxetine 10 mg |
| Paroxetine 20 mg | Drug | Paroxetine 20 mg (active reference) |
| Placebo | Drug | Placebo |
Primary outcome
Change in Digit Symbol Substitution Test (DSST): number of correct symbols
Time frame: Baseline to Week 8
12 secondary outcomes
Change in Trail Making Test (TMT) score: TMT-A; speed of processing
Time frame: Baseline to Week 8
Change in TMT-B; executive functioning
Time frame: Baseline to Week 8
Change in reaction time score: Choice Reaction Time (CRT); attention
Time frame: Baseline to Week 8
Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)
Time frame: Baseline to Week 8
Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning
Time frame: Baseline to Week 8
Change in STROOP: congruent score; speed of processing
Time frame: Baseline to Week 8
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
Time frame: Baseline to Week 8
Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score
Time frame: Baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S)
Time frame: Baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I) score
Time frame: Week 8
Change in the Functioning Assessment Short Test (FAST) total score
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.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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
18 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 mg and Paroxetine 20 mg in people with Major Depressive Disorder, run by H. Lundbeck A/S at 18 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 11 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 18 sites in Finland, Germany, Lithuania, Estonia. 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. Some participants in this study may receive a placebo. 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): number of correct symbols (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 NCT02279966, 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.