Major Depressive DisorderPhase 3NCT02279953
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
A Phase 3 study testing Vortioxetine 10-20 mg and SSRI in people with Major Depressive Disorder, run by H. Lundbeck A/S at 17 sites in 5 countries.
Trial 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… 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 SSRI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Oct 2014to Apr 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 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.
Who cannot join
- 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).
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- 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).
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Finland6 sites
FI002
Helsinki
FI003
Helsinki
FI005
Helsinki
FI001
Kuopio
FI006
Kupio
FI004
Turku
Germany5 sites
DE002
Berlin
DE001
Bielefeld
DE005
Bochum
DE003
Frankfurt
DE004
Mittweida
About this study
Official 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
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
- Being tested
- Vortioxetine 10-20 mg, Placebo, SSRI
- 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
PlaceboDrug
SSRIDrug
escitalopram, citalopram or sertraline
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine 10-20 mg | Experimental | daily, encapsulated, orally Receives: Drug: Vortioxetine 10-20 mg; Drug: Placebo |
| Vortioxetine 10-20 mg + SSRI | Experimental | daily, encapsulated, orally Receives: Drug: Vortioxetine 10-20 mg; Drug: SSRI |
| SSRI | Experimental | licensed doses, encapsulated, orally Receives: Drug: Placebo; Drug: SSRI |
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 (14)
Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])
Measured: Baseline to Week 8
Change in Trail Making Test (TMT) score: TMT-A; speed of processing
Measured: Baseline to Week 8
Change in TMT score: 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 Hamilton Depression Rating Scale-17 (HAMD-17) 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 University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
Measured: Baseline to Week 8
Number of adverse events
Measured: Baseline to Week 12
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)
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 completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 151 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
- NCT02279953
- Sponsor's protocol ID
- 15905A
- Other IDs
- 2014-000229-19, 2014
- Status last verified
- May 2017
- First submitted
- 21 Oct 2014
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 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 Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02279953
- Acronym / sponsor ID
- 15905A
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine 10-20 mg | Experimental | Drug: Vortioxetine 10-20 mg, Drug: Placebodaily, encapsulated, orally |
| Vortioxetine 10-20 mg + SSRI | Experimental | Drug: Vortioxetine 10-20 mg, Drug: SSRIdaily, encapsulated, orally |
| SSRI | Experimental | Drug: Placebo, Drug: SSRIlicensed doses, encapsulated, orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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, Vortioxetine 10-20 mg + SSRI |
| Placebo | Drug | SSRI, Vortioxetine 10-20 mg |
| SSRIescitalopram, citalopram or sertraline | Drug | SSRI, Vortioxetine 10-20 mg + SSRI |
Primary outcome
Change in Digit Symbol Substitution Test (DSST): number of correct symbols
Time frame: Baseline to Week 8
14 secondary outcomes
Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])
Time frame: Baseline to Week 8
Change in Trail Making Test (TMT) score: TMT-A; speed of processing
Time frame: Baseline to Week 8
Change in TMT score: 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 Hamilton Depression Rating Scale-17 (HAMD-17) 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 University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
Time frame: Baseline to Week 8
Number of adverse events
Time frame: Baseline to Week 12
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)
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 24 May 2017.
- Results EudraCT 2014-000229-19Link 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
17 sites in 5 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 SSRI in people with Major Depressive Disorder, run by H. Lundbeck A/S at 17 sites in 5 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 6 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Finland, Germany, Estonia, Serbia, Slovakia. 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): 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?
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 24 May 2017.